Irish Pharmachem Yearbook 2022

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T h e Largest I n d u s scope t r y Ye ofa r b o o k & B u y e r s G u i d e 2 0 2 2 global services.

Sharpest focus on data integrity.

BioPharma Product Testing www.eurofins.com/biopharma

From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance. As we have grown to become the world’s largest network of GMP product testing labs, we continue to uphold our founding promise of personal service and impeccable quality. When the world awaits your product, choose the lab that provides complete capabilities and rigorous quality systems you can trust.

Comprehensive GMP Testing Services

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Switzerland

Canada

India

New Zealand UK

Denmark

Ireland

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Cell Banking Services • Virology Services • Facility & Process Validation Chemistry • Biochemistry • Molecular & Cell Biology • Microbiology Raw Materials Testing • Primary & Secondary Package Testing

Professional Scientific Services® (PSS)

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Elite Technical Support 150 engineers, operating on and off site, nativespeakers in 10+ languages, ITIL accredited

Ensure critical enterprise technologies are always available. Our highly skilled, multilingual teams of engineers in Ireland, US, UK and New Zealand deliver a collaborative global service model that drives productivity with excellent customer satisfaction ratings.

Enterprise Service Desk

Lab IT Services

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24/7/365 remote and onsite support for all your business needs. With offices based in several countries, we can provide technical assistance in all of the top 10 European and Asian languages.

Westbourne provides onsite technical support for all your lab applications ranging from LIMS to CDS. We also offer a remote service for those wanted to save on desk-space.

We support companies for short term projects, from lab based CDS to Windows 10 IT upgrades. We can provide onsite staff from 1-9 months to support you through your project.

Westbourne IT - Experts in Global Enterprise Service Desk including Manufacturing and Labs IRELAND | USA | New Zealand, www.westbourneit.com, James.Symington@westbourneit.com +353 (0)21 431-4310


CONTENTS 2 Minister’s Foreword

Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment, explains why Ireland’s pharmaceutical sector is well-positioned to capitalise on the latest pharma and biopharma innovations.

4 Sector Overview

Matt Moran, Director, BioPharmaChem Ireland, examines the issues and opportunities facing the Irish biopharma and chemical sector in 2022, ahead of a new industry strategy report from BPCI.

8 Biopharma Ecosystem

Paul McCabe, Chair of BioPharmaChem Ireland and COO of VLE Therapeutics Ltd, assesses the achievements of Ireland’s biopharma sector in recent times and highlights the challenges and opportunities ahead.

12 IDA Ireland

Rory Mullen, Global Head of Biopharmaceuticals, IDA Ireland, examines why Ireland has been so successful in the global biopharma industry and what we need to do to ensure our future success.

14 Covid-19

When dealing with a global pandemic, speed trumps perfection, explains Michael Gillen, BioPharmaChem Ireland.

19 Corporate Tax Reform

Gerard Brady, Chief Economist, Ibec, argues that Ireland joining the new international agreement on corporate tax reform at the OECD is the right decision, at the right time.

50 SSPC

SSPC is a hub of Irish research expertise, delivering industryrelevant technical solutions for the pharma and biopharma sector.

53 Medtech

The Medtech Rising conference saw the presentation of the Irish Medtech Awards.

84 Chemical Solutions/Technical Services

Chemifloc Group provides specialist chemical solutions and technical services for multiple applications and use in industry.

86 Raw Materials

Paul Power, Strategic Sourcing & Supply Chain Executive, discusses how NCC are building flexibility and responsiveness into a supply chain during a global pandemic.

55 Work Force

Siobhán Dean, Senior Executive, BioPharmaChem Ireland, explains why attraction and retention of talent are key priorities for the sector in 2022.

88 ToF Measurement Instruments

The first cloud-connected radar level sensor from Endress+Hauser revolutionises measurement in storage tanks.

58 Coworking Laboratory Space

The Campus Cherrywood​offers coworking laboratory spaces for the first time ever in Ireland.

90 High-Purity Solvents

Univar Solutions offer high-purity solvents you can rely on for your pharmaceutical and biopharma production.

60 Pfizer

Pfizer has invested $40 million in its Grange Castle plant to produce its nRNA drug substance, the active ingredient in its Covid-19 vaccine.

92 Temperature Controlled Storage Solutions

Choosing the right cold chain solutions provider gives the pharmaceutical industry peace of mind, writes Aidan McCauley, Managing Director at Dawsongroup | TCS Ireland.

62 Certification

What ISO 50001:2018 means for your business.

63 Learning & Development

Susan Costello, Network Manager, BioPharmaChem Skillnet, explains how the BPC Skillnet has evolved into a network with unique capabilities to support learning and development.

94 Custom Buffers / Chemical Blends

Limerick-based A&C Bio Buffer was acquired by global materials provider Aceto in 2021.

96 Ingredients

Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application.

65 Specialist Integrated CDMO

22 Enterprise Ireland

Enterprise Ireland can help Irish biopharma companies to access innovation supports to start, grow and scale up, writes Deirdre Glenn, Head of Life Sciences at Enterprise Ireland.

24 NIBRT

Darrin Morrissey, CEO, NIBRT, advises on how Ireland can catch the next wave of advances in biopharmaceuticals.

28 Supply Chain

Enda Dempsey, BioPharmaChem Ireland, examines the continuing impact of Brexit on the pharmaceutical supply chain.

Hovione has 60 years of experience as a Specialist Integrated CDMO.

66 Laboratory Testing

Eurofins BioPharma Product Testing Ireland offers unique and unparalleled breadth of service and experience for Advanced Therapeutic Medicinal Products.

70 IT Services

Westbourne IT work with their client’s IT department as an outsourced extension of their team, delivering short, mediumand long-term projects in their laboratories.

98 Engineering

Foltech Engineering are a local engineering company, providing global solutions to the pharmaceutical and manufacturing sectors.

100 Waste Management

Indaver have introduced a host of safe, innovative and sustainable solutions for waste management.

102 Logistics & Transport

Ballinlough has evolved from a small service and repair company to offering full temperature controlled transport solutions.

34 Regulation

74 Laboratories & Analysis

37 Digital Health

76 Calibration

77 API’S, INTERMEDIATES & HPAPI’S

106 Process Data

The Health Products Regulatory Authority has provide expert regulatory support during the Covid-19 pandemic, writes Dr Lorraine Nolan, CEO, HPRA. Nessa Fennelly, Senior Executive, BioPharmaChem Ireland, explains the thinking behind the cross-sectoral ‘Where Digital Health Thrives’ campaign.

40 Disruptive Technology

A host of companies have come together to form a lighthouse partnership in disruptive technology to address the digital and sustainable transformation of the Irish small molecule manufacturing sector, writes Bryan O’Donnell, Janssen.

43 Manufacturing in Ireland

‘Manufacturing in Ireland - Today, Tomorrow and Beyond’ is an Ibec report which assesses what needs to happen to help Ireland’s manufacturing sector meet the significant challenges ahead.

47 PMTC

Sarah Hayes, Director, Pharmaceutical Manufacturing Technology Centre, highlights the valuable work the PMTC carries out across its key research areas.

A host of specialised and advanced equipment at their Ballina facility means that Charles River Laboratories are helping their customers to expedite new drugs and therapies to market. CalX: delivering world class calibration services. SK pharmteco’s mission is to partner with its customers to develop and reliably deliver pharma products through manufacturing and technical excellence.

The OSL garment dispenser from O’Flynn Medical provides rapid access to work wear. Bonner helps customers to unlock the value within their process data.

107 Documentation Solutions

78 Chemicals

81 Logistics

108 Packaging

82 WASTE SOLUTIONS

109 Brenntag Pharma

Dachser Ireland Chem Logistics has been a market leader in chemical storage and distribution for over 30 years. Kuehne+Nagel are set to open a dedicated 160,000 square feet pharma & healthcare warehouse in Dublin in early 2022. InOpSys is committed to providing circular waste or side stream solutions by building and operating mobile & modular purification installations on the customer site.

Irish PharmaChem is published by: Tara Publishing Ltd 14 Upper Fitzwilliam Street, Dublin 2. Tel: 00 353 (0)1 678 5165 Email: kathleenbelton@tarapublications.ie Web: www.irishpharmachem.com

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Managing Director: Patrick Aylward Editorial and Marketing Director: Kathleen Belton Editor: John Walshe Irish PharmaChem | Industry Buyers Guide 2022

105 Work Wear

TWi is a leading technical writing and information design service provider, offering high-quality, flexible, and scalable documentation solutions. Quitmann O’Neill is a well-known and trusted packaging distribution and value-added services company. Brenntag Pharma offers a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of API’s.

LISTINGS SECTION 111 112 118 128

Chemical Suppliers General Suppliers Company Listings Useful References

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Minister’s Foreword

Facing the future with confidence Ireland’s pharmaceutical sector is well-positioned to continue its growth and to capitalise on the latest pharma and biopharma innovations, writes Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment. I’ll begin by paying tribute to everyone who has worked in the life sciences sector in Ireland over the past two years. As well as playing a direct role in our response to the pandemic, your efforts have kept other, nonCovid-19 related manufacturing operations going, and ensured that critical supply chains stayed up and running despite incredibly difficult circumstances. Thank you for your resilience and endeavour. Ireland’s long track record as a welcoming environment for global businesses is due to many factors. Our continued commitment to the European Union and its single market is a selling point that attracts multinational companies to set up operations and create jobs in Ireland. Our progressive, outwardlooking perspective as an open economy means that we have a reputation as a proenterprise jurisdiction. Investment in life sciences will continue to be driven by our excellent regulatory compliance record, strong Government support for research and development, and excellence in biopharma manufacturing.

Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment

Backing the sector to grow and prosper I’m determined to see Ireland’s pharmaceutical sector continue to grow and prosper. We are targeting 80 new investments and 5,000 new jobs in the sector, through IDA Ireland, by 2024. Foreign direct investment was central to our last recovery and will be crucial now as we rebuild after the pandemic. The biopharmaceutical industry is one of our largest industries. There are now more than 40,000 people employed in the sector, with over 90 manufacturing sites embedded in communities right across Ireland. All the top 10 global pharmaceutical companies and 13 of the top 15 medical technology companies have operations here; that’s a remarkable achievement. A further attractive element of our ecosystem is the National Institute for Bioprocessing Research and Training (NIBRT), which was established by the Government to support the growth and development of the biopharma industry in Ireland, and which has transformed Ireland’s capacity to support biopharmaceutical

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Minister’s Foreword training and innovation. An important element of Ireland’s attractiveness to FDI is the quality of our education system, and NIBRT and the dedicated life science research centres have been a driver of this success, supporting the sector and encouraging the industry to spend over €2 billion annually on R&D. Our Covid Products Scheme, launched last year to support the research, development, and production of Covid-19 related products, also warrants a mention. Funding is available for companies making PPE and other Covid-19 related products to expand, thereby increasing supply and reducing our dependence on imports.

Strong growth in biopharma specific services In addition to seeing significant manufacturing investments, we are also seeing strong growth in biopharma specific services. Ireland is well placed to deal with the complex data, quality, regulatory and supply chain issues associated with the growing trend towards personalised medicines and increasing regulatory requirements. New technologies such as Advanced Therapy Medicinal Products (ATMPs) represent an area of great potential for Ireland. With the right collaboration between industry and Government, we can harness the next wave

Irish PharmaChem | Industry Buyers Guide 2022

of innovation, while sustaining, and growing, the high levels of investment we have seen over several decades.

Investing in cell and gene therapy NIBRT’s planned €20 million investment in cell and gene therapy will provide the sector with a supply of manufacturing professionals, which will be critical to ensure Ireland does not miss out on the next wave of biopharmaceutical manufacturing. The industry’s responsiveness to environmental concerns is also increasingly in evidence, with the sector responding to global environmental and sustainability concerns. As we look to 2022 and beyond, our focus is on maintaining Ireland’s reputation as a centre of excellence for the biopharmaceutical sector and growing the industry here. We are aware that competition for global investment is intense, but we are confident that we can remain a world-renowned home for global firms. We know how important the sector is to our economy and we look forward to attracting and sustaining further investment from the sector well into the future. I wish the Irish PharmaChem Yearbook every continued success in 2022.

Leo Varadkar TD, Tánaiste and Minister for Enterprise, Trade and Employment

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Sector Overview

The availability of the right talent pool to ensure that the sector remains competitive and is able to evolve remains vital.

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Irish PharmaChem | Industry Buyers Guide 2022


Sector Overview Matt Moran, Director, Matt Moran, Director, BioPharmaChem BioPharmaChem Ireland, Ireland, examines examines the issues andthe issues and opportunities facing opportunities facing the Irish the Irish biopharma biopharma and chemical sector and chemical sector in in 2022, 2022,ahead ahead a new industry of aof new report from BPCI. industrystrategy strategy report

A focus on manufacturing As we move through and hopefully out of the pandemic, the sector remains very robust and continues to grow. Exports from the entire sector - that is chemicals and biopharma products - broke the €100 billion mark in 2020, with biopharma alone accounting for €96 billion of that number. Ireland is the second highest exporter of complex pharmaceuticals in the EU, second only to Germany. The future is bright for the sector. However, now is not the time for complacency or resting on our laurels. The need to focus on manufacturing has never been stronger. A wide range of challenges face not only the biopharma and chemical manufacturing sector but the entire manufacturing sector. This prompted Ibec to come out with its ‘Manufacturing in Ireland Today, Tomorrow and Beyond’ report – more on that later. BPCI is presently working on a new industry strategy report which it plans to bring out in mid-2022. Companies have already met and discussed its content in some detail. Six broad thematic areas have emerged:

Advanced Therapeutics: Advanced Therapeutics, including Cell and Gene Therapies and advanced vaccines such as the recent Pfizer-Biotech mRNA Covid -19 vaccine, are likely to provide therapies for a wide range of illnesses, some existing but many unmet. Commentators estimate Irish PharmaChem | Industry Buyers Guide 2022

that there could be over 2,000 clinical trials ongoing in the space globally. This will present opportunities for manufacturing but also for specialist services; Ireland needs to be a part of this. Local contract CDMO APC has recently established a GMP manufacturing facility for CGT – APC/VLE.

Active Pharmaceutical Ingredients (APIs) : APIs have formed the traditional core of the sector, where many of the large multinationals first established in the country – companies such as Pfizer, Eli Lilly, MSD, Janssen etc. These companies still represent a very valuable component of the industry. As global networks come under increasing cost pressure, it is vital that Irelands API sector stays competitive and continues to grow. A Lighthouse Project on Factory 5.0 is established and looks to digitise the sector, as well as driving sustainability in the industry.

Global Business Services: A number of biopharma companies, including Pfizer, Novartis, Eli Lilly, Jazz Pharma etc. operate Global Business Service (GBS) centres in Ireland. These were originally set up to manage finance for corporate networks. Recently, they have diversified into other areas, including HR, management of medical information, connected health etc. Such centres are becoming more aligned with the manufacturing part of the industry and could look to establish control towers to

manage supply chains in CGT products for instance.

Talent: The availability of the right talent pool to ensure that the sector remains competitive and is able to evolve remains vital. As companies pivot and digitise their operations, the type of person needed to work in the sector necessarily needs to evolve also. BPCI has established a very active diversity group and has also established a Laboratory Apprenticeship Programme, which now runs successfully out of TUD and WIT.

Contract Development and Manufacturing (CDMO): The CDMO sector is evolving and expanding; this is being driven by existing operators but also the transfer of some existing API operations - for example, Thermofisher’s purchase of the GSK site in Ringaskiddy and SK biotek’s purchase of the BMS site in Swords, Co. Dublin. There is further potential to expand this sector, building on Ireland’s excellent reputation for quality and strong regulatory compliance. The country is ideally placed too, sitting at the bridgehead between the US and Eurasia.

Pharma 4.0/5.0: BPCI conducted a workshop with Innopharma in late 2019 just before the pandemic hit. They have continued to work on this and in fact, 4.0 has since evolved to 5.0

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Sector Overview

Manufacturing in Ireland Manufacturing in Ireland

Today, Tomorrow & Beyond

Ibec’s recent report, ‘Manufacturing in Ireland - Today, Tomorrow and Beyond’, shines a firm spotlight on the scale of the manufacturing sector in Ireland. to encompass sustainability and the role of the employee in embracing 4.0 concepts. BPCI sees this as a way of protecting the attractiveness of the sector as well as ensuring that it meets its carbon reduction commitments.

Lighthouse Project Factory 5.0 A consortium of companies led by J&J and supported by BPCI and IDA Ireland has been established to develop a roadmap to support an ecosystem to bring the small molecule API sector towards the principles that underpin Factory 5.0. The cluster comprises a number of captive API companies, including Janssen, Pfizer, MSD, Merck etc., a range of CDMOs (including SK biotek and Thermofisher), as well as some technology companies, including Analog devices and Siemens Healthcare. Each of the API companies in the cluster have been assessed by Irish SME Innopharma to gauge their level of maturity along the road to 5.0. A portal for collaboration and new business opportunities has been built. The group will now strive to build an ecosystem that can be rolled out to the rest of the industry, including drug product and biotech manufacturers.

Manufacturing in Ireland Ibec recently conducted a survey of its manufacturing member companies to input into a recently published report, ‘Manufacturing in Ireland - Today, Tomorrow and Beyond’. This report shines a firm spotlight on the scale of the manufacturing sector in Ireland. The sector spans everything from successful indigenous Irish companies to global companies of huge scale. Key statistics revealed in the report include:

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260,000 employed in Irish Manufacturing – 12% of total employment in the economy; • Spend of €12.5 billion wages and employment taxes annually; • Spend of €19 billion on goods and services from other suppliers in Irish economy; • Irish owned manufacturers grew their sales globally by over 80% between 2010 and 2019; • Value added per employee was up 25% from 2010 to 2019; • Inward FDI manufacturers grew exports by 44% from 2010 and 2019; • Irish manufacturers employ 150,000 overseas, including 60,000 in the US, 25,000 in the UK; • 29% of manufacturing jobs are in high tech sectors, four times the EU average. Irish manufacturing has successfully moved up the value chain from primary processing of agricultural products and low-level assembly in the 1960s to biopharmaceuticals, medical technology, food production and high technology manufacturing in the present day. The Irish manufacturing sector has a very large footprint in relation to the size of the country. With just 1% of the EU’s population, Ireland accounts for 5% of its manufactured goods. By comparison with our nearest neighbour, the UK is 13 times our size in terms of population but is only 2.7 times larger in terms of manufactured goods. A number of factors have contributed to this: • A skilled and flexible workforce; • A stable, transparent and flexible tax regime; • Membership of the EU Single Market; • A regulatory regime conducive to doing business globally;

• •

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A stable Industrial Relations regime; A strong and reliable business culture. Ireland offers a platform and gateway for companies to access 450 million customers in the EU. The report contains a number of industry case studies, with Pfizer providing the case study for the biopharmaceutical sector. A number of recommendations are made, including: • The need to improve the R&D Tax Credit Scheme; • Taking a whole of Government approach to development and implementation of digital policies; • Acceleration of the delivery of a National Broadband Plan; • Ensuring National cyber security and data protection capacities are in place; • An end-to-end skills strategy for the manufacturing industry; • Incentivisation of the co-location of R&D capacity with high end manufacturing; • Adoption of a cost-effective approach to emissions reduction; • The EU to continue to champion the openness of trade and investment with the retention of access to the UK market; • To critically assess all new regulations during development to avoid any negative impact on the business environment. Finally, it is very encouraging to see the announcement by the We are Pioneer Group to establish a Life Sciences Park at Cherrywood in Dublin. This will include wet laboratory space, a bio incubator and support for startups. BPCI has established an indigenous biotech group to see what can be done to support start-ups in life sciences and to build out the entire cluster in the country. Irish PharmaChem | Industry Buyers Guide 2022


Not your average CDMO... Not your average CDMO... Viral Vector Development Track-record with the FDA and other Not your average CDMO... Viral Vector Development Track-record withauthorities the FDA and other A Partnership global regulatory

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Biopharma Ecosystem

Creating a broader & deeper biopharma ecosystem

Paul McCabe, Chair of BioPharmaChem Ireland and COO of VLE Therapeutics Ltd, assesses the achievements of Ireland’s biopharma sector in recent times and highlights the challenges and opportunities facing us if Ireland is to realise its future potential. I have been the Chair of BPCI (the industry body within Ibec representing the biopharma, pharma and chemical sector in Ireland) for the last 20 months. As such, I have been in the perfect position to see the achievements delivered by our sector, the challenges within the industry and the opportunities to ensure that Ireland remains a global leader.

Achievements The biopharma sector, being an essential business, has not only remained open since March 2020 but in most cases had to change strategies and run faster than ever before throughout the pandemic, despite the challenges. Almost all companies in Ireland’s biopharmachem sector stayed operating, manufacturing, testing, packaging, shipping and distributing critical medicines to patients around the world. I certainly would like to acknowledge the tireless efforts of every one of our member companies for keeping the show on the road and delivering critical therapies to patients globally. • The last 18 months has been a very positive period for the industry; • The sector is now worth €100 billion to the economy in terms of exports, which equates to over 65% of our national GDP in the last year;

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• Despite uncertainty, investment in capital

infrastructure has continued to grow during this time. Currently, there are over 60,000 highly skilled people directly and indirectly employed in the sector. Employment has continued to grow during the pandemic, and the expectation is that this will increase by up to 10,000 jobs over the next five years. The sector has been in a positive spotlight in the public eye for the last 20 months. • Whilst many were concerned that the development of an effective vaccine could take more than five years, the sector dug in and created several vaccines for Covid, some with new technologies, in record time. • Governments understand the supply chain more than even before and as such, I believe there is a chance now to implement changes and improvements for the sector, while we have the attention required.

Challenges We do of course still have challenges ahead of us. These include: Covid: Covid-19 has not gone, and its aftereffects will likely remain with us through 2022 and 2023. Changes to supply chains and demand are

Paul McCabe, Chair of BioPharmaChem Ireland and COO of VLE Therapeutics Ltd. Irish PharmaChem | Industry Buyers Guide 2022


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Biopharma Ecosystem already impacting lead times for materials, consumables and equipment, and this will continue for some time OECD / Corporate Tax changes: Heightened pressures on our national corporate tax rate have resulted in the recent change in our national rate from 12.5% to 15%. This will likely put FDI under more scrutiny in the global boardrooms, especially on new investments, and challenges Ireland’s value proposition; we need to focus now on bolstering the other elements of this proposition. Lack of Pharma SME sector: Given the impending changes to our FDI model, it is clear that we are currently hugely reliant on these MNC companies, and we lack a robust indigenous SME sector. This needs to change to create a more balanced ecosystem. Competitiveness: The biopharma sector is under increasing pressure to continue to provide affordable healthcare solutions to society. We are also moving to personalised medicine and hence even more agile supply chains will be needed. Nationally, the dangers of wage inflation could also undermine our competitiveness. Future skills needs: We continue to struggle to encourage students into relevant & appropriate STEM courses and careers. Our challenge is to increase the pipeline of talent into the sector. Diversity & Inclusion, particularly gender balance, which is a particular passion of mine, has come

under pressure during the pandemic and we need to put it back on the table if we want to encourage more skilled female talent into STEM careers. Digitisation & speed to market: We have yet to grab the window of opportunity to digitise our manufacturing and supply chains, which can optimise the cycle time from product development, through clinical to commercial manufacture, thus improving the speed to market for critical therapies. Advanced Therapeutics - grabbing the next frontier: Based on the quantum of molecules currently in clinical phase trials, we will expect to see these commercialise over the next five years. As a country, we are making very small steps in this area and we are way behind other countries already, the UK and US, obviously, but also Israel, Belgium, Netherlands, Nordics, etc. Sustainability: This topic has risen up to the top of the corporate agenda for all companies in all sectors and is driven by a number of factors, including: investor expectations; employee expectation that companies are focused on CSR activities; and the effect of Covid demonstrating that the current global supply chain is not sustainable, impacting on logistics, which directly affect the ability to deliver critical medicines to patients.

Opportunities There are a host of opportunities ahead for the sector, however, which include: BPCI Strategy Development: BPCI’s role is to stay abreast of industry trends. At our recent annual strategy meeting, working with member companies, we continued to evolve our strategy for the sector to support the growth of the sector. From an operational & tactical perspective, BPCI have 29 active working groups in place and all stayed active during the pandemic. OECD / Corporate Tax changes: BPCI continue to work closely with the BPCI board and member companies to understand the concerns of companies in Ireland and develop messaging to Government to support development of appropriate policy.

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Biopharma Ecosystem Competitiveness: BPCI continue to work closely with the BPCI board and member companies to understand the concerns of companies in Ireland to maintain a competitive manufacturing base into the future to underpin the sustainability of highquality jobs and export-led economic growth. Indigenous SME sector working group: The aim is to understand what the issues (such as encouraging Government to change the current funding model for the SME sector) and requirements are to develop a robust, broad and deep biotech ecosystem in Ireland to deliver a more balanced and sustainable future. Advanced Therapeutics working group: The aim is to identify all aspects of this opportunity, from skills, to funding, to ecosystem, to clinical competence to deliver a new node of the biopharma sector in Ireland. Digitisation working groups: Several cross-sectoral working groups have been created, including Industry 4.0/5.0, Digitisation of Advanced Therapeutics supply chain (+EY & IDA), a Lighthouse Pharma 5.0 Project and a Digital Health Initiative, working with Medtech Ireland & Technology Ireland. Future Skills Needs working groups: Several cross-sectoral working groups and programmes for the sector have been created, including a Future Skills Needs initiative, the Lab Apprenticeship Programme, BioPharmaChem Skillnet, and our Diversity & Inclusion working group in conjunction with 30% Club Ireland. Sustainability working groups: A number of cross-sectoral working groups and programmes for the sector have been created, including API (the New Paradigm), CDMOs & Ireland and Global Pharma Business Services. BPCI, in conjunction with the Irish Pharma Awards, now have a strong focus on CSR, as well as the environment and sustainability, with several awards specific to these areas

The biopharma sector, as an essential business, has not only remained open through the pandemic but often had to amend strategies and run faster than ever before. aimed at heightening awareness and driving improvements in Ireland.

On a personal note I will continue as Chair of BPCI until this time next year and look forward to working with the Ibec BPCI team and our member companies to develop a strategy to grow a robust and sustainable sector. Also, earlier this year, after 30+ years in FDI MNCs, I made the move to an Irish biopharma SME called VLE Therapeutics. It is a start-up GMP manufacturing company, spun out of the awardwinning APC Process Development business, based here in Cherrywood in South Co. Dublin. VLE Therapeutics is being developed to extend the value chain for our clients from Process Development into GMP manufacturing and thereby helping them get their medicines to patients more effectively and efficiently. It has been an incredibly exciting year in the new role: the ability to move at speed, the live innovation, the fresh and energetic culture, and the opportunity to operate with more agility and flexibility has been fantastic.

It has also been very interesting, getting to see the challenges for biopharma SMEs in Ireland – the lack of a cohesive ecosystem of SMEs/MNC/academia, the ineffective funding mechanism to support its growth (although I would call out Enterprise Ireland specifically for their solid focus and support to SMEs) and elements of complacency around the sector in general. Personally, I am looking forward to the challenges and opportunities ahead and to develop VLE Therapeutics, to grow our APC-VLE value proposition as lifecycle partners and as a result to become Irish-born global pioneers.

Summary The opportunities for the sector are incredible, from Advanced Therapeutics to Industry 5.0, to the development of an indigenous SME sector, to evolving other elements such as API, CMDO and Global Business Services. Finishing on a quote, as we all work on changing our strategy for the sector, remember: “The secret to change is to focus all of your energy not on fighting to keep the old, but instead on building the new.”

The pharma and biopharma sector created several vaccines for Covid, some using new technologies, in record time.

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Irish PharmaChem | Industry Buyers Guide 2022



IDA Ireland

Helping Ireland to prosper in biopharma 2021 has been another challenging year for us all as the Covid-19 virus continues to mutate and challenge the vaccines and therapeutics that have been developed recently by the global biopharmaceutical sector. The ongoing pandemic has certainly continued to focus attention on the innovation capabilities of our industry. This time last year, I was hopeful that the successful development of several vaccines, including the novel mRNA vaccines, would eliminate the virus quickly, but the battle continues. The ability to quickly adapt the mRNA vaccines to new strains, together with the impact of new anti-viral therapeutics, currently seeking regulatory approval by Pfizer and MSD amongst others, will hugely improve outcomes over the next year, so hopefully the end is in sight in 2022. Ireland’s globally recognised manufacturing cluster has become more involved in the fight against Covid over the last year and is now an essential part of both the vaccine and therapeutics supply chains. It is fantastic to see major global companies demonstrate confidence in Ireland as part of their global supply chains, making sure that these new innovative medicines get to patients. Covid-19 continues to highlight the risks inherent in these global supply-chains. Some commonly used medicines and ICU drugs were initially in short supply due to the complexity of these supply chains. This has provided opportunities for Ireland as we see more products being manufactured in Europe and the US. However, as biopharma is one of the few global economic sectors showing resilience during this pandemic, we are seeing increased global competition for new mobile FDI investment in life sciences. In the last decade in particular, Ireland has seen the rise of biologics manufacturing, with significant capital investment resulting in the development of 20 state-of-the-art

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Rory Mullen, Global Head of Biopharmaceuticals, IDA Ireland, examines why Ireland has been so successful in the global biopharma industry and what we need to do to ensure our future success. in Waterford during 2021, demonstrating the regional spread of the industry.

Why Ireland?

February 2021 saw Takeda announce an expansion of its cell therapy manufacturing operations in its Grange Castle campus. manufacturing plants. The impact this has on the Irish economy cannot be overstated through the value of exports, purchases of both equipment and services, in addition to the salaries of those highly skilled employees at plants all over the country. Late in 2020, MSD announced their plans for the development of a new biologics manufacturing facility on their Dunboyne campus. If we look at the impact this has across the country, there are now many clusters around our key towns and cities. Both Cork and Dublin have had strong clusters for a long time, but we now also have clusters in Waterford, Athlone, Sligo and Dundalk, along with major investments in Limerick, Carlow, and Westport. These can, in many cases, be the backbone of these regional economies. We consider Ireland, which is smaller than some US states, as one cluster within the global biopharma landscape. Both Repligen and Horizon announced the development of new manufacturing operations

Why Ireland and what do Irish people bring to the picture? As previously mentioned, we have seen strong investment in more recent years in biologics. We are now seeing expansion projects from companies that invested in new biologics operations six, seven or even 10 years ago. This shows the continued confidence companies have in Ireland. Much of this, in IDA’s opinion, is down to two key elements: skills and our regulatory environment. Taking skills first, we originally saw this as the key differentiator back in the mid-2000s, understanding that if we could produce the skills for this sector, we would win more investment. With the launching of NIBRT (National Institute for Bioprocessing Research and Training) in 2007, we instigated a plan that has become a central attractor in Ireland’s success. NIBRT today trains over 4,000 people annually in all types and lengths of courses around biologics manufacturing and collaborates on research specifically related to industry problems. Skills are the key currency in future success for global biopharma companies and Ireland leads in this area. Our second strength is our regulatory environment, which is second to none globally,

Irish PharmaChem | Industry Buyers Guide 2022


IDA Ireland led by the Irish regulator, the HPRA (Health Products Regulatory Authority). The HPRA is a strong and committed member of the European EMA network, chairing several key committees and engaging on all topics relevant to the growing community of companies in Ireland. It is also clear that companies based in Ireland get clear direction and thorough audits of their manufacturing sites from the HPRA, which ensures high levels of compliance for all their Irish operations. This culture of professionalism has permeated across all the companies in Ireland, with employees in each company understanding that their actions affect every company and not just themselves. With Brexit, this has seen an increased understanding of the regulatory needs of our country and the readiness to also make sure that Irish patients get the medicines they require.

A growing industry Throughout the pandemic, the Irish biopharma industry has continued to grow. Biologics is becoming a mature sector; API is a tried and tested manufacturing process and there is a move to more personalised medicines, particularly in the Cell and Gene Therapy areas. So what must Ireland do to make sure the future is as successful as what we have to date achieved? The announcement in September 2021 of a new $360m small molecule API manufacturing facility in Dublin by Astra Zeneca was an endorsement of the skills available in Ireland in this area and a vote of confidence in the industry. When it comes to the manufacturing of API’s, and pharmaceuticals in general, we need to see constant transformation of our existing sites, ensuring that they are flexible enough to handle the new small molecule products that will still account for more than 50% of global new medicines. Transformation of sites will of course require the constant upskilling of staff and then site investments in terms of new equipment, technology platforms and manufacturing processes. We in IDA Ireland will continue to work with our clients on an ongoing basis to support training needs and process R&D across the country. As I have already mentioned, the biologics industry is maturing and we are now seeing expansion projects from existing investors. Many major new plants are still under construction or being validated, including MSD in Dunboyne and Swords and WuXi in Dundalk. Each of these have been major construction projects but what is next? As we look out across the global landscape, we appear to be reaching a stage where for the major companies at least, there is now sufficient manufacturing capacity in place. With the continued growth of the CDMO model though, it will be interesting to see what comes next. We are already seeing this trend in small molecule, with SK acquiring the BMS API plant Irish PharmaChem | Industry Buyers Guide 2022

MSD Biotech Dublin remains at the forefront of the biopharma industry in Ireland. in Dublin and Thermo Fisher acquiring the GSK API facility in Cork. In this context though, the first biologics CDMO in Ireland will be WuXi. We believe there is space for more, as many global CDMOs already have relationships with our clients elsewhere on the globe. The increased demand for vaccines may also provide opportunities.

ATMPs to transform the industry In the long-term, Cell and Gene Therapies or ATMPs (Advanced Therapeutic Medicinal Products) are likely to transform the industry. With the commercialisation of two autologous CAR-T therapies and the recent approval of a spinal muscular atrophy (SMA) gene therapy product, these therapeutic products offer treatments for patients with unmet needs and are increasingly coming into focus. However, there are significant price tags associated with these therapeutics, ranging from $400k to $2.1 million dollars. These therapeutics have many characterisation and manufacturing challenges. This presents opportunity for product innovators, suppliers and academics to collaborate and design process technologies to streamline the manufacturing steps. Developments are aiming to offer alternative options and more scalable solutions; for example, the development of allogeneic products using donor cells, which should over time start to see the development of a more defined manufacturing process. This will again play into the skills and experience of Ireland, where manufacturing is our sweet spot and where we have gained our international reputation for delivery. Hopefully, Takeda’s announcement in February 2021 of an expansion of its cell therapy manufacturing operations in its Grange Castle campus is the first of many in this area. Who will the future players be in this new scientific area which promises so much for patients? We have already seen significant mergers and acquisitions in the ATMP space. Gilead acquired Kite for US$11.9 billion and Celgene acquired Juno for US$9 billion. Roche acquired Philadelphiabased Spark for US$4.3 billion in 2019. There have also been some major investments

Rory Mullen, Global Head of Biopharmaceuticals, IDA Ireland.

by Pfizer in gene therapy capabilities. These give some indication that the major global biopharma companies will be developing in this space. In addition, with the personalised nature of these medicines and the exciting opportunities in new, more targeted disease areas, there is a group of new companies that are developing independently in this space. Ireland’s skill base, track record and regulatory reputation will allow us to be a strong player in this new sector over time, but we must put our hand up now in our companies, our educational institutions and with Government to make sure everyone is aware of the opportunity and the imperative that our country continues to lead in future medicines manufacture. This area today has over 1,000 potential products in clinical trials and it is now that those companies will be deciding where to do further development work, where to manufacture and when to internationalise from their home base for these new products. NIBRT and a cohort of stakeholders within the Irish ecosystem have already been working on the requirements for Ireland to be successful, along with the first training programmes. A key stakeholder has been the REMEDI research team in Galway, who have been doing pioneering work in the cell therapy space. In conclusion, I look forward to helping the Irish industry continue to grow and thrive in 2022.

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Covid-19

Speed of response critical to combatting pandemic When dealing with a global pandemic, speed trumps perfection, explains Michael Gillen, Senior Executive, BioPharmaChem Ireland.

“Be fast, have no regrets; you must be the first mover. If you need to be right before you move, you will never win. Speed trumps perfection. The greatest error is not to move, the greatest error is to be paralysed by the fear of failure.” - Dr Michael Ryan, Chief Executive Director of the WHO Health Emergencies Programme

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Covid-19

Speed trumps perfection: words that can be traced back to the plan-do-check-act (PDCA) cycle used for the control and continuous improvement of processes and products. Indeed, this PDCA approach is the basis of all safety management systems, including that published by the Health & Safety Authority in 2006. The importance of this mantra is evident in comparing the approaches taken by Ireland (specifically the Republic of Ireland, as Northern Ireland choose to adopt the UK approach) and our nearest neighbour, the UK. On January 31, 2020, two members of a family became the first confirmed cases of Covid-19 in the UK. Yet it was March 23, a full 52 days later, before a full lockdown was announced: the UK death toll had reached 281 by March 22. On February 29, 2020, the first positive case of Covid-19 was confirmed in the Republic of Ireland. On March 12, 27 new cases were confirmed, bringing the total cases in the country to 70; the first recorded fatality had been noted the day before. In response to this increase in cases, then Taoiseach Leo Varadkar TD announced the closure of all schools, colleges and childcare facilities until March 29. This marked Ireland’s transition from the containment phase towards the ‘delay phase’ in its strategy to combat the spread of the virus.

Lockdown On the evening of March 27, the Taoiseach announced a series of measures which he summed up as “Stay at home”. This was the start of our lockdown and came 26 days after our first recorded case, compared to a 52-day gap in the UK. By April 10, the number of confirmed fatalities in the UK was 8,958 (Source: John Hopkins University); on the same date, the number of confirmed Irish PharmaChem | Industry Buyers Guide 2022

fatalities in the Republic was 287 – coincidently, this was the weekend that the official global death toll passed 100,000 (https:// gisanddata.maps. arcgis.com/apps/ opsdashboard/ i n d e x . h t m l # / bda7594740fd4029 9423467b48e9ecf6). It wasn’t just our politicians and public health officials that employed speed in those uncertain times; Ibec utilised their various networks to gather information on what was and wasn’t working in managing the spread of the virus.

Biopharmachem leading the way Within BioPharmaChemical Ireland, the EHS working group started weekly meetings where sites shared how they were managing. This in turn fed into the wider People need to adopt behaviours when case numbers rise and the quicker this can be done, the quicker we can resume what has become the new normal.

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Covid-19

Ibec information matrix, such that when the Government, through the work of the Labour Employer Economic Forum (LEEF), decided to publish the ‘Return to work safely protocol’ in May 2020, a lot of the advice had originated from the biopharmachem sector. Since then, Ibec has published countless documents, guidance notes, webinars, and other material to help member companies manage in these unprecedented times. Areas covered include:

Business continuity planning – managing outbreaks in the workplace, travel policies, etc; • Occupational health and safety advice – Covid-19 FAQs, data protection guidance and vaccinations, various workplace controls, etc; • Human resources guidance – workplace events (key considerations), hybrid working, mental health and well-being in uncertain times, etc. All of the above can be accessed on the dedicated Covid-19 page on the Ibec website: https://www.ibec.ie/employer-hub/ covid-19.

Vaccines offer hope When the country went into lockdown in March 2020, no one knew when this would all be over. 2020 was a tough year for many but as the year progressed, talk of vaccinations became a beacon of hope. Vaccines have been around since Edward Jenner’s’ lifechanging paper in 1798, when he described using cowpox as a vaccine against smallpox, a disease that has finally been eradicated from the world (a sobering point to note;

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the last naturally occurring case of smallpox was diagnosed in 1977, 180 years after the vaccine was produced!). Throughout the early months of 2021, and as case numbers rocketed following on from the easing of restrictions leading up to Christmas 2020, frustration grew at the slow roll-out of vaccines. However, since the late spring, the rate of roll-out has catapulted Ireland to being one of the most vaccinated (against Covid-19) countries in the world.

Uncertainty taking hold again As I write this article in mid-November 2021, uncertainty again appears to be taking hold. Despite more than 89% of the eligible population (everyone over the age of 12) being fully vaccinated, the virus continues to spread. Since the phased return to work began on September 20, the 14-day average (per 100,000) has increased from 188 to 1160 on November 16. This is not because of people returning to their offices; it is as a consequence of thinking it’s all over. The vaccine is playing its part – numbers getting very sick have fallen dramatically. But the vaccine on its own will not eradicate Covid-19. People need to adopt behaviours when case numbers rise and the quicker this can be done, the quicker we can resume what has become the new normal. There will be further high and lows as the world continues to adapt to this new norm. But we are in a much better place than this time last year. Now we know that vaccines work. The booster campaign is already producing remarkable results in our older cohorts. Vaccine approvals have started for children aged 5-12 and this will hopefully tackle the biggest current vector for transmission. The key is to move quickly when new tools become available. As Michael Ryan stated, “Speed trumps perfection”!

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Astellas Ireland Co., Ltd. Kerry Plant Killorglin Co. Kerry Astellas Ireland Co., Ltd. Damastown Road Damastown Industrial Park Mulhuddart Dublin 15


Corporate Tax Reform

Gerard Brady, Chief Economist, Ibec, argues that Ireland joining the new international agreement on corporate tax reform at the OECD is the right decision, at the right time.

IRELAND after 12.5% Ireland is a small, very open, regional economy in a global context. Our growth story over recent decades has been synonymous with attracting wave after wave of new foreign direct investment to supplement what was, at the outset, a weak capital base. Each wave of FDI has seen us move into increasingly complex and higher value areas of production and export. We can see the impact of the substantial MNE (multinational enterprise) activity in Ireland in the fact that multinational companies account for one-fifth of Irish private-sector jobs, onethird of wages, two-thirds of business Capex and €9 in every €10 of our exports. This is a substantial contribution to national economic wellbeing. Ireland also provides a welcome climate for companies. This can be seen in the substance that takes place here: Today, Ireland has all of the top 10 global technology companies, 18 of the world’s top 25 MedTech companies and 18 of the world’s top 20 biopharma companies and has the highest proportion of high-tech exports in Europe; We are the second largest exporter of medical devices in Europe, including leading Europe in the export of contact lenses, test Irish PharmaChem | Industry Buyers Guide 2022

kits and diagnostics, pacemakers and coming second in the export of orthopaedic products; We are also the second biggest exporter of complex pharmaceutical goods and medicines in the EU after Germany, including leading Europe in the export of antisera and immunological products and being Europe’s second-largest exporter of vaccines; Ireland is also the fifth largest exporter of data processing machines in the EU and manages half of the world’s leased aircraft fleet. In this context, it might be easy to see the recent announcement that Ireland would be joining the new international agreement on corporate tax reform at the OECD as a radical shift in our historically stable industrial policy, but it is the right decision, at the right time.

Changing corporate tax landscape The last number of years have seen a significant change in the Irish corporate tax landscape, which has played such a crucial role in the development of this ecosystem of substance. Since 2018 alone, we have seen the introduction of Controlled Foreign Company Rules, the BEPS Multilateral Instrument, an ATAD compliant Exit Tax, Hybrid Mismatch Rules, updated Transfer

Pricing rules and Mandatory Disclosure Rules. The coming years are also likely to see moves toward implementation of the ATAD Interest Limitation rules, Public Country-by-Country Reporting, and the consideration of moving to a territorial tax regime. This is all before we get to broader discussions about the changing international tax landscape. Accession to the OECD accord may pose a competitiveness challenge. A 15% effective tax rate will close the competitiveness gap to other EU competitors, with effective tax rates close to or below 20%, such as the Netherlands, Belgium, Sweden, Denmark, Switzerland, and Finland. Ireland’s regime, however, will retain some key advantages. The Government’s positioning at the OECD in recent months has reaffirmed Ireland’s strong commitment to regime certainty in the face of major external pressure. Importantly, the support for 12.5% as a legitimate rate of corporate tax had support across the political spectrum in all major political parties. This, along with our strong track record of delivering returns on investment, means Ireland is a known quantity when many countries are changing their offerings on tax, trade and openness to people.

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Corporate Tax Reform A large market for trade and talent We also have access to a large market for trade and talent. Companies in Ireland know that they have access not only to a skilled domestic pool but a pool of skilled labour across 27 other EU states, the UK under CTA, and further afield. We have the youngest country in Europe, the highest share of working age people with a third level education, and a level of openness to skilled workers which is unmatched. Onein-every-four millennials in the Irish workforce come from abroad. The EU average is one-inevery-ten workers. Surveys also regularly show some of the strongest pro-immigration views in Europe. If people are crucial to your business, Ireland will not be found lacking for talent. Finally and crucially, Ireland will remain a key proponent of economic openness in an increasingly uncertain world. Ireland’s trade openness is crucial to our economic model, not just to trade but also to people. This will not change on the political winds. By building on these strengths, Ireland can continue to thrive, but we also have work to do here at home.

Meeting the competitiveness challenge Various studies have shown the impact an increased effective tax rate, all else equal, could have on Ireland’s attractiveness as a location for FDI. But all else will not remain equal. From an Ibec perspective, we have been clear for several years that we will need to meet this competitiveness challenge by additionally investing in other growth levers. This means scaling public R&D investment, making us a leader for knowledge exchange and intellectual property, prioritising investment in education, skills and critical infrastructure and providing political leadership to prioritise, coordinate and realise Ireland’s digital opportunity at national and EU levels. We also have an opportunity to maximise what we have within the construct of a new international tax settlement. Tax will be less

Ireland’s trade openness is crucial to our economic model, not just to trade but also to people.

central to our offering in the future, but it will still be a lever of competition. This can be achieved through significant simplification of any new regime, rather than layering on top of existing provisions, maximising our world-beating R&D tax credit and other investment supports and ensuring our personal taxation regime remains attractive to high skilled workers.

The evolution of our FDI tax regime When reflecting on both Pillars of the OECD agreement, it is worth reflecting on the road Ireland has come. All told, these changes will not mean the end of the Irish business model but a challenge for us to be better and more competitive. The Irish FDI tax regime has gone through change before. EU membership meant the gradual end of the 0% rate on manufacturing exports which existed from 1956 to 1980. The 10% for manufacturing exporters and the IFSC from 1980 and 1987 respectively were also ended by EU rules. Our current 12.5% headline rate was phased in from 1996 to 2003.

In the past decade, in part because of the BEPS process, Ireland has moved to be a model of substance with extraordinary levels of investment, such that the capital stock in our globalised business model has been transformative. Ireland has arrived at a new level; the challenge is now one of retention of our place as a rich nation as opposed to aspiration. The core reason we continued to thrive despite these changes was radical and concrete action by business and Government. Supporting this action will be core to Ibec’s mission in 2022 and beyond.

Tax will be less central to our offering in the future, but it will still be a lever of competition, which can be achieved through significant simplification of any new regime, maximising our R&D tax credit and other investment supports and ensuring our personal taxation regime remains attractive to high skilled workers.

“We will need to meet this competitiveness challenge by additionally investing in other growth levers. This means scaling public R&D investment, making us a leader for knowledge exchange and intellectual property, prioritising investment in education, skills and critical infrastructure and providing political leadership to prioritise, coordinate and realise Ireland’s digital opportunity at national and EU levels.” 20

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We collaborate with the world for the health of everyone in it With a deep responsibility to the people we serve, we work tirelessly to advance and improve how medicines are discovered, developed and made.

Learn more at www.janssen.com/ireland/


Enterprise Ireland

Supporting Ireland’s biopharma innovators

While multinationals operating in Ireland often get the headlines, we have a thriving indigenous life sciences sector in this country, incorporating numerous high flying pharma and medtech businesses. Doing work that is vital to patients, society and the Irish economy; these firms are innovative to their core. The sector comprises 270 Irish companies, with combined annual sales of €2.4 billion, including exports of €1.9 billion. These companies are flourishing across Ireland, employing more than 10,000 staff, with 65% based outside key cities. That’s completely in line with Enterprise Ireland’s regional development objective, where we seek to drive job creation and impact across the country. To shepherd new companies in this space into commercial viability and to enable existing firms to reach even greater heights, we look to publicly funded research organisations and draw on our in-house expertise to advise, support and connect entrepreneurs, researchers, and industry.

An engine of commercialisation of research Every year, Ireland sees a number of high potential start-ups (HPSUs) emerge from our universities and Institutes of Technology (IoTs). These nascent deep tech firms create high value jobs and go on to generate significant exports.

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Enterprise Ireland’s Commercialisation Fund works to bridge the gap between a really good idea and the point at which a start-up is created that attracts external investors. It gives funding and mentoring to third-level researchers to accelerate the commercialisation of innovative new products and services, and to drive HPSU development. Enterprise Ireland’s Commercialisation Specialists work in close collaboration with Technology Transfer Offices (TTOs) in universities and IoTs. The TTOs are at the forefront of identifying ambitious researchers whose ideas have real market potential. Among the projects the Fund supported in 2020 were three female-led biopharma candidates, including: • StarMAT Technologies, which aims to improve delivery of biotherapeutic drugs, led by Professor Sally Ann Cryan of the Royal College of Surgeons in Ireland; • Vaccine innovators Adjuvenate, led by Associate Professor Aisling Dunne of Trinity College Dublin (TCD); • A project developing gene therapies for age-related macular degeneration, led by Professor Jane Farrar, also of TCD. Not only do biopharma projects like these get an average of €500,000 in public funding over two to three years, but they also get access to a team of Enterprise Ireland commercialisation specialists who provide them with mentoring

Enterprise Ireland can help Irish biopharma companies to access innovation supports to start, grow and scale up, writes Deirdre Glenn, Head of Life Sciences at Enterprise Ireland. and guidance, along with introductions to business partners, potential investors and consultants. Throughout, the commercialisation specialists work to help the project candidates on the journey towards becoming an investable start-up opportunity.

Innovation and research drives revenues As well as enabling researchers to commercialise their ideas, Enterprise Ireland also supports existing companies in Ireland to innovate and conduct research, both on a oneto-one and a one-to-many basis. This activity leads to dramatic results for those of our clients who receive the full spectrum of research and development supports, and who collaborate with third-level institutions. In 2019, those companies saw their revenues quadruple and their exports increase eightfold, by comparison with companies that did not avail of any supports to engage in research, Irish PharmaChem | Industry Buyers Guide 2022


Enterprise Ireland development and innovation. By contrast, those that did little or no research saw only a slight increase in revenue.

Driving innovation with existing companies Enterprise Ireland runs a number of programmes to support existing Irish businesses to access publicly-funded research, with the Innovation Partnership Programme among them. Through this programme, we fund research and development within universities and IoTs on behalf of companies. This is a popular programme for both MNCs and SMEs within the Irish industry, including many Irish biopharma companies, who work with third level researchers to solve a challenge they’re facing. ONK Therapeutics, for example, is a Galway company developing cancer treatments that use enhanced natural killer cells in the immune system to target cancers. It has been funded to work with a TCD team led by Dr David Finlay, Associate Professor in Immunometabolism, to make these cells more effective.

Connecting with third-level innovation expertise When it comes to near-to-market research and innovation, we offer companies access to the Technology Gateway network, which consists of 16 specialised centres of excellence (or “gateways”) across Ireland. These sector-specific gateways connect businesses with innovation expertise within IoTs and technological universities. Among those of particular interest to biopharma firms is the PMBRC Gateway, based in Waterford Institute of Technology, which delivers industry solutions for the pharmaceuticals, medical device, food, ingredients, veterinary, ceramics, metallurgy and engineering sectors. Meanwhile, the Shannon ABC Gateway is a leader in applied biotechnology and bioresource research. It’s based on the Munster Technological University Kerry and

Ireland has a thriving indigenous life sciences sector, incorporating numerous high flying pharma and medtech businesses. Technological University of the Shannon: Midlands Midwest campuses. The CAPPA Gateway, based in MTU Cork, applies light-based photonic technologies for near-to-market problems for industrial partners. It recently collaborated with Irish firm Hooke Bio, which develops technology for use in the preclinical to early stages of drug discovery, on ultra-high-throughput microfluidic screening. This will be of interest to those developing personalised medicine

Funding disruptive technology While Enterprise Ireland does not directly fund gateway projects, it does administer the Disruptive Technologies Innovation Fund (DTIF), which is frequently used a source of funding for companies collaborating with the gateways and other public research providers. Hooke Bio and CAPPA, for example, were funded to the tune of €1.9 million for the research outlined above. For a pre-commercial company facing a complex and expensive route to market, this funding was critical. That process is being mirrored across the economy as the €500 million Government-

Enterprise Ireland’s Commercialisation Fund works to bridge the gap between a really good idea and the point at which a start-up is created that attracts external investors.

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backed DTIF helps to drive collaboration between Ireland’s world-class research base and industry, as they seek to develop and deploy disruptive and innovative technologies. Recently, HiTech Health, along with its consortium partners Relevium Medical and NUIG, were awarded €7 million to develop a complete regenerative treatment for knee osteoarthritis using a hydrogel-based therapeutic.

Reaching many innovative businesses A significant number of Irish SMEs are also benefitting from publicly-funded research through the Technology Centre programme. This joint initiative between Enterprise Ireland and IDA Ireland allows clusters of companies to work together around their innovation agenda. Centres of particular importance to the biopharma industry include the Pharmaceutical Manufacturing Technology Centre (PMTC) addressing pharma advanced manufacturing issues, the CeADAR centre for applied data analytics and machine intelligence, and the Irish Manufacturing Research (IMR) centre in Mullingar, tasked with helping to make Ireland a world leader in advanced manufacturing operations.

Poised for a strong future While the past 18 months have been extraordinarily difficult and the economy has undergone a significant shock, Irish biopharma companies have shown resilience and solidarity backed by really good science and innovation. While there is still uncertainty ahead for Government, society and businesses, publicly-funded research continues to enable Irish businesses to remain competitive, be customer-led and be solution providers in the global marketplace. To find out more about how Enterprise Ireland can help you and your business, visit www.Enterprise-Ireland.com.

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NIBRT

Preparing Ireland Inc. for future success Ireland has established itself as a global leader in biopharmaceutical manufacturing and has had tremendous success in attracting multinational companies to establish manufacturing operations across the country.

2021 saw the world still experiencing the significant impacts of the Covid-19 pandemic in a multitude of ways, from personal health, to public health, to the broader negative effects on society and on the economy. Nonetheless, 2021 was also a year of recovery and hope, with a range of vaccines and new therapies for Covid-19 now emerging and countries racing to vaccinate as many of their citizens as quickly as possible. Many of the successful vaccine candidates, from viral vector-based to novel recombinant protein to mRNA technology, incorporate innovative biopharmaceutical concepts and manufacturing processes. It is felt by many analysts that the Covid-19 pandemic will be seen to have accelerated the development, licencing and uptake of the next wave of biopharma innovation in the Advanced Therapy Medicinal Products (or ATMPs); a category that also comprises the cell-based therapies (i.e., allogeneic, autologous, non-gene-modified and gene-modified) and the gene-based therapies (i.e., viral-vector and non-viral).

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Darrin Morrissey, CEO, NIBRT, advises on how Ireland can catch the next wave of advances in biopharmaceuticals.

Ireland’s global biopharma reputation – a solid foundation for future growth

manufacturing operations across the country. Since 2009, biopharmaceutical foreign direct investment (FDI) has topped €10 billion, with the number of biopharma manufacturing facilities having grown steadily to over 25 by the end of 2020. Over 30,000 people are now directly employed in the sector, which contributes over €40 billion in national exports annually (Source: www.idaireland.com/doing-business-here/ industry-sectors/bio-pharmaceuticals).

Over the last 15 years, Ireland has established itself as a global leader in biopharmaceutical manufacturing and has had tremendous success in attracting multinational companies to establish

Given its previous success in biopharma, Ireland clearly has much of the required expertise and infrastructure - including facilities, experienced workforce, supply chain, cost benefits, etc -

Even without this accelerant effect, there has been dramatic growth in the number of ATMP clinical trials and in the level of ATMP commercial activity in recent years. It was widely predicted that advanced products would be the main biopharma growth driver over the next decade, and this prediction is now all the more certain.

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NIBRT

to build a global leadership position in ATMP manufacturing. However, there is more that can be done to ensure success. The Cell & Gene Therapy (CGT) Forum, established in 2018, pulled together a range of stakeholders with interests in the advanced therapeutics area, including MNC and SME companies, engineering firms, consultancies, academic researchers, representative bodies (like BPCI and IPHA) and government agencies (like IDA Ireland, Science Foundation Ireland, Enterprise Ireland and the Health Research Board). In its first phase activity, the CGT Forum published a white paper in 2019 that recommended four action areas for the accelerated development of Ireland’s ATMP manufacturing ecosystem, including: Talent development: The provision of national higher and further educational supports to ensure biopharma companies can source highly trained staff for ATMP manufacturing operations. Research excellence: Ensuring strong supports for scientific and engineering research in ATMP manufacturing within the broader Irish research system. Infrastructure: Provision of the necessary infrastructural investments in ATMP manufacturing and development, including scale-up facilities, testbeds, incubators, training facilities, etc.

Irish PharmaChem | Industry Buyers Guide 2022

Public-Private sector alignment: Ensuring a joined-up approach across government, state agencies and companies to advance the ATMP sector. Significant progress has been made in 2021 across each of these four recommendation areas: ATMP manufacturing skills and talent development The CGT Forum has established a ‘Training and Education’ working group to set direction and drive action in ATMP manufacturing skills development. This group, with representatives from the higher and further education institutes, MNCs and SMEs, has developed a comprehensive set of priorities focused on developing, (1) specific ATMP-related technical skills and (2) more generic yet very important transferrable skills, including process and analytical performance monitoring, logistics and cold-chain management. With these priorities set, many of Ireland’s higher educational institutions are now developing tailored programmes to address them. NIBRT in particular, as Ireland’s primary training institute for biopharma manufacturing, has launched a number of ATMP training programmes during 2020/21, including: ● An Introduction to ATMPs/CGT: 2-day blended course. ● Advanced Cell Therapy Manufacture: 3-day blended course, in collaboration with Cytiva. ● Fundamentals of Stem Cell Manufacture: 4-day blended course, with the Centre for Cell Manufacturing (CCMI), Galway.

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NIBRT 2021 saw a significant increase in state and above-state funding flowing into ATMP manufacturing research.

● Introduction to Gene Therapy Manufacturing: 2-day blended course. ● Manufacture of Viral Vectors: 3-day blended course. ● NIBRT Online Academy modules: Vaccine manufacturing; Cell therapy; Gene therapy. ● Immersive Biopharma 4.0 courses, aimed at improved data usage and uptake of technology and automation in advanced biopharma facilities.

Research and Development in ATMPs ATMPs are complex and their manufacture and supply, as exemplified in the early days of the Covid-19 vaccine roll-out, present unique challenges for manufacturing companies. Similar to the comparability and yield challenges experienced with monoclonal antibody manufacturing in the 1980s, the highly diverse range of ATMPs are already experiencing scaling, consistency, safety and affordability challenges. Therefore, the ability of the industry to access research skills and expertise close to their sites of manufacture, with the capacity to address process development, analytics and manufacturability issues, will be critically important for the future. The CGT Forum is now focused on identifying the top manufacturing challenges associated with ATMP manufacturing and identifying where Ireland has complementary research strengths and skills across the academic and private sector research base to address these challenges. The ultimate aim is to produce an online directory of researchers and infrastructures in Ireland into which the global biopharma industry can seamlessly tap, while availing of co-funding research supports from the state. Notably, 2021 saw a significant increase in state and above-state funding flowing into ATMP manufacturing research. The third round of Disruptive Technology Innovation Fund (DTIF) awards, announced in April, resulted in funding with a combined value of over €20 million, from a total funding pot of €95 million, being awarded to five ATMP-related projects, involving indigenous Irish ATMP-oriented companies, like Remedy Biologics, aCGT Vector, Valitacell, Avectas and BlueBridge Technologies, partnering with Irish HEIs and research institutes, including NIBRT. Meanwhile on the European front, the European Innovation Council (EIC) recently ran a CGT manufacturing-themed Pathfinder Challenge call which is scheduled to make funding awards in the first half of 2022.

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Investment in ATMP manufacturing and development infrastructure NIBRT is currently awaiting planning for an expansion of its Dublin facility, scheduled to commence in early 2022 and for completion in early 2023. This expansion, which is funded by a capital investment from IDA Ireland / the Government of Ireland of €21 million over five years, will create 1,600m2 of additional space, including an extra five laboratories and two new training suites, wholly dedicated to ATMP manufacturing. NIBRT is currently hiring additional principal investigators for its research team, to arrive during 2022, while hiring of additional trainers will kickoff later in the new year. In the private sector, a number of large-scale ATMP investments have also been announced during 2021, including: ● Meira GTx’s announcement of Shannon as the site of its new cGMP viral vector manufacturing facility and cGMP plasmid production facility. The facilities will produce commercial-grade gene therapies in a fully integrated manner, creating 100 new jobs, with many of these staff trained at NIBRT. ● Takeda’s €36 million expansion at its Grange Castle facility to support expansion of its cell therapy capacity: with the creation of approximately 100 new jobs over three years. ● Pfizer’s expansion of its Grange Castle facility to the manufacture the Pfizer-BioNTech Covid-19 mRNA vaccine, with the addition of 75 new jobs.

APC Pharma’s €25 million investment in a new global centre of excellence to accelerate the development and manufacture of Covid vaccines and other medicines, as well as its €17 million spin-out of a CGT contract manufacturing company VLE Therapeutics.

Joined-up ATMP approach across government, state agencies and companies The work of the CGT Forum has already demonstrated the tremendous alignment that can happen between the state and private sector when there is a concerted effort to tackle an area of national strategic importance. In parallel, the Irish Pharmaceutical Healthcare Association (IPHA), with PwC, has done some great work on the patient access challenges associated with the growth in innovative medicines and vaccines, while BioPharmaChem Ireland (BPCI) and EY have established a working group that is exploring the digital and business services opportunities associated with advanced therapies.

In conclusion As we look forward to the next decade, the manufacture of Advanced Therapy Medicinal Products (ATMPs) for the supply of global markets, including cell and gene-based medicines, oligonucleotide-based therapeutics, and novelmodality vaccines, represents a major opportunity for Ireland. NIBRT is committed to playing a leading role, along with our partners at IDA Ireland and other state agencies, with MNC and SME industry players and with all stakeholders, in enabling Ireland to capitalise on this opportunity. Irish PharmaChem | Industry Buyers Guide 2022



Supply Chain

The importance of being vigilant in a post-Brexit world Enda Dempsey, BioPharmaChem Ireland.

Enda Dempsey, BioPharmaChem Ireland, examines the continuing impact of Brexit on the pharmaceutical supply chain, and why it may prove Ireland Inc.’s greatest challenge going forward. It was the day the earth stood still… Almost. At 12am, on January 1, 2000, the muchpublicised Y2K bug was finally unleashed upon the world and then vanished from the collective consciousness almost as quickly as it stormed into it. Today, it is thought of at worst as a complete hoax and at best, an overblown techno-panic. However, the forgotten truth is that the US alone spent $100 billion over five years developing code fixes for the myriad of computers and other electronic devices available at the time. Even still, there were serious incidents in nuclear power plants, satellite communication uplinks and banks across the globe. In 2016, the United Kingdom (UK) voted to leave the European Union (EU) in a move which was deemed by many business experts as a catastrophic mistake which would imminently collapse their economy and bring about decades of hardship. Five years later, most of these predictions are unrealised and are mockingly grouped together under the pessimistic ‘Project Fear’ umbrella. However, Brexit had a very real impact on the biopharmaceutical industry, requiring it to retool its operations and plan strategically for several years ahead, but closer to home, it remains a looming existential threat to the vibrant Irish industry. Unlike the Y2K bug, Brexit

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will not simply vanish at the stroke of midnight; in fact, that’s precisely when it began in earnest.

sparking an immediate flashpoint, forcing the EU to relax their policy on this demand. Undoubtedly, over the next decade, there will be substantial text revisions but until then, it is worth exploring what was done to prepare for this eventuality, how it is playing out and what the knock-on effects are.

The show must go on

Fail to prepare, prepare to fail

Inevitably, Article 50 was triggered, and the UK formally announced that they would be leaving the EU trading bloc after 47 years of membership. Following taut negotiations amidst febrile political goodwill, two major treaties were eventually signed: the Withdrawal Agreement, including the Protocol on Ireland and Northern Ireland, and the EU-UK Trade and Cooperation Agreement (EU-UK TCA). These treaties were fundamental in staving off the worst outcomes of a cliff-edge Brexit but already cracks have been appearing and new battle lines have been drawn. Perhaps the biggest success from these agreements was that they effectively eliminated the placement of tariffs and quotas on bilateral movements of each other’s goods, although it stopped short of a mutual recognition of GMP inspections. The UK has also made some unilateral decisions such as temporarily disapplying import checks on EU goods until 2022 at the earliest, as they are not yet in a position to manage them. This was not reciprocated and in Northern Ireland for example, sanitary and phytosanitary (SPS) inspections were required,

The UK government and the biopharmaceutical industry devised several different strategies to smoothen the transition period for Brexit. One of the first key challenges the industry identified was future delays caused by customs and border checks. To mitigate against this, freight forwarders and other logistical solution providers obtained the Authorised Economic Operator (AEO) or ‘trusted trader’ status for the EU. This is a globally recognised, voluntary programme established by the EU in 2008 which enhances the security procedures for international cargo transportation. While not a panacea for the new Brexit controls, the AEO status granted certified exporters a simplification of procedures, priority treatment and lower examination rates on goods, permitting them to be fast-tracked at the point of import/export. Furthermore, it is recognised in other major markets such as Japan, the US, and China. In August 2020, the UK government urged wholesalers to stockpile six weeks’ worth of drugs to act as a buffer against unexpected shocks rippling out from the end of the transition period, as the UK imports 90% of Irish PharmaChem | Industry Buyers Guide 2022

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Supply Chain

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Irish PharmaChem | Industry Buyers Guide 2022


Supply Chain

Brexit was the topic du jour for the European community, until it was completely overshadowed by the emergence of the Covid-19 virus. its medicines, 45% from the EU. In fact, most biopharmaceutical manufacturers had already built up their own stocks where possible. This approach was not viable for all products for several reasons; limited shelf-life, current manufacturing capacity being maxed out with no excess production available, and the risk of tying up a significant amount of capital in an illiquid asset. Other dedicated measures taken by the UK government included passing a new law called the Serious Shortage Protocols, which among other effects permits pharmacists to prescribe interchangeable drugs to patients and awards contracts to ferry companies to deliver critical medicines to smaller ports, with the intention being to bypass any potential backlogs. As a result of the above measures, the UK has not seen the anticipated medicine shortages. However, the customs checks required by the EU for imports from Great Britain (GB) have significantly reduced the volumes to other countries. In Ireland, the percentage share per tonne of imports coming from GB has slumped from 21% in 2019 to 11% in 2021 (based on the first six months of data). This figure is even more dramatic for other EU countries such as France and Portugal, which have seen import declines between 22% and 55% respectively. It is likely that these reduced volumes will be sustained as global businesses, biopharmaceuticals included, realign their supply networks. In fact, new shipping routes between Rosslare and Cherbourg were opened to accommodate the need to avoid the GB landbridge entirely, even though the full travel time takes approximately 48 hours, compared to 20 hours via road. This route alone has seen a 45% growth in volume since the beginning

Irish PharmaChem | Industry Buyers Guide 2022

of 2021, while haulage trucks through GB have dropped by 50%. Overall, these trends coincide with the expected movement of distribution hubs out of the UK to other continental countries, particularly the Netherlands, and for new transportation routes to be developed entirely. The European Medicines Agency (EMA) was forthright in its assertion that biopharmaceutical manufacturing operations would need to be conducted on EU/EEA sovereign territory with the exception of Northern Ireland, if import checks were to be avoided, effectively treating GB as a third country. In the intervening period, numerous detailed Q&A documents were published, addressing how the Manufacturing Authorisation Holders (MAHs) would need to relocate, along with employees in critical roles, such as the Qualified and Responsible Person. Conversely, the sale of medicinal products into the UK will require new positions to be established, namely the Responsible Person (import). Fortunately, there was a lead-in time of several years, which greatly reduced the impact of these Brexit changes.

The devil is in the detail Despite the preparations completed by all parties involved, the UK leaving the single market has consequences, most of which will seep out over time to a lesser or greater effect. Immediately though, the Rules of Origin for goods have created an additional expense for companies doing business with the UK. It has been confirmed that the EU-UK TCA will provide full bilateral cumulation but no cumulation with any third country (diagonal cumulation). In other words, goods brought into the UK from Japan and then sold on to an EU country will be subject to tariffs, despite existing trade agreements between the EU and Japan. A number of clauses are in place that can mitigate these costs though. If products undergo a substantial transformation such as processing or are limited in quantity, they may be exempt. However, any goods exported from either the EU or a third country to Britain (which are not held under customs controls) and then are subsequently re-exported to the EU will incur tariffs. This principle also applies to goods moving from Britain to the EU and back to Britain. These provisions mean that distribution hubs in Britain must act, for example, as customs warehouses, if they wish to continue to move

goods through their centres and onwards to the EU. More costs of moving goods through the GB landbridge include the requirement for bonded warehouses/trucks to act as insurance for loss or theft also.

Schrödinger regulations Another hugely contentious issue remains how Northern Ireland will be regulated in the future too. The Protocol on Ireland and Northern Ireland gave a special dispensation to this territory to prevent the need for border checks on the island of Ireland. While it is not legally possible for either party (UK or EU) to unilaterally disapply the entire Protocol, Article 16 can be used unilaterally to disqualify certain specific rules if they “lead to serious economic, societal or environmental difficulties that are liable to persist, or to diversion of trade”. This could lead to a renegotiation of specific parts of the treaty under the various Articles contained within the Withdrawal Agreement and the EU-UK TCA, with the European Court of Justice also having a role as a mediator. Ultimately though, the Northern Ireland Assembly can vote to leave this Protocol through Article 18 in 2024. While some disagreements are currently being voiced, the most immediate concern is the erosion of business confidence, particularly if it leads to inhibitory trade practices or worse still, the dissolution of the treaty completely.

Another ‘Black Swan’ event Until recently, Brexit was the topic du jour for the European community. That was until it was completely overshadowed by the emergence of the Covid-19 virus and the subsequent fallout, which has completely upended businesses across the globe, temporarily knocking it out of the spotlight. Among the many challenges it has created, perhaps the biggest impact for Irish industry has been the severely curtailed air freight. More than 50% of biopharmaceuticals are transported out of Ireland via air to distribution hubs on the continent. However, due to the worldwide travel ban, up to 95% of the total commercial aircraft were grounded as passengers are critical in offsetting the cost of cargo transport. Furthermore, wide-bodied airplanes (pallet friendly) are being phased out in favour of the narrow-bodied (reduced cargo capacity) as they are more economical to run. Combined, the price per kg per km has increased exponentially. Alternative

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Supply Chain

The EU is exploring the feasibility of re-shoring Active Pharmaceutical Ingredients to its territory, potentially opening up new opportunities to attract businesses here. transportation networks are not always viable as the sea routes can be too long and the GB landbridge is becoming increasingly unpredictable, especially due to the impending customs controls. In fact, this pandemic has exposed probably the greatest vulnerability of Ireland, its geographical isolation to the rest of the continent. While short-term countermeasures can be enacted, notably by paying excess fares to ensure the products are a priority on the flights, in the long run, Ireland as a location for inward investment may be put under the microscope.

Fitter, stronger, faster Ireland has weathered many storms in the past, but Brexit may yet be our greatest challenge as our close ally transitions into a keen competitor. This will be especially true for attraction and retention of the biopharma industry, so strengthening our connectivity to the rest of Europe will be key. England’s East Midlands Airport is the UK’s busiest cargo-only airport and it saw a 26% spike in traffic during 2020. This may serve as a useful case study for upgrading our own infrastructure, as the demand for cargo flights is set to increase due to the Brexit fallout. SingleUse Systems have fallen into such short supply, the EMA have just requested the industry to provide feedback on the risks and impacts it will have on their manufacturing operations. In fact, there has been a dearth of material up and down the supply chain. This is partially due to the unprecedented demand caused by Covid-19, but it is also a reflection of their business models’ ‘Just-in-Time’ stock, plus long,

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complex global supply chains. This has prompted the EU to explore the feasibility of re-shoring Active Pharmaceutical Ingredients to its territory, potentially opening up new opportunities to attract businesses here. Finally, for Ireland to maintain its green image, it needs to embed green policies into future investments as the latest point for Factory 5.0 is sustainability.

Success breeds complacency While the Y2K bug may be a distant memory, the fallout from Brexit will continue to rumble on, even beyond the Covid-19 pandemic. For the industry as a whole, it will be a costly inconvenience but one that will eventually be absorbed into doing business in a global economy.

For Ireland, though, the loss will be much more acute, as companies here lose their unimpeded access to their oldest and closest trading partner, one which we are inextricably linked. The effects will be much more long lasting and unless we continue to plan ahead and invest in the industry we currently have, it could erode away beneath our feet. Whilst the famous philosopher and free thinker, Homer once questioned the need to prepare in the absence of an immediate threat, a viewpoint that is unfortunately becoming all too common, this is not a risk we can afford to take now or ever. “Marge, why are we buying Maggie vaccinations for diseases she doesn’t even have?”

Global businesses, biopharmaceuticals included, continue to realign their supply networks in the wake of Brexit. Irish PharmaChem | Industry Buyers Guide 2022


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Regulation

Supporting Ireland’s pandemic response The Health Products Regulatory Authority has provided expert regulatory support during the Covid-19 pandemic, writes Dr Lorraine Nolan, CEO, HPRA, including the development and delivery of a joint regulator-industry workshop focused on enabling manufacturing capacity.

Supporting the national pandemic response from a regulatory perspective has been, and continues to be, a primary focus for the HPRA. Throughout 2021, the organisation provided expert regulatory support to colleagues from across multiple levels of government responsible for health service delivery, in addition to sustained engagement with healthcare professionals, the biopharmacuetical industry and patients. As the national vaccination campaign progressed, the HPRA initiated an extensive monitoring programme to closely assess the safety, and ultimately the benefit-risk profile, of each authorised vaccine, together with other regulatory partners from across Europe. Thanks to the massive collaborative effort at national level by government, the health system, policymakers, the broader public and private sector, community groups and people all across the country, Ireland has been able to achieve some of the highest rates of vaccination globally, which has undoubtedly contributed to saving many lives.

Collaboration and partnership The importance of collaboration and partnership to ensure the continued manufacturing and supply of critical

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Dr Lorraine Nolan, CEO, HPRA.

medicines throughout the year was also an essential aspect of the national pandemic response. Together with the biopharmacuetical industry, regulators worked to implement a range of flexibilities to help companies maintain regulatory compliance and avoid shortage issues. Remote inspections were one of the adapted regulatory flexibilities utilised by the HPRA, having decided to suspend on-site inspections in March 2020. The HPRA, in fact, were lead developers of European guidelines on remote and distant inspections. We are now starting to see, however, the gradual reintroduction of some on-site inspection activities, including the area of blood tissues and organs, and some GMP and GDP inspections. Further increases in on-site activities are expected in 2022, subject to contemporaneous public health guidance. While remote inspections might not

fully compensate for all aspects of on-site activities, the pandemic has afforded the opportunity to consider the use of remote elements to complement on-site activities in specific situations. For example, hybrid inspections may be utilised in certain cases where on-site inspection teams are virtually supported by colleagues using remote assessment approaches. Remote/hybrid type inspection activities will continue to be an evolving area over the coming months and years, not only nationally, but also at a global level.

Joint regulator/industry workshop Recently, the HPRA, in collaboration with colleagues from the European Medicines Agency (EMA), US Food and Drug Administration (FDA), and representatives from the biopharmaceutical manufacturing sector, were heavily involved in the development and delivery of a joint Irish PharmaChem | Industry Buyers Guide 2022


Regulation

s

multiple international regulatory agencies utilising desk-based inspection activities, combined with on-site activities performed by the regulatory agency of the host country where the facility is located. The outcome from this pilot will further identify differences, and potential areas for alignment and harmonisation of regulatory requirements across regions, leading to more effective and efficient inspection activities over time.

Strategic direction and leadership in Europe

regulator-industry workshop focused on enabling manufacturing capacity during the pandemic. As outlined in the workshop report (Source: ICMRA-Industry Virtual Workshop Report on Enabling Manufacturing Capacity in the Covid-19 Pandemic), a primary aim was for regulators to better understand the challenges faced by manufacturers seeking to increase manufacturing capacity for Covid-19 therapeutics and vaccines. The workshop also provided a forum to identify opportunities for further collaboration to enable a more effective global regulatory response to the current and future public health emergencies. As a direct outcome from the workshop, efforts are underway to develop an international pilot project focusing on collaborative distant/remote inspection, combined with local on-site GMP inspection activities. Specifically, the pilot will employ a collaborative ‘hybrid’ approach involving Irish PharmaChem | Industry Buyers Guide 2022

In addition to our role in the national Covid-19 pandemic response, the HPRA has also contributed to a range of activities at European level, not least of all through the provision of strategic direction and leadership within the European Medicines Regulatory Network (EMRN). Moreover, representatives from across the organisation have expertly contributed to various pandemic preparedness activities through EMA scientific committees, task forces and working groups, in addition to our involvement in EMA scientific assessment of Covid-19 therapeutics and vaccines. The organisation will continue to engage and influence medicines regulation at European level throughout 2022 as evidenced by the recent appointment of HPRA colleagues to prominent European positions, including, Dr Séan Barry from the Human Products Authorisation and Regulatory (HPAR) Department, who was recently elected to the position of Co-Chair of the European Biologics Working Party.

Changing leadership team During 2021, there has also been significant change in our senior leadership team due to several retirements, and I would like to take

this opportunity to express my sincere thanks to John Lynch, who recently retired as our Director of Compliance, having first been appointed as Director of Inspections in 1996. John leaves behind an incredible legacy in the strength of the Compliance Department and the standing that it has today across all the areas of its remit in both public and animal health protection. The Department is in good hands, however, as Gráinne Power has been appointed as the new Director for Compliance. Gráinne brings a wealth of knowledge and experience, both from her previous roles in industry and during her time as Director of HPAR, and she is well positioned to lead the Compliance Department into the future.

Remaining vigilant It has been an incredibly difficult period for many reasons, but thanks to the dedication of so many actors across society, we are certainly in a different position at the end of 2021 compared to last year. The authorisation of safe and effective vaccines, combined with incredible rates of uptake in Ireland and continuation of nonpharmaceutical interventions, has helped to protect our communities. We must remain vigilant in our approach, however, as further efforts are required to ensure the continued protection of society, particularly those most vulnerable. The pandemic response continues to demonstrate the value of an effective and agile regulatory system, combined with close collaborative engagement with key stakeholders. This collaborative and agile approach is especially important as the HPRA works towards the ambitious goals and objectives outlined in our new strategic plan.

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Should you wish to be part of our team in the manufacture of high-quality, affordable medicines, please see all our job openings on the Careers section of our website

www.amneal.com


Digital Health The Covid-19 pandemic has highlighted the need for a more connected approach to healthcare and has accelerated the adoption of digital health solutions across health systems, resulting in greater collaboration between industry, clinicians and regulators. Ireland is home to approximately 200 companies engaging in digital health, alongside 100+ pharma companies, 450+ medtech companies and 900+ tech companies. Ibec, Ireland’s largest lobby and business representative group, has brought together the Irish Medtech Association, Technology Ireland and BioPharmaChem Ireland for a cross-sectoral campaign entitled ‘Where Digital Health Thrives’. The aim of the campaign is to make Ireland the location of choice to develop, launch and adopt transformative digital health solutions through the creation of a clear framework for safe data use, integration and sharing, in addition to encouraging the health system transition to digital. Attraction and development of mobile talent to create, deploy and adopt digital health solutions and services, as well as the development of a clear regulatory pathway for digital solutions and services, are key to developing Ireland as the location of choice in the digital health space. The vision is “To enable Ireland to become a recognised global hub for digital health, where companies can develop and commercialise products, as well as attract projects and investments.”

A digital approach to healthcare Nessa Fennelly, Senior Executive, BioPharmaChem Ireland, explains the thinking behind the cross-sectoral ‘Where Digital Health Thrives’ campaign, and explains some of the potential benefits of adopting a digital approach to healthcare for patients and professionals.

Matt Moran, Director of BioPharmaChem Ireland, reveals that as an association, BPCI aims to further the digital health industry to benefit society at large. “It melds together monitoring biomarkers within the body with therapy to help the patient have a better outcome,” Matt explains. “Sick patients use virtual tools to speak to a doctor to get better, and people are using these tools to make sure they don’t get sick in the first place. “We already have many examples of how this collaboration is working,” Matt continues. “Diabetes is one of the areas where digital health can be especially useful, as it needs to be constantly monitored. We have seen digital health tools such as glucose monitoring tools. This sees every one of the three industries come together to solve an issue for patients. That level of engagement is why Ireland is a great place for digital health to progress even further.” In fact, Matt envisions many more digital health products and services emerging here: “To have them commercialised and made in Ireland will help the industry and economy going forward.” Matt believes that not only will the patient benefit from the use of digital health, but the country as a whole will also benefit from being engaged in this next wave of digital Irish PharmaChem | Industry Buyers Guide 2022

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Digital Health

Ireland Where Digital Health Thrives

An Ibec Campaign

The ‘Where Digital Health Thrives’ campaign was launched jointly by Ibec’s Irish MedTech Association, BioPharmaChem Ireland and Technology Ireland. therapeutics. “There are challenges to bringing together the three different industry sectors of biopharma, medtech and tech, along with the burgeoning digital health sector,” he notes. “But in Ibec, we have representative bodies for these industries all under one roof. This helps with collaboration between them all and the Ibec Digital Health Working Group is bringing leaders and experts together to develop the business supports and shape policies for success. “The ‘Where Digital Health Thrives’ campaign is the organisation’s first cross-sectoral initiative of its kind and we see great opportunity to use this approach to deliver results that matter to members.” Innovations in digital health have been emerging in Ireland for many years, but the demand has been accelerated under Covid-19, with technologies such as remote diagnosis, data insights and connected devices supporting care delivery in and out of the hospital. As we look to the future, digital health products and solutions can help ensure more sustainable health system models that improve outcomes while reducing costs. Greater technology adoption in hospitals, as well as by health care professionals and patients, will be essential to reap the benefits of this dynamic industry. New technology needs to solve a real problem. Digital health drives better decision making by health care professionals by allowing them to identify risk, monitor and track disease progression. For the public, it can not only support better patient adherence

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to care, but also promote a preventative approach to healthcare. This has proven to be particularly important for tackling heart disease and chronic conditions. With an established ecosystem of large foreign multinationals and mobile talent already here, more international investors see Irish start-ups as a safe bet for digital health success. Lorcan Walsh, Director of Data Science and ad interim Digital Solution Director for Digital Endpoints at the Novartis Global Service Centre in Dublin, asserts, “We are a data rich and data-driven business. For example, over the past two decades we’ve collected two million patient years of data from our clinical trials. Beyond clinical trials and when patients are using our therapies in clinical practice, we continue to monitor for effectiveness and safety.” However, with new scientific advances in recent years, the ability to analyse huge amounts of data in new ways has become significant, offering new opportunities to improve human health. Lorcan explains that this is why the company is aiming to “reimagine medicine” and adapt the way data is collected and interpreted. “To reimagine medicine, we need to reimagine the way we work,” he notes. “This involves combining digital and data, so that we can measure patients better within our clinical trials, reduce the medicine development timeline, and get better therapies to patients faster. “Digital can also help us collect novel insights in patients’ lives to build a better chain of evidence to advance our therapies, reduce patient burden and shorten trial durations,” Lorcan continues. “For example, currently within our trials, we collect data including different devices, such as X-rays, biosamples, and information from patients themselves encompassing how a patient feels, functions, or survives. Digital solutions, such as wearable sensors or at-home surveys, are showing more and more potential to gather more sensitive measures and can be gathered at home, potentially reducing the need for patients to visit the clinic.” The pharmaceutical industry in Ireland is reimagining medicine with digital health. Digital health is not only leading to a better understanding of how medicines are developed and used; data is helping gather insights from clinical trials to develop better drugs, faster, while ensuring that patients better understand their medication and can adhere to it more easily. The availability of a highly educated workforce, as well as the presence of leading companies from key sectors, such as medtech and tech, makes Ireland a location of choice for pharmaceutical businesses developing digital health.

Ibec digital health strategic pillars 1 Build awareness of the value of digital health products and solutions

2 Represent the digital health sector

3 Deliver industry foresight to members

4 Support the evelopment of a world class talent pool for the digital health sector

5 Build partnerships in the digital health sector

Irish PharmaChem | Industry Buyers Guide 2022


We have operated in Ireland for more than 80 years bringing innovative medicines to patients and consumers to improve health and wellbeing. Our Dublin headquarters is home to our Pharmaceuticals and Consumer Healthcare business. Our Pharma business is one of the largest providers of vaccines to the Health Service Executive and all vaccinated babies in Ireland receive at least one GSK vaccine, while our Consumer Healthcare business is a leader in oral care and pain relief in Ireland. Our Dungarvan manufacturing site started operations in 1981 and produces 8.2 billion Panadol products a year for export to over 70 markets worldwide. And at our Cork hub, we have staff working in a variety of global roles within GSK.


Disruptive Technology

Shining a light on disruptive technology

A host of companies have come together to form a lighthouse partnership in disruptive technology to address the digital and sustainable transformation of the Irish small molecule manufacturing sector in terms of digital capabilities, sustainability and Industry 5.0, writes Bryan O’Donnell, Partnership and External Supply Ireland Hub Lead, Janssen. 40

Irish PharmaChem | Industry Buyers Guide 2022


Disruptive Technology From a societal perspective, drug development is a high investment, high duration, and complex process. Recent reports estimate that the average time required to bring a single drug to the market is 12 years at a cost of US$1.2 billion. Combined with the pressure to re-coup costs within the period of patent exclusivity, the pharmaceutical industry is under significant pressure to accelerate innovation and to reduce the cost and time to bring new products to the patients that it serves. In response to this, the pharmaceutical industry is strategically looking to where new emerging technologies can address these challenges and ultimately bring more affordable drugs to those most in need. Small Molecule (SM) based drugs are currently experiencing a revival due to advances in molecular biology, high throughput screening and innovative ways to identify new drug targets and drugs (artificial intelligence). The global demand for oral solid dose (SM drugs) continues to grow. With that, the opportunity exists in how to deliver this strategic initiative, which was the basis and purpose of bringing together several companies from both within and outside the pharmaceutical sector to address this challenge. These companies set out to address the digital and sustainable transformation of Irish small molecule manufacturing and the associated supply chain to achieve digital capabilities and green sustainability targets, and to leverage capacity and capabilities found in other Irish sectors (namely technology, advanced engineering and disruptive and emerging digital and sustainable technologies) to achieve project objectives, aligned to the Industry 5.0 strategy.

The challenge: the modernisation of production processes The types of small molecule under development differ to those of old, primarily in terms of volume (high to low), potency (lower-high potency) and complexity (hybrid drug formats, combination drugs). This places new challenges on existing plants to be able to reconfigure manufacturing operations to accommodate new drug formats and emerging needs. Moreover, increased collaborations amongst life sciences sectors (bio, pharma, medtech), nonlife sciences sectors (engineering, technology) and contract manufacturers is envisioned in the future to deliver next generation type products manufactured with next generation platforms (e.g. digitally enabled, robotics). Coupled with the above changes, manufacturing is undergoing a transformation, driven by the emergence of a raft of new production, digital and sustainable technologies (Industry 5.0). The need to reduce their environmental impact is also becoming a critical focus of existing operations, and collectively these trends are necessitating that all sectors look to new ways to continue to deliver existing and new products from pre-existing sites.

Objective: Digital Maturity and Sustainability Assessment As an aid to identifying areas of investment, a Digital Maturity and Sustainability Assessment (DMSA) Irish PharmaChem | Industry Buyers Guide 2022

was conducted by a consortium of companies with the aim of benchmarking current state, identifying best practise exemplars and areas of opportunity and enabling the development of a data rich strategy that considered the unique technological and organisational direction, roadmap, and destination of the consortium members. The assessment examined over 70 key Industry 4.0/5.0 concepts and technologies across the industry value chain and sustainability. Key areas of investment have emerged from this assessment, which will form the basis of a full submission. These include: • Robotic Process Automation to drive improved business intelligence and supply chain resilience; • Deployment of AI and machine learning technologies to drive enterprise and process automation; • Sustained upskilling to support development and growth of workforce 5.0; • Improve resilience and capacity of sustainable energy generation; • Deployment of alternative technology approaches to reduce use of energy intensive steam in manufacturing; • Development of mature industrial AR/VR applications to drive improved compliance/ quality/workforce enhancement; • Advance the application of Cobot technology in small molecule manufacture to improve safety and resilience; • Advance the deployment of continuous manufacturing;

Establishment of 5G networks to support IoT and enable mobility. Many learnings from this initiative will be transferable in the main to many other sectors initially, with the next phase to engage other sectors like biologics, advanced and emerging therapeutics and medical devices and technologies, in successive stages, in collaboration with relevant stakeholders. This initiative will look to address the challenges of the pharma sector through development of an Industry 5.0 ecosystem. This ecosystem will be a collaboration of pharmaceutical companies, both captive and contract manufacturing, as well as non-pharmaceutical companies, agencies, and academic segments. The learnings will also be covered by key industry groups like BioPharmaChem Ireland (BPCI) which is the representative body for the chemical, biopharma, and biotech manufacturing sectors in Ireland. BPCI is an active member of the consortium and prioritises Factory 4.0 and 5.0 in its own industry strategy – ‘Ireland: the Global BioPharmaChem Location of Choice’.

Conclusion Completing the DMSA enables individual companies to complete a data driven approach to how they can advance their Industry 5.0 objectives. This DMSA also enables the industry to identify any collaborative initiatives where both pharmaceutical and non-pharmaceutical companies can collaborate within the Industry 5.0 ecosystem. This enables the ultimate vision of the LPDT group, which is to advance supply chain transformation and enable more innovative solutions for the patient.

About the author: Bryan O’Donnell is the Partnership and External Supply Ireland Hub Lead for Janssen, responsible for partnering with strategic contract manufacturing organisations to create value through collaboration. Janssen is a pharmaceutical company providing medicines for an array of health concerns in several therapeutic areas. Janssen is part of Johnson & Johnson Family of Companies, the world’s most comprehensive and broadly based manufacturer of healthcare products and related services. Bryan has over 25 years’ experience in General Management and Operations Leadership positions across Pharmaceutical, Electronics and Fast Moving Consumer Goods (FMCG) sectors. He earned First Class Honours MSc in Supply Chain Management (UCC). Bryan is an authentic, outcome-driven leader with a track record of successfully delivering in highly compliant and results-driven industries. He brings a diverse experience and skills portfolio, coupled with an emphasis on taking the strategic view in any marketplace.

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Manufacturing in Ireland

Ibec report examines future for manufacturing in Ireland

‘Manufacturing in Ireland - Today, Tomorrow and Beyond’ is an Ibec report which charts the success of the Irish manufacturing sector to date and assesses what needs to happen to help it meet the significant challenges ahead. Ibec recently conducted a survey of its manufacturing member companies to input into a report, ‘Manufacturing in Ireland - Today, Tomorrow and Beyond’, which shines a firm spotlight on the scale of the manufacturing sector in Ireland. The sector spans everything from successful indigenous Irish companies to global companies of huge scale. A sector as diverse as it is strong and resilient, constantly evolving, modernising and adapting to new processes and new markets, manufacturing is one of the high performing engines of the Irish economy “On several fronts, this is shaping up to be a pivotal decade not just for Ireland, but globally,” writes Sharon Higgins, Ibec’s Director of Memberhip & Sectors, in the report. “Having successfully emerged from the economic crash of the noughties, we’ve now encountered a pandemic; the great challenge of climate change; changes to the global tax regime; and, for Ireland and Europe, the challenge of Brexit. In isolation, each of these challenges is great, together, they require even deeper levels of resilience and adaptation. Irish PharmaChem | Industry Buyers Guide 2022

“We believe Ireland is very capable of meeting the challenges head on and with renewed energy. We know the country’s great strength in manufacturing exports – 60% of Ireland’s final manufacturing exports are now part of global supply chains, one of the highest such ratios in the world, and a hugely significant level of our employment is sustained by this global demand. This comes from medtech, technology, pharma and many other product lines. We also know the resilience and innovation from indigenous Irish businesses, manufactured locally and sold globally.”

A model of substance Irish manufacturing today is a model of substance, the report maintains. The pandemic period of 2020 and 2021 has revealed the importance of a strong and resilient manufacturing sector to the Irish economy. During a time when every other country in Europe saw its manufacturing exports fall, Ireland’s grew in 2020. This was driven by Ireland’s strength in key manufacturing sectors and critical products.

That strength provided the revenue flows which helped support the whole economy and society. Overall, there are 260,000 people employed in the Irish manufacturing sector, accounting for over 12% of total employment in the economy. The sector is also responsible for €12.5 billion in wages and employment taxes annually, €1.7 billion of tangible investment and 27%, or over €3 billion, of corporation tax. In addition, it spends, over €19 billion each year on purchases of goods and services from other suppliers in the Irish economy. The story of manufacturing in Ireland is not just one of inward investment, the report stresses, as Irish owned manufacturing exporters grew their sales globally by over 80% between 2010 and 2019, while value-added per person employed grew by 25%. Inward FDI manufacturers grew their exports by 44% over the same period. Irish manufacturers are also outward looking and employ over 150,000 people abroad, including more than 60,000 in the US and 25,000 in the UK.

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Manufacturing in Ireland The evolution of manufacturing The report delves into the history of manufacturing in Ireland, characterised by significant strategic investments in key sectors, paying off over recent decades in a complete transformation of the Irish economy. In 1950, Ireland’s main exports were live cattle, racehorses, fresh eggs, and stout. By 2020, Ireland had become the second biggest exporter of complex pharmaceutical goods and medicines in the EU after Germany – including leading Europe in the export of antisera and immunological products and being Europe’s second largest exporter of vaccines. It was also the second largest exporter of medical devices in Europe, and the continent’s largest exporter of contact lenses, test kits and diagnostics, pacemakers and the second biggest for the export of orthopaedic products. In addition, 60% of Ireland’s final manufacturing exports are now part of global supply chains, one of the highest such ratios in the world. According to OECD studies, about half of Irish private sector employment is sustained by this foreign demand – the second highest rate in the OECD. The report stresses that it is not just about volume; Ireland’s manufacturing industry

has successfully moved up the knowledge and value chains in recent decades. We have seen the emergence of clusters of world class manufacturing operations in sectors such as biopharmaceuticals, electronics, medical technology, and food production. Ireland’s level of employment in high-technology manufacturing, as a share of total employment, is now the highest in the EU. In addition, 29% of manufacturing jobs are in high technology sectors. This is four times the EU average. Furthermore, Ireland’s manufacturing industry features a large and growing number of companies which carry out advanced R&D activities both in their own right and in collaboration with State supported research institutions. These State support institutions include Enterprise Ireland, Industrial Development Authority and Science Foundation Ireland research and technology centres. Irish manufacturing business is now the sixth highest spending on R&D in the EU, on a per capita basis; the Irish medtech industry is the highest spender in Europe in its sector, while biopharma is fifth. Ireland’s ability to manage the move up the value chain whilst maintaining low unemployment and high wages is testament to how a flexible labour market with strong social cohesion and an excellent education system can provide the basis for international competitiveness.

Large footprint The Irish manufacturing sector has a very large footprint in relation to the size of the country. With just 1% of the EU’s population,

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Ireland accounts for 5% of its manufactured goods exports to the rest of the world. By comparison to our nearest neighbour, the UK is 13 times our size in terms of population but is only 2.7 times larger in times of manufactured goods exports. A number of factors have contributed to this outstanding success. These include our skilled, flexible workforce; a stable, transparent and competitive tax regime; membership of the EU Single Market with a regulatory regime conducive to doing business globally; a stable industrial relations regime; and a strong and reliable business culture. This comes with the guarantee that where problems arise, companies have unique high level stakeholder access. These have led to Ireland becoming a centre for international trade and one of the world’s most open economies. Ireland offers a platform and gateway for companies to access 450 million customers in the EU.

Strong indigenous sector Diversity is a key strength of Ireland’s manufacturing sector. While the inbound FDI element of the sector tends to command most public attention, the native component is of critical importance and accounts for more than 50% of employment in the sector. Of the €120 billion of Irish manufacturing exports in 2020, only 12% came from indigenous industry. But over the past decade, the sector has spent over €143 billion in payroll and purchases in the Irish economy. This is 54 cent in every euro spent by manufacturers, indigenous or inbound multinational, in the domestic economy. The importance of the indigenous manufacturing industry is possibly best identified by the thriving medtech sector, where homegrown Irish companies have played a leading role in the global battle against the Covid-19 pandemic. This pioneering group of innovative companies has developed new rapid diagnostics, ventilator, remote patient monitoring and a range of other ground-breaking solutions which are now in use by healthcare systems around the world. Manufacturing’s regional spread is also important, and the industry is a highly valued employer throughout the country, and particularly in rural counties. For example, manufacturing accounts for over 20% of private sector employment in 15 counties. In counties Cavan, Tipperary, Waterford, Monaghan, Offaly, and Sligo, manufacturing provides more than one in four private sector jobs. Irish PharmaChem | Industry Buyers Guide 2022


Manufacturing in Ireland The report contains a number of industry case studies, with Pfizer providing the case study for the biopharmaceutical sector.

Recommendations to Government The report makes a number of recommendations to Government, including: ● The need to improve the R&D Tax Credit Scheme; ● Taking a whole of Government approach to development and implementation of digital policies; ● Acceleration of the delivery of a National Broadband Plan; ● Ensuring national cyber security and data protection capacities are in place; ● Development of an end-to-end skills strategy for the manufacturing industry; ● Incentivisation of the co-location of R&D capacity with high end manufacturing; ● Adoption of a cost-effective approach to emissions reduction; ● The EU to continue to champion the openness of trade and investment with the retention of access to the UK market; ● The introduction of a State supported export credit insurance scheme; ● To ensure that regulatory frameworks keep pace with new technologies in a

The Ibec report identifies the top challenges for manufacturers in the coming months. way that facilitates and does not hinder innovation; ●

To critically assess all new regulations during development to avoid any negative impact on the business environment.

The report argues that the Irish manufacturing sector has never been more successful, nor has it ever faced greater challenges, including the impact of the

Covid-19 pandemic and Brexit, allied to the challenge faced by the decarbonisation imperative and the associated regulatory changes which will come into force over the coming decade. Government will have to support the sector to remain an engine of economic growth and employment creation in the years ahead. For more information, visit www.ibec.ie/ connect-and-learn/industries/ibec-networks/ manufacturing-in-ireland.

Suppliers of a wide range of raw materials/blending services to the pharmaceutical, biopharma and medical device industries

Carbon Group, Ringaskiddy, Co. Cork, Ireland, P43 R772 T: +353 21 4378 988 Contact: Carol Deegan T: +353 86 261 2485 E: carol.deegan@carbon.ie Irish PharmaChem | Industry Buyers Guide 2022

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PMTC At PMTC, our wide range of capabilities and deep domain knowledge and experience in pharmaceutical manufacturing allows the Centre to be relevant, agile and highly responsive to the unique and growing needs of our member companies. Situated within the Bernal Institute at the University of Limerick, this world class facility, with its extensive range of physical infrastructure and experienced post-doctoral researchers, supports companies across the biopharmaceutical manufacturing sector in optimising their manufacturing facilities within the framework of our three core research areas: • Pharmaceutical plant cleaning, including containment, changeover, and verification; • Process control and optimisation; • Data analytics and utilisation. Added to that, PMTC has a number of affiliated research performing organisations and research centres to assure we can place the industry need with the best academic talent and capabilities nationally. The importance of pharmaceutical manufacturing to the Irish economy cannot be understated. Ireland is the largest net exporter of medicines in the EU, with over US$85 billion worth of products being exported each year. This accounts for over 50% of the country’s total exports. The industry directly employs ca. 25,000 people, over half of which are third level graduates, with another 25,000 people employed in the provision of services to the sector. This critical sector is ever expanding and developing and PMTC’s objective is to support the continued growth and competitiveness of the sector in Ireland through excellent research and development outputs. With an emphasis on collaborative engagement with its industrial partners, PMTC is strategically positioned to address realworld challenges within the pharmaceutical manufacturing sector, ensuring that the needs of this important sector are supported into the future. Sitting at the interface of industry and academia, PMTC supports the pharmaceutical manufacturing industry and its supply chain of indigenous service providers to solve problems, while differentiating itself by focusing on industry-informed research, where research programmes are driven by real market needs defined by biopharma multinational operations in Ireland.

Focus on industry needs

Innovation through collaboration

As an industry led applied research organisation, PMTC relies on high engagement with our industry members, acting as an adjacent research and development organisation to help advance the pharmaceutical industry base in Ireland through relevant value added research outputs, which can be applied to Irish manufacturing sites, helping them to remain competitive and often to lead the way in key

Sarah Hayes, Director, Pharmaceutical Manufacturing Technology Centre, highlights the valuable work the PMTC carries out across its key research areas, including a landmark publication on data analytics within pharma manufacturing.

Irish PharmaChem | Industry Buyers Guide 222

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Steven O Manage


PMTC areas of strategic business importance. One such example is the area of data analytics application in the GMP environment. PMTC recognise that enabling pharma manufacturing sites to fully embrace and leverage advanced data analytics is now a critical need and shows the relevance of the research work undertaken at PMTC to best serve our industry partners and deliver tangible benefits in the near and longer term for Irish manufacturing sites. Data analytics is a core research area for PMTC, where we have delivered a foundational piece of research in ‘A Guide to Data Analytics for Pharmaceutical Manufacturing’. In effect, this guide is setting the scene to support pharma manufacturing sites advance towards digitalisation and the realisation of an Industry 5.0 manufacturing environment, understanding that data analytics is the cornerstone of the digital world. Published in December 2020, the guide has been distributed to PMTC industry members and is available to the public at https://pmtc.ie/ resource-centre/publications/data-analyticsgood-practice-guide. This pivotal piece of research work will serve as a basis for future collaborative research projects to build on this foundation set out in the guide and to arrive at both a common language and later a standardised framework best suited to pharmaceutical manufacturing, a regulated environment.

Supporting indigenous SMEs Having built up a strong membership base of biopharma multinationals since the establishment of the centre in 2013, now in the second phase of funding, PMTC has an ever increasing focus on broadening our SME membership base. Our goal is to provide Enterprise Ireland clients with unrivalled interaction with biopharma multinationals, enabling SMEs to grow through delivery of new technologies and solutions to MNCs in Ireland and beyond. In essence, the Centre provides a focal point for innovation and demonstration of new technologies and services for SME members, facilitating direct engagement and showcasing indigenous capabilities to MNCs. This is a key enabler for those indigenous companies, as well as providing rich ground for understanding the end user needs, which helps in product development, whilst allowing MNCs to influence how best these technologies can be applied in a pharmaceutical manufacturing context.

PMTC’s foundational piece of research, ‘A Guide to Data Analytics for Pharmaceutical Manufacturing’, will serve as a basis for future collaborative research projects.

delivery of real impact for member companies through the research outputs delivered by the centre. This strong emphasis on collaboration within the PMTC is not limited to the relationship between the centre and its members, but importantly, supports company-to-company engagement and collaboration across the Irish pharmaceutical manufacturing sector as a whole, thus enriching the ecosystem in Ireland.

In recognising this strong need for meaningful engagement, the PMTC hosts a number of communities of practice, whereby knowledge sharing is fostered, which in turn surfaces common goals, thus enabling collaborative research work between SMEs and MNCs. Additionally, to support strong industry engagement, PMTC provides opportunities for companies to network and stay abreast of new technology developments through events such as the PMTC Knowledge Day, as well as technical workshops and training events. Through our knowledge sharing across the PMTC community and acknowledging that talent and capacity development across the pharmaceutical sector in Ireland is a key success factor for the industry, PMTC supports member companies in the continued professional development of technical personnel in member companies and always seeks new ways to strengthen the talent pipeline in Ireland. Our recent focus on acquiring new digitally enabled pharmaceutical equipment and expanding use of Process Analytical Technology (PAT) are a prime example of that. We aim to provide a risk free environment for troubleshooting, development and optimisation of manufacturing and cleaning processes in both drug substance and drug product manufacturing, whilst using our capabilities to advance understanding of how advanced process controls can be applied. To get involved or learn more go to www.pmtc.ie or contact pmtc@ul.ie.

Collaborative engagement Collaborative engagement is core to PMTC. Our focus towards industry-led, highly engaged collaborative research strongly translates to the

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Digitally enabled fluidised bed system in PMTC exemplifies the capabilities of the centre in tackling process challenges for pharma manufacturing.

Irish PharmaChem | Industry Buyers Guide 2022


Inventing for life

At MSD we have and always will be... Inventing for Life. These three powerful words reflect our commitment to inventing new medicines and vaccines that save lives by preventing and fighting disease. MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ approximately 2,700 employees across six sites. A member of Guaranteed Irish, we are proud to be one of Ireland’s leading exporters and our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world. Learn more about the opportunities available in MSD Ireland at www.msd.ie

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All Rights Reserved.


SSPC SSPC, the Science Foundation Ireland Research Centre for Pharmaceuticals, co-directors: Professor Michael Zaworotko, Bernal Chair of Crystal Engineering, who is among the world’s top 20 research chemists, with Professor Gavin Walker, Bernal Chair of Pharmaceutical Powder Engineering, both based in the University of Limerick.

SSPC: advancing the pharmaceutical sector within Ireland SSPC, the Science Foundation Ireland (SFI) Research Centre for pharmaceuticals, is a hub of Irish research expertise, developing innovative technologies addressing key challenges facing the (bio)pharmaceutical industry. The aim of SSPC is to deliver industry-relevant technical solutions, which result in job growth and retention within this sector in Ireland and grow the skills base of qualified scientists and engineers. Founded in 2007, SSPC’s success is defined through its strong collaboration abilities and building R&D excellence in one of Ireland’s largest industries. Led by two co-directors, Prof. Michael Zaworotko and Prof. Gavin Walker, SSPC’s joint leadership synergises both science and engineering aspects of pharmaceutical development and manufacturing. SSPC is currently a Phase 2 SFI Research Centre with a vision to become the leading centre of excellence for shaping the future of the global pharmaceutical industry. This vision is being accomplished through an industryguided platform research programme that involves more than 70 investigators and

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SSPC is a hub of Irish research expertise, enjoying an unprecedented level of direct industry engagement, as it delivers industry-relevant technical solutions for the pharma and biopharma sector. covers five overlapping and interconnecting themes: molecules, materials, medicines, manufacturing and modelling. SSPC expanded its advanced research scope by moving to higher stages of drug development, while informing pre-clinical research and product lifestyle extension. Under these themes, SSPC’s research programme addresses a number of challenges: • Reducing time to market in drug development; • Advancing manufacturing through innovative technologies; • Improving efficacy of drug products; • Addressing new, more complex active ingredients.

Multi-disciplinary approach SSPC research is truly multi-disciplinary, leading to innovation in chemistry, process

engineering, data analytics, designer drug hybrid medicine (drug-antibody, peptide, oligonucleotide and glycoside conjugates), and mathematical modelling. Industry requires manufacturing systems that have full feedback control and which are self-correcting. In response, SSPC’s research advances process modelling, PAT, and statistical modelling for model-predictive control of pharmaceutical manufacturing. These new themes and new skillsets are having an immediate impact on the Centre, allowing SSPC to work at the interface of small and large molecule. While SSPC’s main expertise remains in the small molecules space, the new capability and capacity in the (bio)pharma space will have important consequences for the sector. Their bio capabilities include Gene & Cell Therapy, Protein Engineering, Drug Hybrid Conjugates, Protein Production and Modelling. SSPC works with 10 Research Performing Irish PharmaChem | Industry Buyers Guide 2022


SSPC Organisations (RPOs), including Trinity College Dublin (TCD), University College Dublin (UCD), Dublin City University (DCU), University College Cork (UCC), NUI Galway (NUIG), Maynooth University (MU), Royal College of Surgeons, Waterford IT, NIBRT (National Institute for Bioprocessing Research and Training) and its host, the University of Limerick (UL).

Collaborating with industry SSPC has a proven record of accomplishment in delivering excellent research that is critically informed by the needs of the pharmaceutical sector. SSPC brings RPOs and industry together to collectively advance the pharmaceutical sector within Ireland. SSPC has a strong emphasis on linking industry to research programmes and believes strong relationship management is a key to retaining industry members, and good communication processes and platforms help to maximise industry engagement across all aspects of the Centre. SSPC’s research platform is industry-guided, has industrial partners that have thus far supported university-industry projects and is working with 37 companies globally. SSPC has developed a flexible and responsive business model and has put immense work into ensuring high-level engagement to grow the business. SSPC researchers and operations teams have worked in partnership with industry to scope and develop 33 industryguided projects, both within and outside of the membership, collaborating with corporate R&D international sites. This level of direct industry engagement is unprecedented and highlights the perceived value of the Centre to its industrial partners. SSPC’s capabilities and expertise in large molecule research have also attracted the interest of a number of biopharmaceutical companies and resulted in a number of projects. Despite the impact of the Covid-19 pandemic, the Centre has managed to retain and grow its industry base to include new international collaborations with BMS (Germany), Kapaji (Czech Republic), Magritek (Germany), Canty (UK), Technobis (Netherlands) and Abbvie, Pfizer, Merck and MStar from the US.

Advancing talent SSPC attracts talent worldwide and produces PhD graduates and post-doctoral researchers with specific disciplinary expertise, coupled with a broad understanding of cognate disciplines across pharmaceutical science and manufacturing. A key impact of SSPC is the creation of a unique talent pipeline and the transition rate of SSPC researchers to industry currently stands at 65%. One of the key drivers of this is the SSPC PhD industry placement programme, which brings students into the industrial environment for Irish PharmaChem | Industry Buyers Guide 2022

SSPC’s industry-guided platform research programme covers five overlapping and interconnecting themes: molecules, materials, medicines, manufacturing and modelling. a three-month placement aligned with their research area. The availability of skills and talent is seen by the pharmaceutical industry as a prerequisite for future competitiveness, investment and employment

Societal impact The philosophy of SSPC is to solve real-life economic and societal issues by addressing key challenges in drug development. The overarching economic and societal impacts of SSPC are: (1) The retention, creation and transformation of direct jobs in the pharmaceutical industry in Ireland; (2) Enhanced education and training offerings to support a knowledge society;

supported in a number of ways in SSPC. Companies have the option to initiate fully funded industry specific research projects and retain project IP thanks to a flexible Irish IP protocol that facilitates industry-led project collaborations with Irish research performing organisations. Companies can also avail of SSPC co-funding (up to a max of 50%), providing organisations with the opportunity to develop collaborative research and the potential to licence back any IP arising. For more information on how SSPC can work with you, please contact Industry Engagement Manager, Aisling.Arthur@sspc.ie, and COO, Dr Sarah Hayes, Sarah.Hayes@sspc.ie.

(3) A ‘greener’ pharmaceutical industry; (4) Research toward greater availability and choice of medicines for patients at lower cost. The Centre’s focus is to make strategic collaboration a top priority and push the frontiers of knowledge. Its mission is to become the leading centre of excellence for shaping the future of the global pharmaceutical industry. SSPC researchers work in partnership with the international pharma and biopharma sector to solve key industrial challenges, enabling novel and efficient methods of manufacturing safer, cheaper and more effective medicines for the future.

Working with SSPC Currently, SSPC has an extensive portfolio of targeted research projects (mainly single industry directed). Industry projects can be

SSPC is globally recognised for API crystallisation, manufacturing research, modelling and biopharma expertise. SSPC’s culture of collaboration is helping the global pharmaceutical and biopharmaceutical industry to develop more environmentally sustainable methods for drug manufacturing; to increase the range of medicines available to the public; and to reduce drug-manufacturing costs.

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Medtech

Irish Medtech Awards presented The Medtech Rising conference saw the presentation of the Irish Medtech Awards. Director of Ibec Medtech & Engineering Sectors, Sinead Keogh, Head of Lifesciences Talent and Innovation at IDA Ireland Michael Lohan, and Enterprise Ireland’s Head of Life sciences Deirdre Glenn announcing that Limerick-based Serosep has been awarded Irish Medtech Company of the Year at the Association’s annual Medtech Rising conference, hosted jointly with Enterprise Ireland and IDA Ireland. Limerick-based Serosep has been awarded Irish Medtech Company of the Year at the Irish Medtech Association’s annual Medtech Rising conference, hosted jointly with Enterprise Ireland and IDA Ireland. “These awards offer a change for the medtech community to gather virtually to recognise and celebrate the strength and importance of the industry in improving life,” noted Sinead Keogh, Director, Irish Medtech Association. “We’re delighted to announce Serosep as this year’s Irish Medtech Company of the Year. Serosep is a selffunded, family run business, and manufactures clinical diagnostic products to over 35 different countries spread over five continents. The company is 25 years in business and employs 114 at its headquarters in Annacotty, Co Limerick.” Dermot Scanlon, CEO & Founder of Serosep Ltd, said that: “Serosep’s innovative diagnostic test solutions have disrupted the market and changed the way Gastroenteritis is tested in clinical laboratories. EntericBio is now the market leader in Ireland and the UK, with many more markets adopting the test on a routine basis. We are currently manufacturing in excess of one million tests in our state-of-the-art facility, matched with our ability to deliver excellent customer service, which sets us apart from the competition. Winning this award is testimony to the hard work, commitment and dedication of all our employees. We believe this award will motivate us all to continue forging ahead, achieving bigger and better things. We are deeply humbled, honoured and profoundly grateful to accept this award.” This year’s ‘Medtech Rising: Irish Medtech Awards’ included two new categories. Alcon Ireland won the Sustainable Medtech Company of the Year Award for its comprehensive sustainability programme, driven by its Site Leadership team, while West took home Irish PharmaChem | Industry Buyers Guide 2022

the Best Medtech Talent Strategy Award, for their ‘Our Talent, Our Future’ strategy.

pandemic, with its products being used with over three million hospitalised and critically ill patients since March 2020,” Deirdre Glenn revealed.

Recognising the role of start-ups and SMEs Enterprise Ireland’s Head of Lifesciences, Deirdre Glenn, explained how they are “proud to recognise the role that start-ups and SMEs play in Ireland’s dynamic medtech ecosystem”. She paid tribute to Luminate Medical, this year’s Emerging Medtech Company of the Year; the NUI Galway spin-out has developed a novel technology to prevent chemotherapy-induced hair loss. Vertigenius won the eHealth Innovation of the Year Award for its platform to enable enhanced clinical and patient engagement in the treatment of balance problems. “It is a healthcare platform aligned with healthcare needs as they are evolving, maximising the use of ICT to facilitate clinical service delivery through digital technologies,” Deirdre Glenn noted. Aerogen took home the Covid-19 Response Recognition Award, for its development of the world’s first ‘inhaled vaccine station’. “Aerogen has been at the forefront of medical response to the

Academic partnerships IDA Ireland’s MedTech Department Manager, Rachel Shelly, said: “Academic partnerships play a vital role in developing disruptive technologies in the medtech sector and the winner of the Academic Contribution to Medtech Award is Biomechanics Research Centre. The industry focused technology developed by BioMec integrates the latest in silico computational models to simulate the mechanical performance of implanted coronary stents. It’s terrific also to acknowledge the success of Jabil Healthcare Bray, which won the Medtech Partner/Supplier of the Year Award for its new product offering in molecular diagnostics, launching a Covid PCR testing device; and to acknowledge the company’s success achieving elite Shingo status.” Cook Medical won the Women in Leadership Company Initiative Award, which recognises companies that proactively take steps to increase the number of women in medtech and advancing to leadership positions.

Medtech Rising 2021: Irish Medtech Awards winners: Medtech Company of the Year Award: Emerging Medtech Company of the Year Award: Academic Contribution to Medtech Award:

Medtech Partner/Supplier of the Year Award: Women in Leadership Company initiative Award: Covid-19 Response Recognition Award: eHealth Innovation of the Year Award: Sustainable Medtech Company of the Year Award: Best Talent Strategy in Medtech Award:

Serosep Luminate Medical Biomechanics Research Centre (BioMec) – NUI Galway Jabil Healthcare Cook Medical Aerogen Vertigenius Alcon Ireland West

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We are in the business of breakthroughs – the kind that transform patients’ lives. Dedicated to our mission of discovering, developing and delivering innovations that help patients prevail over serious diseases and strengthen our communities. We’ll never give up on our search for more hope, for more people, around the world.

Visit bms.com/gb to see how we’re driving meaningful change for patients, their loved ones and for the communities and societies we all share. © 2021 Bristol-Myers Squibb Company. All rights reserved. March 2021 NO-GB-2100068

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Work Force The attraction and retention of talent are the top priorities identified by a recent Ibec survey of HR professionals for prioritisation in 2022. The availability of skills remains a challenge, with wage pressure due to the competition for skills, the second highest area of concern. In response to the demand for top talent, companies are revolutionising their talent acquisition strategies, piloting technologies, and recruitment/retention strategies.

Attracting talent The pandemic outbreak forced companies to become more creative in attracting and hiring new talent. Job seekers and talent recruiters had to adapt to a virtual format overnight, where online interviews, Zoom sessions, and virtual hiring events became the norm. Companies adopted new technologies to strengthen their recruitment processes in order to ensure they were gaining access to the widest possible talent pool and reaching candidates with unorthodox but suitable experience. Toolkits that inspire and engage both passive and active candidates when posting jobs are proving to be highly effective. These recognise that specific keywords and the number of requisite skills in a job description can be a factor in stopping some groups from applying. Social media platforms, virtual hiring events, referrals, and building both personal

Irish PharmaChem | Industry Buyers Guide 2022

Addressing the talent challenge Siobhán Dean, BioPharmaChem Ireland, explains why attraction and retention of talent are key priorities for the sector in 2022, and how an effective diversity, equity and inclusion policy can help your company succeed.

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Work Force

and employer brands are all playing a role in attracting talent. The creation and successful launch of the BPCI National Laboratory Apprenticeships in 2018 offers candidates a new pathway into the biopharmachem sector. This combines higher certificate and degree programmes with paid on-the-job learning and academic study. This programme has closed a gap for recent leaving certificate graduates and mature students who have an interest in pursuing a career in science but were unsure of how to initiate it because of financial or academic constraints.

Diversity, equity, and inclusion There is a strong business case to enhance and promote diversity, equity and inclusion strategies to attract the best talent and build high performing teams. Research shows that an organisation’s DE&I culture and policy is one of the key deciding factors for job seekers. This is especially the case for millennial and Generation Z employees, who will become a larger proportion of the workforce over the coming years. While diversity may have always been core to companies’ recruitment and people management policies and procedures, events in recent years have reinforced the importance of developing/promoting a strong equity and inclusion culture. Examples of initiatives in the sector can be seen in MSD and AstraZeneca. Each year, MSD dedicates the full month of September to celebrating Global Diversity & Inclusion Experience Month, fostering meaningful discussions and learning around diversity and inclusion through a series of events and company activities. AstraZeneca have established a global inclusion and diversity council that is populated by members from every country where the company have operations situated. Retention is a key issue across all sectors, with research showing that many employees are rethinking their careers and work life balance. One upshot to this new zeitgeist is the increased awareness placed on the value of staff, inspiring companies to develop workplace initiatives such as wellbeing, professional development and mentorship programmes. Investment in these types of programmes can play a vital role in staff retention when they are of relevance to employees and their needs. Communication and collaboration with employees during the process of designing such programmes can enhance their effectiveness. It is far more prudent financially and strategically to invest within the existing talent pool than to only look externally, especially now in this very competitive environment. Empowering employees to drive their own career development and creating pathways for their skills development is an excellent tool to develop one’s brand and to invest in exciting

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The pandemic forced companies to become more creative in attracting and hiring new talent, with online interviews and team calls becoming the norm. talent. It is not enough to invest in training and mentorship programmes; companies also need to develop a strong and adaptable learning culture, which in turn develops a more agile workforce.

Building partnerships “Life’s a marathon, not a sprint.” - Phillip C. McGraw. This maxim has been touted throughout the onset of the Covid-19 pandemic and is particularly important when thinking about STEM talent development strategies. Companies need to develop longterm strategies and have hand-over plans in place when champions move roles or exit completely. One way to enhance a company’s ability to innovate and meet the challenges of global competition is to build strong strategic partnerships with academia. While collaborating on research projects has long been a way to build such partnerships, the biopharmachem sector has more recently been looking to third level institutions to maximise their ability to produce talented graduates with both the scientific and transferable skills required for future challenges and opportunities. Standalone modules and short programmes designed for the sector, along with initiatives such as Skillnet, Springboard and Apprenticeship programmes, can help to meet

the need for skills in innovation and quality. The STEM Teacher Training Intern programme is an innovative programme started by DCU in 2016. The programme enables pre-service STEM teachers to gain first-hand experience of what it is like to work in a STEM industry, the diversity of roles that are available to people who pursue these fields and the variety of paths that one can take towards working in the industry. This programme helps to empower teachers with the knowledge they need to inspire their students to engage in STEM and consider a career in the sector. The programme hosted 45 pre-service and in-service teachers and 25 host organisations in 2021. Among those host organisations were four from the biopharmachem industry: Abbvie, Alexion, APC & VLE Therapeutics and MSD. The programme will be extended to NUIG, UCC and UL in 2022, so there will be abundance of eager and enthusiastic candidates to take up internship in the biopharmachem space. Climate change, Brexit and pandemics are some of the things changing the way we live and work. There will be many disruptions, but there will also be some fantastic opportunities to innovate, create, inspire, and transform.

Irish PharmaChem | Industry Buyers Guide 2022


ANNA LIVING WITH HPP

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• Quality Assurance Release & Certification • External CMO Management • Global Supply Chain, Finance, HR and IT Functions

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Coworking Laboratory Space Coworking laboratory spaces are one of the fastest-growing sectors in the real estate economy. Shared lab coworking spaces grew in the U.S from 12 million square feet ​in 2018 ​to more than 51 million square feet​in 2020​​, and the trend of labs + coworking is now catching on ​in Ireland - specifically in the wet lab / life science sector. The ​‘digital’ ​coworking concept has gone through ​a revolution over the last few years in Ireland, with multiple international and domestic operators now in the market. ​​ Operators like ​ WeWork have grown rapidly in Dublin, whilst the likes of ​Talent Garden in DCU, Dogpatch and Huckletree in Dublin City Centre, Republic of Work in Cork, Portershed in Galway​,​and Catalyst in Belfast,​ amongst others,​have all established or expanded operations over the last few years​. What you won’t see in any of these d ​ igital​ coworking facilities however, is specialised wet lab space for life science innovators.​I​n order to accommodate the burgeoning life science​ start-up sector in Ireland,​the coworking model needs to adapt and cater for early stage businesses that need specialised and flexible space, suitable for innovation activities in the fields of bioprocessing, therapeutics, drug discovery, Cell & Gene / RNA Therapies, genome editing and precision medicine, amongst other segments.

Fostering innovation and agility in life sciences

A first for Ireland: lab coworking in Cherrywood

The Campus Cherrywood is one of the first​ locations in Ireland to encourage and spark this trend​, with the arrival of ‘We Are Pioneer Group’ (‘WAPG’ - formerly BioCity) and the creation of a unique innovation facility for life science entrepreneurs. Th​e​​Irish ​spirit of innovation and agility ​in The Campus Cherrywood​is a new collaboration between specialist life science ​is what Spear Street Capital (SSC) is innovation space developers and life science innovators, offering looking to foster at The Campus Cherrywood. coworking laboratory spaces for the first time ever in Ireland. SSC is an owner and operator of distinctive properties located in the United States, Canada and Europe, and is investing in next generation innovation infrastructure to provide a world leading life science facility for Irish start-ups and scale-ups. This is in keeping with their innovation-led real estate cluster strategies in Boston (life science), Toronto (AI) and San Francisco (digital manufacturing).

Pay-as-you-go wet labs In Cherrywood​ ,​SSC is investing in much needed innovation infrastructure for life science start-ups (in the form of ‘pay-as-yougo’ wet labs), and bringing a world-leading life science incubation and acceleration platform in the form of ​WAPG as an operating partner. This collaboration, between specialist innovation space investors/developers and world class life science innovation platform operators, has been a strong emerging theme

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The 30,000 square feet ​WAPG ​facility ​in The Campus Cherrywood will anchor ​a​new ​life science ​cluster, linking client businesses there to hundreds of other life science companies, mentors, investors and partners.​ Irish PharmaChem | Industry Buyers Guide 2022


Coworking Laboratory Space

Having access to ‘pay-as-you-go’ lab facilities and business support services from a world class operator is a huge advantage to life science start-ups.

scaling Irish life science companies.​ T​he Insight SFI Research Centre for Data Analytics, a national network of over 400 Irish academic data analytics experts, with a keen focus on life science and health data, will also establish a footprint to showcase its research and collaboration with industry in the area of ‘Augmented Human’ at the intersection between data analytics and life science​.​

An incubator for high potential start-ups The WAPG facility itself will act as an incubator building for high potential Irish life science businesses. WAPG will also run regular accelerator and venture building programmes for Irish and international life sciences startups, helping to bring innovations ‘from bench to bedside’, and connecting start-ups to globally over the last few years, and this is its Alongside the starter and medium scale investors, mentors, partners and to life science first manifestation in Ireland. high specification wet labs will be a coworking multinationals.​ WAPG and The Campus Cherrywood lab where individual benches can be rented Having access to ‘pay-as-you-go’ lab facilities generally will build on the presence of leading by entrepreneurs and researchers on a month- and business support services from a world life science companies already on-site, such to-month basis. The​se​new high-end wet lab​ class operator is a huge advantage to life as APC, Genuity Science and Zoetis. WAPG is capabilities​of varying scales ​will be available to science start-ups. This model currently does a world-leading innovation platform for life entrepreneurs, researchers, start-ups, scale-ups not exist in Ireland, which is currently an sciences businesses and has 12 locations across and corporate teams on a flexible lease basis, impediment to the growth of indigenous life the UK, where it caters for 650 businesses.​ obviating the need for ​heavy ​investment in science businesses in Ireland. The 30,000 square feet ​WAPG ​facility ​in The expensive lab space for early stage companies A recent study by Nottingham Trent Campus Cherrywood will anchor ​a​new l​ife in particular. University Business School found that UK science ​cluster, linking client businesses there biotechnology incubators play an important to hundreds of other life science companies, Dedicated NIBRT lab role in supporting new life science companies. mentors, investors and partners throughout There are also plans to establish a dedicated Furthermore, according to the ‘UK life science the WAPG network.​ ​The ​WAPG ​facility will lab for the National Institute for Bioprocessing start-up’ survey, over 75% of the total UK house four medium scale laboratories, 11 Research & Training (NIBRT), a collaboration national activity of new life science companies starter laboratories and nine associated office/ between UCD, Trinity College and DCU, is located in a city with a biotechnology write-up space units, catering for approximately amongst others. NIBRT is a recognised global incubator. 15-20 life science companies of varying sizes centre of excellence and is in advanced The Campus Cherrywood and this first piece and maturity and accommodating over 100 discussions to establish a lab operation at The of life science innovation infrastructure points new life science R&D jobs.​ Campus Cherrywood to accommodate and to an opportunity for indigenous start-ups Life sciences companies usually start with facilitate their growing cohort of principal to flourish alongside research and academic a small amount of lab space as they achieve investigators and corporate R&D projects. staff, as well as in partnership with scaling and proof of concept before they acquire their own The facility also affords NIBRT the opportunity established life science companies, in a true expensive equipment, customised lab space to engage with and assist early stage and cluster environment. and investors that can support their work.​​ A coworking model applied to a laboratory setting provides additional workspace, amenities, collaboration and idea-sharing that a growing company needs​,​ but they may not be able to afford their own dedicated lab and office just yet.​​As a result, lab coworking projects have become wildly popular and specially designed with larger floors and higher ceilings to handle potential lab tenants and their utility requirements. ​The WAPG subscription-based lab ​and​ coworking model ​ also provides access to all the equipment​and services​​an early stage or scaling life science company might require: washing and autoclaving, incubat​ion/ acceleration of ideas​, ​mentoring, early stage The Campus Cherrywood offers indigenous start-ups the chance to flourish alongside research and investment, lab operational services (such as academic staff, as well as in partnership with scaling and established life science companies, in a true lab coat laundering), and biohazardous waste ​ cluster environment. management​, etc.​ Irish PharmaChem | Industry Buyers Guide 2022

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Steven O Manage


Pfizer

Pfizer has invested $40 million in its Grange Castle plant to produce the nRNA drug substance, the active ingredient in its Covid-19 vaccine.

Pfizer to produce Covid vaccine in Dublin

Pfizer recently announced an investment of $40 million to support the production of the mRNA drug substance for its Covid-19 vaccine at its Grange Castle facility in Dublin, only the second plant outside its Massachusetts home to do so. “It is hugely significant that the production of the mRNA drug substance for the Covid-19 vaccine will be done at our Grange Castle facility,” explains Paul Duffy VP, Small Molecule Operations. “It is really exciting to think about the role that mRNA can play in future medicines.” The pandemic has proved to be a learning experience for the company. “It has been very interesting for us overall,” admits Duffy. “However, the biggest learning has been the vaccine story. The ability to move from vaccine discovery to manufacturing and on to supplying doses at such pace has been extraordinary. Our recognition that good science demands rigour, our commitment to patient safety, and our close partnership with regulators that are equally committed to scientific integrity was hugely pivotal in

achieving success with our vaccine. What we learned was that there is a huge amount to be gained from our decision to undertake several processes in parallel that traditionally have occurred sequentially.” Pharmaceutical companies traditionally wait for approval before investing in manufacturing, Duffy explains. “In the case of the Covid vaccine, Pfizer invested $2 billion in manufacturing before it was proven to be effective and approved. That was a very big bet, but we would not have been able to supply the vaccines so quickly without making it.” Moving away from the sequential model also saw the company bringing suppliers and other partners into the process before they would normally have been needed: “We are now seeing new ways of doing things and how to get to the end of the process quicker.”

Longterm investment in Ireland Total capital investment by Pfizer in Ireland now totals over $8 billion, following the November

2020 announcement of a €300 million investment programme in the continuing development of the manufacturing sites in Grange Castle, Newbridge and Ringaskiddy. The investment will provide additional manufacturing and laboratory capacity creating approximately 300 roles, with additional anticipated construction roles in Ringaskiddy, Cork. Part of the investment includes the construction of a development facility on the existing Ringaskiddy site to manufacture pharmaceutical compounds for Pfizer’s clinical trials globally. “This is a very important development as it expands Pfizer’s role in Ireland from the manufacture of already approved medicines into supporting the earlier phases of new medicine development,” reveals Duffy.

Significant manufacturing base Ireland is now a significant manufacturing base for Pfizer globally, with many of the company’s leading and newest medicines produced in this country. Manufacturing activity spans active pharmaceutical ingredients (APIs), solid dose pharmaceuticals, sterile injectables, vaccines and biopharmaceuticals. The Irish sites manufacture medicines and vaccines in the areas of arthritis, inflammation, cancer, anti-infectives, haemophilia, pain and stroke among others. In addition, a significant element of Pfizer’s Worldwide Research & Development (WR&D) is based in Ireland. The Global Biotherapeutics Technology group was established in 2006 at Grange Castle and is part of a world-leading protein drug discovery unit within Pfizer Worldwide R&D.

Quality testing of Pfizer’s Covid-19 vaccine at its Grange Castle site.

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Duffy is very positive about the future of Pfizer both globally and in Ireland: “Our pipeline is vast, and I am very optimistic about our ability to move new medicines through the pipeline safely, reliably, and successfully… We continue to be supported by Pfizer globally as evidenced by the latest €300 million investment. It is important for us to deliver on that, and I am confident that we will. We have done it for the past 50 years and we will continue to do so.” Irish PharmaChem | Industry Buyers Guide 2022


© 2021 PwC. All rights reserved.

Your Partner in Pharma We help manufacturers achieve step change business impact from emerging technologies. Our Smart Factory team helps you shape your digital programme, using it as an enabler for business strategy. We provide a range of services to support you at every point in your journey. We have the multi disciplinary team and expertise to deliver the maximum impact to you when considering R&D activity. At PwC, We advise on the R&D incentives available in Ireland and develop the systems and processes needed to deliver successful and robust claims for each incentive.

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30/11/2021 16:43


Certification

What ISO 50001:2018 means for your business ISO 50001 Energy Management System certification provides a framework for establishing energy management best practice, to help organisations to improve their energy efficiency plus make a return on investment by implementing ISO 50001. The standard enables organisations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use, and consumption. ISO 50001:2018 is an international standard. As it follows the same High-Level Structure (HLS) as other widely applied ISO standards, such as ISO 9001 and ISO 14001, it will be easier to integrate with other management systems.

Benefits of ISO 50001 By achieving certification to this international, best-practice energy

management standard, your organisation will accrue some of the numerous benefits of ISO 50001, including:  Energy reduction of up to 10% within first 12 months;  Reduced greenhouse gas (GHG) emissions and carbon footprint;  Globally recognised international standard;  Assistance in compliance with current and future voluntary and/or mandatory energy efficiency targets;  Improved corporate image and credibility among customers, clients and stakeholders;  Informed decision-making processes from system design through to operation and maintenance;  Increased energy awareness among staff members at all levels;

Improved operational efficiencies and maintenance practices.

The energy management standard lasts for three years and is subject to mandatory audits every year to ensure compliance. At the end of the three years, you will be required to complete a reassessment audit in order to remain certified for the next threeyear cycle.

ISO 50001 – Energy Management Training  

Transition training; Implementation training;

Lead auditor training;

Carbon literacy training; Building Energy Champion training; Transport Energy Champion training.

 

Contact Certification Europe for a free, no-obligation competitive quotation from their dedicated business development team. For more information, contact: Certification Europe, Block 20A, Beckett Way, Parkwest Business Park, Dublin 12 D12 P8R2. Tel: (01) 6429300. Email: sales@certificationeurope.com

ISO CERTIFICATION ISO 14001 / ISO 45001 / ISO 50001 ENVIRONMENT

HEALTH & SAFETY

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CONFIDENCE | ASSURANCE | CERTAINTY

+353 (0) 1 642 9300 certificationeurope.com info@certificationeurope.com 62

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Irish PharmaChem | Industry Buyers Guide 2022 15/10/2021 12:45:17


Learning & Development

The evolution of Skillnet BioPharmaChem (BPC) Skillnet was established in 2006 with the aim of fostering a climate of whole-company development in the provision of industry specific technical and non-technical training within the pharmaceutical, biopharma, chemical, and medical device sectors. BPC Skillnet is a Skillnet Business Network that supports the growth and development of global and indigenous organisations across Ireland. Promoted by BioPharmaChem Ireland and cofunded through Skillnet Ireland and businesses, BPC Skillnet, through continuous interaction and engagement across industry, has developed into a network with unique capabilities to support talent development, while also facilitating invaluable networking and benchmarking opportunities for the sector.

An unprecedented time 2020-2021 has been an unprecedented time which brought significant change and challenges to organisations, with BPC Skillnet being no exception. However, with these challenges, opportunities have also presented themselves and we are very proud of our significant achievements over the past two years. These achievements have been driven by the needs of the sector and guided by the Skillnet Ireland strategic pillars of Workforce Design, People Development Irish PharmaChem | Industry Buyers Guide 2022

Susan Costello, Network Manager, BioPharmaChem Skillnet, explains how the BPC Skillnet has evolved into a network with unique capabilities to support learning and development, even in the midst of the pandemic. and Strategic Innovation. BPC Skillnet has been instrumental in facilitating business transformation in industry by offering talent development solutions to companies, while also allocating significant resources to future skills requirements. Within weeks of the onset of the Covid-19 pandemic, BPC Skillnet demonstrated innovation and agility in our ability to transfer all programmes to online/virtual platforms. This ensured that the businesses we support could continue to develop their talent through the network, while also affording employees, many of whom were working remotely for the first time, a platform to engage with and learn from their peers.

Rolling out virtual training programmes As a network, we have assisted members in their efforts to seamlessly continue to invest in lifelong

learning, with hundreds of talent development programmes being rolled out virtually for member companies throughout the country over the past 18 months. Our programmes are: • Optimised for maximum transfer of learning; • Flexible, blended and accessible for industry; • Highly integrated with current and future workforce trends, enhancing the value to businesses; • Agile, responsive to the ever-changing landscape of the workplace in Ireland as we continue to collectively navigate the unprecedented territory that has been Covid 19. Over the past two years, the network has facilitated the delivery of over 650 programmes to almost 4,000 people across the country. Employees in industry embraced the opportunity to participate in programmes via online/virtual platforms, which had the benefit of removing many of the logistical

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Learning & Development barriers in attending face-to-face sessions. Academia, training providers, network members, participants and the network all collaborated to ensure the enforced transformation of learning and development was achieved seamlessly for all involved. The vast majority of programmes were transferred to remote offerings, across a range of platforms, with access to recordings made available where possible. This resulted in a huge increase in demand for programmes in the areas of Project Management, Personal Effectiveness, Managing Remote Teams, and Root Cause Analysis, along with numerous technical programmes and an increased demand for improved digital and virtual skills.

Skills Connect During this time, the network has also supported a number of member companies navigating the challenging experience of site reduction and closure. Through the Skills Connect initiative, BioPharmaChem Skillnet has been working in partnership with these companies in identifying and developing programmes for their employees, with a view to enabling members of their workforces to transfer to roles across the broader biopharma sector. Certified programmes, such as Bioanalytical Techniques, Supply Chain Management, Yellow Belt Training, Biopharmaceutical Technologies, GMP and Biopharmaceuticals and Management Development, have all contributed to ensuring these employees are equipped with knowledge and expertise that is current and of relevance to the sector.

Virtual Reality training programmes The network is also proud to extend its value to the sector through securing funding under the Skillnet Ireland Future Dynamics Co Creation

Transferring training programmes to online/virtual platforms ensured that businesses could continue to develop their talent through the network, while also affording employees, many of whom were working remotely for the first time, a platform to engage with and learn from their peers. Programme. This has enabled the development of our Biomanufacturing course on Aseptic Techniques in Virtual Reality. This programme is the first true virtual reality (VR) training programme built for novice biomanufacturing technicians and operatives in Ireland. The programme was developed by a team from Technological University Dublin and directed by a subgroup of network personnel from companies, including Abbvie, Sanofi, Janssen and Alexion. Based on the success of this programme, BPC Skillnet has recently secured funding to develop a second virtual reality programme for industry. Our aim is to develop a programme on dry powder operations in API manufacturing utilising

BioPharmaChem Skillnet has rolled out hundreds of training programmes virtually for businesses throughout the country over the past 18 months.

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immersive technology. A VR programme will allow novice operators to visualise the operating environment and practice tasks to be completed within the virtual space. This programme is currently on track for launch in March 2022.

Research identifying resource requirements 2021 also saw the network secure funding through the Skillnet Ireland Industry Insights Programme. This will provide the network with an opportunity to publish a cohesive piece of research specifically for the biopharmachem sector in Ireland. The industry-based research will use both qualitative and quantitative methods to enhance the richness of data. This will support the sector’s diversity and inclusion strategy by identifying resource requirements for the growing biopharma industry. It is envisaged that the project, which is currently in the early stages, will be completed by the end of June 2022. Networking and benchmarking are also a key focus of the network, providing industry with the opportunity to discuss current hot topics and future trends. Human error is always a point of interest for the sector and the network was delighted to be in a position to facilitate a Human Error Forum with the HPRA and BPCI in November 2021. One of the outputs from this event is an industry benchmarking and maturity concept that the network will facilitate. A follow-up event on this topic is planned for 2022. As the BPC Skillnet continues to expand and evolve and with the ongoing transformation of workplace learning, the network will continue to work in partnership with industry to design and deliver enterprise led, talent development solutions for the sector. Irish PharmaChem | Industry Buyers Guide 2022


Specialist Integrated CDMO

Hovione: endto-end solutions from one site Hovione has 60 years of experience as a Specialist Integrated CDMO (Contract Development and Manufacturing Organisation), with a range that includes drug substances, drug product intermediates and drug products. With four FDA inspected sites in the US, Macau, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers with services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical

customers, the company offers niche off-patent API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services. As a leader in spray drying, Hovione has the largest capacity, the best scale-up science and the most experienced team to take your project from development to market. With a view to helping customers solve complex problems, Hovione has invested in building know-how and expertise in particle design

and formulation development for highly sophisticated inhalation APIs. They apply QbD principles in every carrier-based or composite particles formulation development endeavour, ensuring early-on scalable processes to their partners. Hovione offers end-to-end solutions at a one-site-stop, from drug substance to drug product intermediate to drug product, which means API synthesis, particle engineering, formulation and powder filling can all be developed, characterised and GMP manufactured on the same site. These integrated services can

minimise risk, save cost and time on development and manufacturing processes. For more information, please see www.hovione.com.

hovione.ie

Irish PharmaChem | Industry Buyers Guide 2022

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Laboratory&Testing Investment Development

Eurofins BPT: unparalleled support for ATMPs Eurofins BPT’s local presence ensures personal service, backed by the unique global breadth of harmonised capabilities that support all functional areas of bio/pharmaceutical drug development and manufacturing.

Eurofins BioPharma Product Testing Ireland offers unique and unparalleled breadth of service and experience for Advanced Therapeutic Medicinal Products, including Cell & Gene Therapies. 2021 has been an exciting year for Eurofins BioPharma Product Testing (BPT) Laboratories in Dungarvan, County Waterford, as they continued to support an ever-broadening range of high efficacy cutting edge therapeutics through addition of the latest analytical technologies, in partnership with some of the world’s most innovative companies. This service expansion follows on from the 2018 increase of capacity from 2,700m2 to 8,800m2, when an additional 3,000m2 was designated specifically to Bioanalytics & Molecular Cell Biology. In 2022/23, they will again increase capacity for ATMP and will establish CAT 5 containment. The team at Eurofins BPT Dungarvan have an increasing number of gene therapy programmes, in which they have established analytical strategies, across all levels of development and in line with regulatory requirements. Their bespoke, purposebuilt GMP BSL2 laboratories have supported this advancement in Gene Therapies: • Viral Vector (AAV, Adenovirus, Lentivirus); • Nanoparticle Vector; • Plasmid Based; • iRNA/mRNA; • Viral Vaccines/ Oncolytic Viral Therapies; • Oncolytic Peptide Vaccines. Testing support is available at all phases of product development: • Raw materials; • Cell banks; • Viral banks; • Bulk vector harvest; • Up/Downstream manufacturing.

Rising to the challenge Eurofins BPT Laboratories in Dungarvan, support an ever-broadening range of high efficacy cutting edge therapeutics through addition of the latest analytical technologies, in partnership with some of the world’s most innovative companies.

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2021 provided many challenges to the industry but Eurofins BPT’s Dungarvan laboratory adapted to minimise service disruption and ensure continuity Irish PharmaChem | Industry Buyers Guide 2022


Laboratory Testing of delivery to their clientele, meeting the most challenging of deadlines. As client internal priorities shifted to support the acceleration of Covid-19 therapies to market, their laboratories flexed and rose to meet the urgent demands for raw material, intermediates and finished product analyses. With the challenges of new and prioritised product types where time means lives and not just money, comes a renewed focus on delivering the most appropriate technological solutions. As an example, their microbiology labs now deliver rapid mycoplasma testing. Demand for biopharmaceuticals and cell/ gene therapies support will continue to grow in 2022 and Eurofins BPT Dungarvan is positioning itself to be the trusted full solution provider to their broader national and international clientele. Its central position within the harmonised global network of 38 labs in 19 countries delivers efficiencies for their multi-national clientele and access to unique technological solutions in all major geographies. A method developed at their sites in Asia, mainland EU or the US is readily deliverable in Ireland under their global harmonised quality and informatics system (and vice-versa). Amongst their key strengths is an unmatched level of operational resiliency, derived from a global reach and the ability to transfer projects internally to mitigate unforeseen risks. In light of the recent pandemic challenges, their clients have greatly valued their interoperability with group labs in all geographies to keep their products on the market.

Global is local Eurofins BPT Dungarvan is very well placed to assist the diverse pharma and biopharma operations in Ireland and beyond, irrespective of the stage of product development. Their access to world leading centres of excellence within the Eurofins BPT network for specialist/ niche services such as assay development, structural characterisation, process and product impurity profiling and GMP nuclear magnetic resonance, has resulted in increased efficiency, product safety and ultimately profitability for their partners. Eurofins BPT’s local presence ensures personal service, backed by the unique global breadth of harmonised capabilities that support all functional areas of bio/ pharmaceutical drug development and manufacturing. With a global network of 38 facilities located in 19 countries, their network of GMP laboratories and vast experience allow them to support projects of any size, from conception to market. Furthermore, they have teams of scientists placed at more than 85 client facilities worldwide through their awardwinning Professional Scientific Services (PSS) insourcing programme.

Experience class leading expertise Eurofins BPT offers complete CMC Testing Services for the bio/ pharmaceutical industry, Irish PharmaChem | Industry Buyers Guide 2022

The microbiology labs at Eurofins BPT Dungarvan now deliver rapid mycoplasma testing. including all starting material, process intermediates, drug substance, drug product and manufacturing support, as well as broad technical expertise in biochemistry, molecular & cell biology, virology, chemistry and microbiology.

International presence means global regulatory compliance Operating under strict, harmonised quality procedures, Eurofins BPT’s laboratories offer a broad range of methodologies under GMP authorisation, ISO 17025 accreditation and ISO 9000 certification, and all analyses are performed according to European and British Pharmacopoeia (EP), United States Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP), as well as specific customer methods.

Collaboration drives cost-effectiveness “At Eurofins BPT, our fundamental philosophy is to help clients efficiently allocate research and manufacturing expenditures by strategically engaging them to meet unique outsourcing needs,” ” explains Dr Colin Crowley, Director - Business Development, UK & Ireland.” As their project progresses, to further enhance open dialogue and assist their decision making, we provide timely and secure access to comprehensive laboratory information through our innovative, 24-hour online data access tool, LabAccess.com.”

Comprehensive services Eurofins BPT offers the flexibility to manage testing programmes more efficiently through three unique service models, including their Professional Scientific Services (PSS), Full Time

Equivalent (FTE) or traditional fee-for-service. Their clients can choose the best, most costeffective service solution for their project goals and transition as their need grows. Their breadth of services includes: • Method establishment, including method development, feasibility, optimisation, cGMP qualification and validation, as well as verification of compendial methods; • Comprehensive stability and release programmes for clinical and marketed products; • Complete biochemical and chemical characterisation and microbial identification; • Raw material and excipient testing (USP/ NF, EP, JP); • Packaging testing; • Production and non-production cell banking, including full characterisation; • Lot release/unprocessed bulk testing; • Process/facilities validation, including viral clearance, residual impurities testing, extractables & leachables, water testing, environmental monitoring, disinfectant efficacy and on-site sample collection; • Consulting/protocol writing; • GMP manufacturing. Eurofins BPT Dungarvan has the physical and technical capacity to be the partner of choice for their clients’ most critical projects. They look forward to delivering best in class service. “When the world awaits your product, choose the laboratory that provides complete capabilities and rigorous quality systems you can trust,” concludes Dr Crowley.

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SkyCell Hybrid Containers: Safeguarding Sensitive Medicines With the rise of biologics, as well as stricter compliance and environmental regulations, pharma companies require a new solution to meet these challenges. At SkyCell, we developed a hybrid container solution that offers pharma companies greater flexibility in the handling of temperature-controlled products.

The best of both worlds For over 20 years, the cold-chain market has been divided into two worlds: active and passive. At SkyCell, our hybrid containers seamlessly combine and upgrade technologies of active and passive solutions, such as a longer runtime and hard exterior shell. Our hybrid container’s average independent runtime of 8.4 days (202hrs+) is made possible through our patented phase changing material and Swiss precision engineered design, offering added security to any delivery destination worldwide. A fully audited solution Safety is essential when it comes to life-saving medicines. With temperature excursions contributing to over $34 billion in losses in the biopharma logistics market, audited, tested and approved solutions are vital. Through our datadriven approach and annual quality audit by a global top auditor certifying a proven performance of less than 0.1%, we go above and beyond international standards with our hybrid containers.

Dynamic hardware and green initiatives Through strategically developed hardware our hybrid solutions offer additional protection from shock, vibration and humidity. Our cold chain solutions cover internal temperature ranges from -80°C to -60°C, -30° to -15°C, +2°C to 8°C and +15°C to 25°C. They are also shipped readyto-use and can function within any ambient environment to get life-saving medicines to patients. Hybrid not only safeguards medicines, but also the environment too. Through implementing the Circular Economy into our hybrid solution, we have stopped contributing to landfill waste. The efficient design also leads to a reduction of CO2 emissions by as much as half, as the containers are built from a recyclable multi-layer material for a safe and sustainable delivery worldwide.

We designed the Hybrid Container to set a new standard. It’s quite exciting to see, after 8+ years of operating Hybrid Containers, that they have an audited performance of less than 0.1% temperature excursions. With hybrid covering more than 100 countries, we continue to meet our goal of no loss in the pharma supply chain.

Richard Ettl, SkyCell CEO


Safe. Secure. Sustainable. The future is hybrid. Globally available in over 25 service centers across North America, Latin America, Europe and APAC regions Up to 50% CO2 reduction and elimination of landfill Audited performance of less than 0.1% temperature excursions with an average runtime of 8.4 days (202hrs+)


IT Services

Westbourne’s world: where your critical technologies always work Westbourne IT Global Solutions Ltd work with their client’s IT department as an outsourced extension of their team, delivering short, medium- and long-term projects in their laboratories such as: • Innovation projects – road maps for moving to paperless labs; • Computer System Validation (CSV) and documentation projects; • Lab Application Upgrades – instrumentation / software; • Business Process Improvements - reducing compliance risk, process automation; • LIMS – LabWare / LabVantage upgrades / installation, integration projects; • Pre-audits / site surveys; • Data analytics – forecasting and planning. Their lab service puts lab users in a data-driven IT environment and at the centre of their business. They offer In Lab, Near-Lab and Remote-Lab support and provide exceptional right first-time fix rates from their team of IT-enabled scientists and lab savvy IT engineers. Westbourne IT’s teams provide support for lab applications such as LIMS, LES, Empower, Discoverant and Citrix. Additionally, their people ensure that your IT network is working end-to-end, so laptops, software and infrastructure work together with customer lab systems. The impact of the everincreasing digitalisation of our world at the business

and the social level is increasing expectations on IT support. Always available, “always up” becomes a challenge for labs and IT.

Why Westbourne?

• GxP Compliance o Fully compliant engineers; o Rigorous up-skill training programme: • Driven by forward thinking and highly qualified training department; • GAMP5 and CSV certified. • Confidence in people supporting your labs o Proven track record of delivering lab projects; o Effective communication (multi-lingual, professional); o Highly qualified and certified staff; o Bench of engineers to ensure uninterrupted service levels; o ITIL and SDI trained. • Confidence in your IT infrastructure and applications o ITIL driven ticket resolution; o High ‘right first time’ fix levels; o Metric driven continuous improvement initiatives. o Indicative Dashboard below gives a flavour of their approach.

Cost effective and flexible o Shared or dedicated service; o Pay only for what you need; o Stand alone or integrate into your existing solution; o Grow as you grow; o Flat reporting structure so greater control over quality of service; o Onsite / off-site.

Who are Westbourne IT? Founded by Chief Executive Officer, John O’Sullivan in 1994, Westbourne IT Global Services Limited delivers multi-lingual technical service desk solutions and lab IT to highly regulated companies in the BioPharmaceutical, med-tech and food sectors, on a global scale. They are a flexible, niche provider of top-end, high-quality remote and on-site IT services on a 24 x 7 x 365 basis from their delivery centres in Cork and Auckland, New Zealand. The focus is always on putting customer service and ticket ownership at the centre of their service to deliver an exceptional customer experience in over 10 languages, with follow the sun availability.

Client range Westbourne IT’s clients range from start-ups to top 10 pharmaceuticals, biotech and food & beverage companies.

For more information, contact: Westbourne IT Global Solutions Ltd The Atrium, Blackpool Business Park, Cork Tel: (021) 4314310 www.westbourneit.com Contact details: James Symington Email: James.symington@westbourneit.com

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Irish PharmaChem | Industry Buyers Guide 2022


Elite Technical Support 150 engineers, operating on and off site, nativespeakers in 10+ languages, ITIL accredited

Ensure critical enterprise technologies are always available. Our highly skilled, multilingual teams of engineers in Ireland, US, UK and New Zealand deliver a collaborative global service model that drives productivity with excellent customer satisfaction ratings.

Enterprise Service Desk

Lab IT Services

Project Services

24/7/365 remote and onsite support for all your business needs. With offices based in several countries, we can provide technical assistance in all of the top 10 European and Asian languages.

Westbourne provides onsite technical support for all your lab applications ranging from LIMS to CDS. We also offer a remote service for those wanted to save on desk-space.

We support companies for short term projects, from lab based CDS to Windows 10 IT upgrades. We can provide onsite staff from 1-9 months to support you through your project.

Westbourne IT - Experts in Global Enterprise Service Desk including Manufacturing and Labs IRELAND | USA | New Zealand, www.westbourneit.com, James.Symington@westbourneit.com +353 (0)21 431-4310


IT Services

Optimising your lab IT Outside of your laboratories, IT support teams use the ITIL framework to improve efficiency and achieve predictable service delivery of IT assets. Modern laboratories have PC-based instruments and systems which are required to comply with GMP rules, such as those established by the FDA and the EMA, for example.

QC Lab Managers should adopt IT best practices, such as those from Westbourne IT, to optimise your lab IT.

As your laboratory becomes more integrated and IT based, so will the tools you need to manage it. Westbourne IT predict that within three years, any laboratory operating at Level 3 or higher of their maturity model below will also be using ITIL framework to resolve IT issues.

Why ITIL? ITIL stands for Information Technology Infrastructure Library and uses four elements - service strategies, service design, service operations and service transition - to ensure IT service providers deliver best practice in a continuous service improvement environment. ITIL exposes the root cause of all reliability issues of your instruments and systems in the laboratory.

Is the answer Yes? • Do you understand what is happening

with IT systems’ reliability, instrument IT status and Windows 10 upgrade in your QC Laboratory? • Are you certain that don’t get the same IT issues repeating themselves? • Do you have a dashboard on a TV monitor

in your laboratory showing status of testing? • In a multi-lab environment, do you use your IT engineers effectively and could some work be done remotely? If the answer is ‘No’ to any of these questions then Westbourne IT is ideally placed to support you deploying these practices so you can expedite the resolution of IT systems, applications and instrument issues and achieve increased operating efficiencies. Contact James Symington to discuss how Westbourne IT can achieve increased operating efficiencies in your Laboratory IT.

For more information, contact: Westbourne IT The Atrium, Blackpool Business Park, Cork Tel: (021) 4314310 www.westbourneit.com Contact details: James Symington Westbourne IT predict that within three years, any laboratory operating at Level 3 or higher of their maturity model will also be using ITIL framework to resolve IT issues.

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Email: James.symington@westbourneit.com

Irish PharmaChem | Industry Buyers Guide 2022


Only .01% of all drug candidates entering clinical trials will reach the market. Budget. Capacity. Technical knowledge. These are just some of the obsticals that can stand in the way of your biologic’s market approval. Are you prepared for them? With Charles River supporting 85% of drugs approved by the FDA in 2019, leverage our experience and expedite your time to market. We can provide the services, capacity and know-how that can help you bring your therapies to those who need them most.

Improve your odds at criver.com/biologics.


Laboratories & Analysis

Technological additions highlight Ballina upgrades at Charles River

A host of specialised and advanced equipment at their Ballina facility means that Charles River Laboratories are helping their customers to expedite new drugs and therapies to market. 74

Irish PharmaChem | Industry Buyers Guide 2022


Laboratories & Analysis

With innovative equipment and expanded lab capabilities, Charles River Laboratories are helping their customers to expedite new drugs and therapies to market. Since its establishment in 2018, Charles River Laboratories’ analytical laboratory in Ballina, Co. Mayo, has doubled its laboratory footprint. The addition of new laboratory space has enabled the company to bring in specialised and advanced equipment, such as the Maurice system from Protein Simple, PDA, CAD, and ELS detectors, and Droplet Digital PCR (ddPCR) methodology. To better serve their customers, they also offer same-day sample delivery and/ or collection when scheduled in advance (available to/from Ireland/UK). Additionally, they are working on establishing labs to support Biosafety Level (BSL) 3, which will be qualified and ready for use in late Q1, 2021. Their enhanced lab capabilities support QC release testing, in addition to early-stage testing, to promote purification efficiency, formulation development, and the quantification of stabilisers for drug development.

The Maurice system The Maurice system is a proven innovation in capillary electrophoresis (CE) technology. It allows for the automated protein profiling of products either by size (CE-SDS) or by charge (cIEF). The cIEF and CE-SDS analyses can be used for a wide variety of products, such as mAbs, ADCs, vaccines, or virus-like particles. Maurice employs ready-to-use cartridges and analyses samples either directly from vials or from a 96-well plate. It produces pI and charge heterogeneity data in less than 10 minutes and size-based CE-SDS data in 35 minutes, reducing testing time significantly. The team at Charles River strives to anticipate the needs of their clients, and have invested in a number of new detectors which supplement and add to the applications of their HPLC instruments (e.g., PDA, ELS, and CAD). These detectors facilitate the quantification of stabilisers, such as EDTA or polysorbate 80, which may be added to drug products.

Charles River Laboratories employ more than 17,000 people worldwide, operating more than 90 facilities in over 20 countries across the globe. or large sample. It is a useful application for products relating to gene therapy, which is rapidly gaining ground. The field saw a 32% increase in venture funding in 2019. In addition, Charles River Laboratories have recently introduced water testing capabilities to their analytical laboratory, which complements their well-established and highly experienced microbiological testing function. They can test WIFI, purified water, and sterilised water to USP, EP, and JP. Some of the tests they

PURPOSE

METHODS

Physicochemical Characterisation and Identity Confirmation/ Comparability

HPLC/UPLC

Concentration/ Strength/Recovery/ Solubility

Total protein assays (UV, colorimetric)

Potency/Relative Binding/Activity

ELISA

SDS-PAGE CE-SDS Western Blot

HPLC Ion Chromatography

Moisture content Osmolality Conductivity

Charles River Laboratories’ enhanced lab capabilities support QC release testing, in addition to early-stage testing, to promote purification efficiency, formulation development, and the quantification of stabilisers for drug development.

About the company: Charles River Laboratories are passionate about their role in improving the quality of people’s lives. Founded as a one-man operation in 1947, they currently employ more than 17,000 people worldwide, operating more than 90 facilities in over 20 countries across the globe. Their customers includes the world’s foremost pharmaceutical, biotechnology, Irish PharmaChem | Industry Buyers Guide 2022

Analytical methods Their current analytical methods include the following:

Drug Product Appearance Properties (Liquid and pH Lyophilised forms) Particulates

Pioneering technologies Establishing new and pioneering technologies is one of the primary goals in Charles River Laboratories’ quest to help their clients bring new drugs and therapies to the market. They have recently added ddPCR applications to their service portfolio, which can detect and precisely quantify various types of DNA and RNA alterations, using either a very small

can perform include TOC, pH, appearance, conductivity, and nitrates.

Safety

Endotoxin content

Water Testing

WIFI Sterilised and Purified water to EP, USP and JP

For more information on these assays and what they can do for your programme, or if you’d like to know more about the capabilities of Charles River Laboratories’ Ballina facility, please email askcharlesriver@crl.com.

agrochemical, government, and academic organisations, who avail of their research, discovery, safety and efficacy, clinical support and manufacturing skills. Indeed, Charles River supported the development of more than 80% of drugs approved by the FDA in the last three years. For more information, visit www.criver.com.

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Calibration

CalX: delivering world class calibration services According to engineers.com, the average engineer spends 2.7 hours per week reading content on mobile devices, so we’re not going to bore you with the long list of reasons why you should consider CalX. “We just want you to know that we provide our services to a cluster of the world’s biggest life sciences, biopharmaceutical and medical technology companies in Ireland and we want you to consider us should an opportunity arise,” notes Willie McMahon - Co-owner & Director of Sales and Marketing at CalX, who were awarded Employer of the Year 2021 by Generation Apprenticeship.

Highly skilled and flexible team “We are experts in the fields of calibration and asset management,” explains Kevin Davis, co-owner and Director of Operations. “We will seamlessly integrate our powerful management software and highly skilled and flexible team into whatever your facility requirements, people and processes demand.” CalX’s success to date is built upon the skills and talent of their people and their experienced management team, as Kevin stresses: “We don’t make promises we can’t keep.” For more information, contact CalX on 0818 250 250 or email info@calx.ie.

Calibration Management & Instrument Sales Experts

0818 250 250 76

www.calx.ie

sales@calx.ie Irish PharmaChem | Industry Buyers Guide 2022


API’S, INTERMEDIATES & HPAPI’S

SK pharmteco: your global partner SK pharmteco’s mission is to partner with its customers to develop and reliably deliver pharma products through manufacturing and technical excellence. SK pharmteco was established in January 2020 to become the single customer-facing team comprised of SK biotek Korea, SK biotek Ireland, AMPAC Fine Chemicals and AMPAC Analytical, providing their customers a broad portfolio of offerings. In March 2021, Yposkesi was added to the SK pharmteco family, allowing them to enter the Cell and Gene Therapy market. This creates substantial market synergies by combining the highly complementary assets and expertise of these companies, further enabling SK pharmteco to provide the highest quality services to its customers. SK pharmteco is a wholly owned subsidiary of the South Korean conglomerate SK Inc., a global leader in energy, chemicals, and information technology.

Global support network With almost 1,000m³ of small molecule manufacturing capacity globally, across three continents, they have the capacity to manufacture API’s, intermediates and HPAPI’s from grams to multi-tons across the full product lifecycle. With 5,000m² of viral vectors capacity in the heart of Europe, they have the capacity to handle process development to commercial launch of all your gene therapy requirements. SK pharmteco is here to serve all your small molecule and viral vectors needs. “SK pharmteco’s mission is to partner with our customers to develop and reliably deliver pharma products through manufacturing

Irish PharmaChem | Industry Buyers Guide 2022

and technical excellence with an agile and happy workforce, committed to safety, quality, and innovation,” notes Dr Aslam Malik, CEO, SK pharmteco. “Our vision is to be the most trusted global partner in the manufacture and testing of medicines. We accomplish this by reliably delivering pharmaceutical products that benefit patients and communities around the world. “Our seven facilities across a global footprint, are all state-of-the-art plants and laboratories with a strong technology toolbox that is second-to-none and run by our talented workforce of over 1,500 employees.”

Support from development to launch Working with SK pharmteco as a small molecule or viral vector CDMO ensures support from development to launch to commercial manufacturing. “Despite our growth, our values are steadfast and are the pillars our growing business is built on,” explains Dr Malik. “We value the relationships we have with our customers, employees, and suppliers. It is a relationship that is built on respect and relies on clear expectations, communication, and trust.” Using scientific and technical understanding, practical experience, and commitment, SK pharmteco put themselves in their customer’s shoes, understanding the long, complex journey they are on, and applying a sciencedriven, risk-based approach at every step.

An extra sense of security The company’s size offers an added sense of security, knowing they are globally certified in cGMP and are regularly audited by the FDA and leading regulatory authorities, having not

only the resources, expertise, capacity and capability, but also long-term viability to form lasting relationships and bring multiple projects to market. “We are a team Dr Aslam Malik, CEO, who provides both SK pharmteco. consultancy and guidance through the clinical development pathway, focusing precisely on every step but never forgetting the end goal,” Dr Malik notes. “We are a team that offers a partnership rather than a supplier relationship, committed to work with our customers and watch their product as if it were our own, with a track record of producing some of the world’s most recognised drugs over the past few decades. “For a partnership to work, we must share similar values, clear lines of communication and regular updates to foster trust between our customer, the innovator, and us the CDMO. We believe in a ‘one team’ approach, not just internally across multiple geographies, ensuring teamwork, open lines of communication and multi-disciplinary collaboration, but externally with our customers. The sense of ownership is a proud facet of SK pharmteco’s culture.”

Impressive quality record Their quality record isn’t just about passing an audit, but it is about building quality into everything they do, as Dr Malik notes, “it is a part of our DNA”. The same goes for safety. Indeed, SK pharmteco’s slogan is ‘Safety first, and Quality always!’, the CEO reveals: “Our reputation depends on it.” SK pharmteco’s entrepreneurial spirit means they are constantly looking for new ways, services, and capabilities to enhance their offering to customers. “Our ambition is to be a leading integrated development and manufacturing partner for the global pharmaceutical market, meeting all pharma needs,” Dr Malik concludes. “If you are looking for a CDMO specialising in Viral Vectors, High Potency APIs, Continuous Processing, Energetic Chemistry, Controlled Substances, Chromatography, or simply a partner that offers a secure development pathway for your NCE or commercial product, we would be delighted to work with you.”

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Chemicals

Dachser Ireland Chem Logistics: Chemicals in safe hands

The chemical industry is one of the most successful and competitive industries there is, supplying virtually all other sectors with crucial intermediate and end products as well as solutions. This is made possible by high production standards, comprehensive infrastructure, and tailored logistics, with a clear focus on reliability, quality and safety. From clothing fibres to detergents, fertilisers, paints, plastics, and adhesives, chemistry shapes our life and work like no other branch of industry. With its diverse processing and manufacturing activities, the chemical sector is one of the most competitive and successful industries in the European Union.

Dachser Ireland Chem Logistics has been a market leader in chemical storage and distribution for over 30 years, with its own European transport network. terms, we want to create the perfect compound solution for our customers.” In 2020, Dachser Chem Logistics handled some four million shipments weighing 3.4 million metric tons, including 1.25 million dangerous goods shipments weighing 457,000 metric tons. With its global land, air, and sea freight transport network, the logistics service provider embodies process reliability with its defined procedures, reliable transit times, and the capacity it offers. Furthermore, its quality and safety standards far exceed the legal requirements.

A bespoke industry solution Dachser has built up decades of experience as well as a tightly knit transport and warehouse network for packaged chemical products. “Our Dachser Chem Logistics global industry solution combines the standardised network services of one of Europe’s largest groupage logistics providers with very specific, tailored chemical logistics expertise,” explains Michael Mulcahy, Business Development Manager Ireland, Dachser Chem Logistics. “Put in chemistry

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Access to all worldwide sales and procurement markets Dachser has its own European transport network, with daily routes serving Europe, with uniform logistics standards governing all operations. “Through direct transports, platforms, and hub solutions, we directly minimise the handling frequency of sensitive chemical goods,” Mulcahy explains, adding that this categorically enhances both safety and process quality when dealing

with chemical products. “In collaboration with Dachser Contract Logistics, we create comprehensive, integrated logistics solutions using warehouses specially designed for the storage of chemical products,” he notes. “For its part, Dachser Air & Sea Logistics is a one-stop shop that provides fast and flexible access to all worldwide sales and procurement markets.” Holistic, industry-specific logistics concepts are a key pillar of the Dachser Chem Logistics strategy for success. “All transports are handled in the network using efficient, IT-based route planning and uniform standards,” Mulcahy explains. “Our entargo product family has the right solution for every transport requirement.” The Dachser experts also advise customers from the chemical industry on storage and site optimisation, as well as on industry-specific warehousing and stock withdrawal strategies.

Efficient systems and high-quality data “IT underpins the efficiency of our European and global logistics network. Thanks to our standardised, globally connected systems, Irish PharmaChem | Industry Buyers Guide 2022

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Logistics in its element. DACHSER Chem Logistics

Your advantages with DACHSER Chem Logistics Specialised chemical logistics expertise and standardised logistics solutions Automated processes with consistent electronic interface documentation High standards of safety and quality for the chemical industry, assessed according to SQAS A uniform European network Complete transparency with innovative IT systems A high degree of expertise in handling dangerous goods

DACHSER Ireland Ltd. • Dublin Branch Blackchurch Business Park • Rathcoole County Dublin • D24 C796 • Tel.: +353 1 4013333 dachser.dublin@dachser.com • dachser.ie

211112_ANZ_CHEM_Keyvisual_680_IR-EN_210x297_V05.indd 1

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Chemicals

for highly trained specialists along the entire logistics chain. Mandatory standards applicable to everyone involved are also a must. To this end, in its central dangerous goods management system for Road Logistics and Air & Sea Logistics, Dachser has established standardised, internal regulations with defined transport exclusions and risk assessments. Dachser has more than 250 regional dangerous goods safety advisors, who conduct regular internal and external training for over 15,800 employees worldwide each year.

we ensure we provide efficient processes and high-quality data at all times,” Mulcahy says. A pivotal role in this is played by Dachser’s integrated core transport and warehouse management systems: the EDI Centre as a central communication platform, the eLogistics web portal, and the ActiveReport supply chain event management tool. Data security for these systems is certified according to ISO 27001.

Safety first “Safety is always the top priority in all our services,” Mulcahy stresses. This is reflected, for example, in the automated application of all global dangerous goods regulations, the consistent availability and use of load-securing equipment, mandatory vehicle and loading inspections in addition to DGR checks (in accordance with dangerous goods regulations for air transport). Further examples are the provision of rescue equipment and personal protective clothing and equipment, plus consulting on packaging and loading specifically for dangerous goods.

Dachser Ireland Dachser Ireland has been a market leader in chemical storage and distribution for over 30 years. In 2020, the company transported 350,000 shipments, specialising in dangerous goods transportation and warehousing services for customers in the chemical, pharmaceutical, hardware, plastics and packaging industries. Dachser Ireland currently has direct 200 employees, including its own inhouse customs department and a dedicated customer service team to manage all its clients’ logistical requirements. Its warehousing facilities offer 22,000 pallet spaces and form an upper tier COMAH site.

People make a difference The correct handling of dangerous goods calls

For more information, contact: Michael Mulcahy, Business Development Manager Ireland, Dachser Chem Logistics, Dachser Ireland Ltd, Blackchurch Business Park, Rathcoole, Co. Dublin, D24 C796. Tel: (01) 4013325. Mobile: (087) 6995626 Switchboard: (01) 4013333 Email: Michael.Mulcahy@dachser.com Web: www.dachser.ie

Michael Mulcahy, Business Development Manager Ireland Dachser Chem Logistics.

Logistics in its element. DACHSER Chem Logistics

Your advantages with DACHSER Chem Logistics Specialised chemical logistics expertise and standardised logistics solutions Automated processes with consistent electronic interface documentation High standards of safety and quality for the chemical industry, assessed according to SQAS

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A uniform European network Complete transparency with innovative IT systems A high degree of expertise in handling dangerous goods DACHSER Ireland Ltd. • Dublin Branch Blackchurch Business Park • Rathcoole County Dublin • D24 C796 • Tel.: +353 1 4013333 dachser.dublin@dachser.com • dachser.ie

Irish PharmaChem | Industry Buyers Guide 2022 15.11.2021 17:09:05


Logistics

Kuehne+Nagel to open new pharma warehouse

Securely storing and transporting pharma and healthcare related products has a significant impact on patient safety. To support this, Kuehne+Nagel Ireland will open their third pharma and healthcare building in Dublin, and their fourth in Ireland altogether, during Q1 2022. “Kuehne+Nagel continue to invest and support the growing pharma and healthcare industry with a state-of-the-art temperature controlled facility, supporting our clients in delivering world class logistics services,” explains Adam O’Sullivan, Director - Pharma & Healthcare, Kuehne+Nagel Ireland. Their new facility, conveniently situated only five minutes from Dublin Airport and 10 minutes from Dublin Port, is based in Horizon Logistics Park and is ideally located to support the growing pharma and healthcare sector in Ireland. The facility will house 34,000 Euro Pallet positions, segregated loading and unloading gates, direct access to temperature control storage areas and will be a highly secure site. The facility will be HPRA approved, with temperature and humidity monitoring in place. “When engaging with customers, we have a collaborative method, working in partnership to derive bespoke solutions that will work for our customers’ needs. Our strength lies in our ability to offer innovative solutions Irish PharmaChem | Industry Buyers Guide 2022

to customers on a wide range of logistical services”, says Adam O’Sullivan. “As a global logistics partner, Kuehne+Nagel are supporting Ireland‘s growing landscape within the Pharma & Healthcare industry.”

Dedicated to success

Kuehne+Nagel are set to open a dedicated 160,000 square feet pharma & healthcare warehouse in Dublin in early 2022.

Ireland is one of the largest exporters of pharmaceutical products globally, with 50 FDA-approved manufacturing plants across the country. More recently, Ireland has expanded its global hub beyond commercialisation to include innovation, digitalisation and next generation technologies. “Our commitment to the pharmaceutical and life sciences industries continues with the investment being made in Dublin in this new facility,” Adam reveals. “We at Kuehne+Nagel are driving strategic innovation by supporting our customers and shaping the future of logistics.”

About Kuehne+Nagel With over 76,000 employees at nearly 1,400 locations in over 109 countries, the Kuehne+Nagel Group are one of the world’s leading logistics companies. Their strong market position lies in sea logistics, air logistics, road logistics and contract logistics, with a clear focus on integrated logistics solutions. Kuehne+Nagel have operated in Ireland for more than 25 years.

Adam O’Sullivan, Director - Pharma & Healthcare, Kuehne+Nagel Ireland.

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WASTE SOLUTIONS

Providing circular side stream solutions Purifying water and recovering materials with mobile & modular installations InOpSys is committed to providing circular waste or side stream solutions for the chemical and pharmaceutical industry, by building and operating mobile & modular purification installations on the customer site. Using a train of selective technology combinations, InOpSys efficiently closes water and material loops and thus helps the industry reach their sustainability goals by reducing waste and CO2 emissions.

Alternative for linear destruction The costs associated with waste and emissions can thus be reduced and value can be created by the recovery of materials (e.g. precious metals like Pd, Pt, …). InOpSys wants to do better than linear destruction (e.g. incineration) of hazardous side or waste streams in times of water and material scarcity.

Award-winning concept for API removal & metal recovery InOpSys offers solutions to treat water and solvent streams, for: • Active Pharmaceutical Ingredient (API) removal & recovery • Metal removal & recovery (e.g. precious metals) • Micropollutant removal Awards: • Imagine Chemistry Challenge AkzoNobel (2017) • Belgian Business awards for the Environment (2018): first prize • Solar impulse foundation (2021): efficient solution label

One of the running on-site installations which recovers valuable Palladium, used as ahomogeneous catalyst by the customer, and purifies the waste water, closing the loops very high removal rates can be achieved in a more efficient way compared to monotechnology solutions. This also allows InOpSys to remove pollutants in a selective way, leaving easily biodegradable components untouched.

offers its service in a CAPEX-free way. InOpSys finances the installation via a payper-use model, which spares customers an investment which is not interesting enough according to their internal return on investment guidelines.

CAPEX-free service

Contact details

The customers are unburdened as InOpSys takes ownership from start to finish, and

www.inopsys.eu • info@inopsys.eu +32 (0)495 653 821

Selective and very high rate of removal InOpSys uses a decentralised model, creating installations on-site, close to the side stream source. This allows working with unmixed and well defined side streams, and avoids transport as a plus. InOpSys is a one-stop shop, because they do not focus on one single technology, but on a hybrid combination of different technologies. Thanks to this “relay team” of technologies,

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Providing circular side stream solutions Purifying water and recovering materials with mobile & modular installations InOpSys is committed to providing circular waste or side stream solutions for the chemical and pharmaceutical industry, by building and operating mobile & modular purification installations on the customer site. Using a train of selective technology combinations, InOpSys efficiently closes water and material loops and thus helps the industry reach their sustainability goals by reducing waste and CO2 emissions.

Award-winning concept for API removal & metal recovery InOpSys offers solutions to treat water and solvent streams, for: • Active Pharmaceutical Ingredient (API) removal & recovery • Metal removal & recovery (e.g. precious metals) • Micropollutant removal Awards: • Imagine Chemistry Challenge AkzoNobel (2017) • Belgian Business awards for the Environment (2018): first prize • Solar impulse foundation (2021): efficient solution label

Selective and very high rate of removal InOpSys uses a decentralized model, creating installations on-site, close to the side stream source. This allows working with unmixed and welldefined side streams, and avoids transport as a plus. InOpSys is a one-stop shop, because we do not focus on one single technology, but on a hybrid combination of different technologies. Thanks to this “relay team” of technologies, very high removal rates can be achieved in a more efficient way compared to monotechnology solutions. This also allows InOpSys to remove pollutants in a selective way, leaving easily biodegradable components untouched. CAPEX-free service The customers are unburdened as InOpSys takes ownership from start to finish, and offers its service in a CAPEX-free way. InOpSys finances the installation via a pay-per-use model, which spares customers an investment which is not interesting enough according to their internal return on investment guidelines.

One of the running on-site installations which recovers valuable Palladium, used as a homogeneous catalyst by the customer, and purifies the waste water, closing the loops

Alternative for linear destruction The costs associated with waste and emissions can thus be reduced and value can be created by the recovery of materials (e.g. precious metals like Pd, Pt, …). InOpSys wants to do better than linear destruction (e.g. incineration) of hazardous side or waste streams in times of water and material scarcity.

Contact details www.inopsys.eu • info@inopsys.eu +32 (0)495 653 821

circular chemistry can save the world. we believe in circles. we believe in circles.

circular chemistry can save the world. advantages.

advantages.

advantages.

• Reach sustainability goals • Reduce waste and associated costs • Create value by recovery of material (e.g. precious metals like Pd, Pt, …) • Reduce handling & transport of hazardous material • Reduce CO2 emissions

we offer.

circular chemi can save the w

SELECTIVE REMOVAL

• Circular economy solution • CAPEX-free concept • One-stop shop • Selective removal of pollutants • Ownership from start to finish

www.inopsys.eu

Don’t accept the status quo


Chemical Solutions/Technical Services

Chemifloc: chemical solutions for industry

The Chemifloc Group is a wholly Irishowned company, dedicated to the supply of chemical solutions to industry. Water and wastewater treatment solutions are provided via its Chemifloc and Chemilab operations and industrial bulk chemical solutions via its GI Chemicals DAC operation. Established 40 years ago, the Chemifloc Group has evolved from a water treatment chemical provider with five staff members to a highly experienced chemical solutions provider with over 70 personnel. Key to the company’s growth has been its staff, whose work ethic, safety culture and commitment has enabled expansion and new product offerings as needed to serve industry today. The company is fully compliant with all Health and Safety, Environmental and Quality standards currently in place and, to this end, maintains all relevant ISO certifications for its business, including ISO 9001, ISO 14001 and ISO 45001.

€10 million investment The Group has facilities in both Shannon and Foynes Port. Both facilities continue to evolve, with an extensive capital programme of projects seeing over €10 million invested during the last four years in the automation of processes and increased storage capacities, as well as expanding and advancing its capability to continue to provide a safe working environment and meet the sustainability challenges of the future. Logistics is also key to the success of Chemifloc Group. Investment in its fleet and drivers ensures the company can provide an excellent service to its customer base. With a dedicated tanker and rigid truck fleet, prompt deliveries to customers are guaranteed. Chemical solutions manufactured by Chemifloc facilitate the delivery of potable drinking water to homes and businesses and enables wastewater to meet the stringent

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Chemifloc Group provides specialist chemical solutions and technical services for multiple applications and use in industry. environmental standards in force today. Supported by the technical expertise of the Chemilabs team, this also means continuous optimisation of current processes and the capability to provide support services for Research and Development projects for the future.

Chemical solutions Chemifloc manufactures a full range of chemical solutions for the water and wastewater treatment process, including the following applications:

• Coagulation/Flocculation - Aluminium Sulphate solutions (ALUM) - Polyaluminium Chloride (PACL)

- Ferric Sulphate

- Ferric Chloride

- Ferric Aluminium Sulphate

Disinfection

- Sodium Chlorite

- Sodium Hypochlorite solutions

PH Correction

- Sodium Hydroxide solutions

- Sulphuric Acid Solutions

Odour and Septicity

- Ferric Nitrate

- Sodium Nitrate - Calcium Nitrate

Polyelectrolytes and specialist chemical solutions In addition, Chemifloc offers a full range of Polyelectrolytes and specialist chemical solutions for the treatment of foaming, sludge bulking and nutrient problems. These solutions are supported by its Chemilabs operation to ensure they are correctly applied. Chemilabs offers a full range of technical services to support its chemical solutions offerings, as well as a range of laboratory services for customers that include: • Chemical analysis of water and wastewater streams; • Biological analysis of water and wastewater streams; • Jar testing to aid flocculation solutions; • HPLC testing to determine detailed chemical compositions; • R&D projects.

Industrial bulk chemical solutions GI Chemicals focuses on the supply of industrial bulk chemical solutions in road tanker format to Irish industry. Industrial chemical solutions provided include: • Sodium Hydroxide solutions; • Sulphuric acid solutions; • Caustic potash solutions; • Hydrochloric acid solutions. Chemical storage is in Foynes Port, with large inventories maintained and a fully ADR compliant fleet available to meet all customer needs. Chemical supply is by ship ex-Europe direct to Foynes Port, with contracts in place with large European suppliers to ensure the security of supply. The Chemifloc Group has the capability to develop chemical solutions to meet customers’ specific requirements. The combination of manufacturing capability, industry knowledge and technical expertise allows the Chemifloc Group to innovate and react to customer requirements. For more information, visit www.chemifloc.ie. Irish PharmaChem | Industry Buyers Guide 2022


The Chemifloc Group Irelands largest indigenous Chemical Solution provider to the Water, Wastewater Treatment and Manufacturing Industries

ISO 9001.2015 and IBEC certified, the Group has operations located in Shannon and Foynes

Supplying to industry the following: Flocculent and Coagulant aids for water and waste treatment processes Odour and Septicity control chemicals Disinfection chemicals PH correction chemicals

• • • •

Contact us at: info@chemifloc.ie

Supplying to industry the following: Chemical analysis Microbiological analysis Jar testing HPLC testing of solutions

• • • •

Contact us at: info@chemilab.ie

Supplying to industry the following: Caustic Soda solutions Sulphuric Acid solutions Hydrochloric Acid solutions Caustic Potash solutions All bulk formats catered for all industry sectors

• • • • •

Contact us at: info@gichemicals.ie

Chemifloc Group Smithstown Industrial Estate, Shannon, Co. Clare., V14 VY67 Phone: +353-61-708699 Website: www.chemifloc.ie www.gichemicals.ie


Raw Materials

Maintaining raw material supply during a global pandemic Paul Power, Strategic Sourcing & Supply Chain Executive, discusses how NCC are building flexibility and responsiveness into a supply chain during a global pandemic. Like many in the pharmaceutical industry, we are proud that we’ve been able to mobilise our expertise and contribute to the global response of the pandemic. Working closely with our customers, we have developed supply chain solutions throughout the crisis. There have been unique challenges that have arisen relating to sourcing and supplying chemicals during this period. Ensuring that these materials arrive at their destination on time, and in full, continues to be a significant challenge. There is no supply chain without product and as a result, this has placed procurement and logistic departments under considerable strain to ensure that the supply of raw materials continues without any interruption. As a member of the sourcing & supply chain team at NCC, I have seen first-hand the chaos that the global pandemic, coupled with the intensifying shipping crisis, has caused across many long-established supply chains. NCC have focused on working closely with our clients throughout this period and have proven it is possible to effectively operate in an extremely turbulent environment. The investment from ourselves, our logistic partners and our clients has shown massive return in maintaining flexible and resilient supply chains that continued to operate without interruption and avoid downtime. The NCC approach has always been that we become a complete sourcing and logistical partner for our customers, effectively becoming an extended part of our customers’ procurement & sourcing department.

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Addressing the key challenge The key challenge this year was keeping our customers supported with continued access to essential materials, while also allowing them the required flexibility in their material requirements planning throughout the year. One example is outlined in the case study below.

The challenge: We approached our customer, a well-known global pharmaceutical company, in 2020 when they had difficulties in supplying their production plant with large quantities of raw materials. Their plant output consistently responds and adapts to the requirements of the market. Several products are manufactured on-site and following monthly sales and operation planning meetings, campaigns can change significantly. The main challenge was to ensure that there were always raw materials available to keep production running without any downtime but to also accommodate a pivot in client strategy.

Our approach: We addressed the requirements of our customer by ensuring that a managed quantity of safety stock was always available. This means that raw materials were available on call when required by our customer, with NCC managing all touch points until delivery. The key objective was to allow the customer’s supply chain to adapt to new market challenges without any delays to production.

Safety stock reports were issued regularly to the customer, highlighting each material we had in stock, its quantity, or any material in transit and its current location. We also provided market information on each material supplied and took time to discuss if the strategy needed to be tweaked to keep risk to a minimum each month, based on emerging information. This allowed the customer to know clearly what changes NCC could accommodate for them at any moment in time, without the need to make specific inquiries, while also maintaining a dynamic response to the changing supply chain situation.

Result: The result of our approach has meant that our customer has received all raw materials delivered on time and in full throughout the entirety of 2021, with as little as 24 hours’ notice required for volumes up to 72 metric tonnes. This has meant that there has been no production downtime at any stage.

Expertly managed end-to-end supply chain solutions With over 50 years of experience, we provide our customers with end-to-end supply chain solutions. Regardless if the materials are sourced locally or globally, our goal is to provide full management and traceability of supply at every stage. There is no ‘one size fits all’ solution, but through consistent and open collaboration, NCC will optimise the efficiency of your supply chain, saving your organisation time, money, and resources. For more information, call (01) 6131400 or email hello@ncc.ie. Irish PharmaChem | Industry Buyers Guide 2022


A sourcing partner you can rely on

In times of uncertainty, you need a pharmaceutical sourcing partner that not only has the know-how and in-house capability but will always go the extra mile. NCC is that partner. With over 50 years of sourcing excellence, we ensure that our customers receive consistently compliant products, solutions, and services. With full supply chain traceability and the highest global standards, NCC is that essential link in your supply chain.

To learn more about NCC and our approach to sourcing:

T. +353 1 613 1400 E. hello@ncc.ie W. ncc.ie


ToF MEASUREment INSTRUMENTS

Access storage tank level from anywhere With more than 2.2 million installed applications and 50 years of experience, time-of-flight (ToF) measurement instruments are an important component of Endress+Hauser’s portfolio. ToF devices are used in a wide range of applications, and are a reliable solution, even under extreme process conditions, such as high pressure or temperatures and in corrosive or aggressive media. The new generation of Micropilot instruments offers compact design and maximum userfriendliness, as well as application-specific flexibility, to provide solutions for both mobile and stationary plastic tanks. The storage of liquids plays an important role in many industries. Liquid fertilisers or irrigation systems for agriculture, additives as well as cleaning agents for the food industry or liquefiers for the production of concrete are only a few examples. Usually, plastic tanks are used for this purpose. In order to ensure continuous production and prevent downtime, the liquids must always be available in sufficient quantities. This is where level measurement is used. As the number of tanks increase, so do the measurement requirements. The fact that plastic tanks are often located at remote sites and are widely dispersed geographically makes the process even more complex. In more than 80% of all production plants, level measurement is done manually. This type of manual monitoring is both time and cost intensive. So very often, this results in missing stocks only being registered when the tank has already run empty, and the production process has come to a halt. Even increased inventories are in most cases not an alternative due to the storage costs involved. Clearly, a better solution is needed.

to the distance. With a known vessel geometry, the level can be calculated. But the new Micropilot FWR30 offers considerably more. As the world’s first 80GHz wireless IIoT sensor, it combines high-end technology and user-friendly digital services in one costeffective device. The continuously recorded measurement data can be accessed at any time and from anywhere via the device’s cloud connection. Communication is made possible by an integrated SIM card.

The first cloud-connected radar level sensor from Endress+Hauser revolutionises measurement in storage tanks.

Field of application The Micropilot FWR30 can be used for level measurement and inventory management of mobile and stationary plastic tanks. In addition, the tracking of mobile storage tanks is also possible. The free radiating measuring device covers measuring ranges up to 15 metres (50 feet) and temperatures between -20 °C and 60 °C (-4°F and +140°F). Due to non-contact measurement, the Micropilot FWR30 can be used in all liquid media. It works where other measuring principles cannot be applied due to corrosion, abrasion, viscosity, or toxicity, and it can be employed in a variety of industries. For more information, visit www.endress.com/ micropilot-fwr30.

Optimised inventory management: simple from scratch To meet these challenges, Endress+Hauser has developed a solution consisting of a level sensor and software. This solution considerably simplifies the management of stocks in stationary and mobile applications. As with conventional devices, the measurement is based on high-frequency radar pulses. These are emitted by an antenna and reflected by the surface of the stored medium. The travel time of the reflected radar pulse is directly proportional

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For more information visit www. endress.com/micropilot-fwr30 Irish PharmaChem | Industry Buyers Guide 2022


We understand how you are challenged every day to enhance your plant’s safety and performance.

MAXIMIZE + CAPITALIZE You gain more options to fit your needs, build up product quality, increase safety, reduce costs and minimize risks.

Micropilot FWR30 – The cloud connected radar level sensor • Transparency – full and secure access to information on asset and inventory status, from anywhere at any time • Simplicity – from procurement to operations, simplified commissioning, handling and processes • Flexibility – suitable digital services defined by user needs, scalable from Netilion Value via Netilion Inventory to SupplyCare Hosting • Reliability – precise measurements with wireless high-end 80Ghz sensor technology

Do you want to learn more? www.ie.endress.com/fwr30


High-Purity Solvents

Univar Solutions: your solvents supply partner Univar Solutions offer high-purity solvents you can rely on for your pharmaceutical and biopharma production.

Most APIs (active pharmaceutical ingredients) are produced by chemical synthesis from a range of compounds. Highpurity solvents are synthetically distilled organic chemicals, critically important for optimising manufacturing in the API primary pharmaceutical industry. At Univar Solutions, a leader in global chemical and specialty ingredient solutions, distributing pharmaceutical solvents is critical to keep the life sciences and medical industry bolstered during a year of tight supply. Providing higher purity levels, product integrity and guidance on the latest technical requirements help ensure quality control and regulatory compliance. Univar Solutions is a reliable chemical distributor of key solvents, including alcohols, acetone, glycols, ketones and ethers. With purity, safety and efficacy to consider, it is imperative that manufacturers and producers trust the quality of the solvents used in pharmaceutical operations, as well as receive accurate, on-time service, customer support and supply chain expertise. How can Univar Solutions’ solvents distribution infrastructure bring value to the pharma industry’s production and bottom line? In Europe, Univar Solutions holds top accreditations for pharmaceutical ingredient distribution, including ingredient storage, repacking and registration certifications across many of its sites. All facilities meet ISO 9001 quality management system standards and numerous facilities are also accredited to

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Univar Solutions holds top accreditations for pharmaceutical ingredient distribution, including ingredient storage, repacking and registration certifications across many of its sites. various global standards, regulations and API requirements. In addition, Univar Solutions’ operational sites are assessed and audited on a three-year cycle against its own Global Assessment Audit programme.

Unrivalled supply chain network Beyond certifications and meeting industry standards, its pharmaceutical business offers a large supplier network, consistency, vendor access and relationships, supply chain security measures and ready access to solvents and high-quality products. The company serves the growing biopharma and pharmaceutical brand name and generic drug segments. “We offer an unrivalled supply chain network, designed to deliver on the integrity requirements of the biopharma and pharmaceutical markets safely. Univar Solutions

has been certified as an IEA GDP Passport holder, formal certification from the IEA and Life Sciences Ireland, demonstrating adherence to GDP regulations and best practices in safety and quality,” says James Peterson, Global Vice President for Pharmaceutical Ingredients at Univar Solutions. Univar Solutions is also committed to investing in global pharmaceutical expansion and providing commercial excellence to support supply chains.

Proven track record “We have a proven track record of ontime delivery, making Univar Solutions a fast and reliable partner globally for an expansive range of high-quality solvents,” adds Peterson. “Our close relationships with suppliers, our rail cars, our private fleet and our network of distribution centres, all enable us to fulfil solvent needs to the pharmaceutical market at a time where it is needed most.” With the market focus continuing on vaccine production, the shift from brand name to generic drugs, supply chain security and chemical shortages, Univar Solutions is the distributor of choice for pharmaceutical solvents, serving all facets of the medical production chain with a premier portfolio of solvents, APIs and excipients. For more information, visit univarsolutions.com/pharma. Irish PharmaChem | Industry Buyers Guide 2022


END MARKET | REGION

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Temperature Controlled Storage Solutions

Controlling your cold chain

Working in the pharmaceutical industry, you’ll understand the importance of maintaining proper storage conditions for valuable pharmaceutical products. It is one of the key stages in the delivery of pharmaceutical products to the public. However, there are various challenges in maintaining proper storage conditions, due to the complexities of pharmaceuticals, which often require different temperature ranges, and each product must be stored correctly to meet compliance standards.

Temperature stability impact In recent years, there has been a substantial increased demand for temperature control in the pharmaceutical industry, and this has led to more investment in the area to alleviate the risks. The stakes couldn’t be higher when it comes to maintaining a pharmaceutical product’s temperature; in fact, even a small temperature deviation could impact its reliability and integrity. The inadequate storage of pharma products can compromise chemical stability and form impurities, possibly degrading the product. Worryingly, the impact of degradation is invisible, so often the issue can go unnoticed until it causes issues once it is administered. Improper storage can also alter a medication’s physical property and these tiny physical changes, which include changes in colour, indicate that the product may not be as effective as it should be.

Temperature control solutions Pharmaceutical companies usually rely on industry experts to provide the cold chain solutions to ensure products are stored appropriately. Dawsongroup | TCS Ireland’s modular rooms are often the best and least

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Choosing the right cold chain solutions provider gives the pharmaceutical industry peace of mind, writes Aidan McCauley, Managing Director at Dawsongroup | TCS Ireland. disruptive option in delivering consistent and reliable cold chain solutions to the pharmaceutical industry. For over 22 years, Dawsongroup has been supplying modular temperature control solutions, through continuous R&D and working closely with our strategic partners. We offer our clients rooms with the latest technological advancements, developed after exhaustive consultation and experience in the pharmaceutical industry. Our range includes modular cold rooms, shock freezers, stability rooms, cleanrooms, hot rooms and ATEX storage. All pharma units are constructed using LPCB approved Polyisocyanurate (PIR) insulation materials, which give a guaranteed 30-minute fire resistance. Stringent GMP/GDP codes are applied to each design, installation, and aftercare support. Dawsongroup rooms typically return 25% less operating costs than other commercial units, and with low noise emissions, the system represents the best in modern technology and environmental savings. Pivotally, the rooms feature a dual refrigeration system, providing 100% backup, with auto switch-over in the unlikely event of a fault occurring. The refrigeration system also reaches a wide temperature range (-40°C to +45°C), thus allowing the conservation, freezing, cooling, stabilisation and testing of medicines, vaccines, and any other type of pharmaceutical products.

Peace of mind As a market leading temperature control solutions provider, we’re responsible for delivering innovative and reliable solutions

Dawsongroup has been supplying modular temperature control solutions for over 22 years. that are designed to meet industry standards, which is why we have heavily invested in the technology and innovation of our solutions. We understand that this is the reliability the pharmaceutical industry demands, to provide the highest possible guarantee that each valuable pharmaceutical product is stored at the correct temperature for continued peace of mind. For more information, contact Dawsongroup | TCS Ireland Phone: (045) 448810 Email: contactus@dawsongroup.ie Website: https://dawsongroup.ie/

Irish PharmaChem | Industry Buyers Guide 2022


ai163472365914_Print_Dual refrigertation TCS Advert ireland.pdf

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Dawsongroup TCS Ireland

Market leading rentable temperature control solutions you can rely on with dual refrigeration systems and auto-switch in the event of a fault, ensuring your high value products are never exposed to unwanted temperatures. C

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30-minute Fire Resistant

Data monitoring and full temperature mapping

LPBC approved and MHRA compliant

Stability Chambers | Atex Storage | Humidity Control | Hot Boxes | Test Chambers | Blast Freezers | -70ºC Freezers Reach In | -40ºC Freezers | -20ºC Freezers

Book your free consultation dawsongroup.ie | +353 (0)45-448810 | contactus@dawsongroup.ie *Compared to other commercial units


Custom Buffers / Chemical Blends October 2021 saw Limerick-based A&C Bio Buffer being acquired by Aceto, the growing leading provider of specialty materials for life sciences and advanced technology end markets, offering Irish and global pharma and biopharma customers greater access to custom buffers and chemical products. Also in 2021, Aceto acquired the rest of the A&C Group, including two GMP manufacturing facilities in Montreal, Canada, which add to their impressive GMP manufacturing capabilities.

A&C now part of Aceto

A&C Bio Buffer: outsourcing and chemical blends manufacturing Buffer liquids can constitute an expensive bottleneck in biopharmaceutical downstream processing. Making these fluids in-house requires regulatory oversight, quality management and dedicated space, equipment and staff for buffer preparation and handling. A&C Bio Buffer manufacture buffers on their clients’ behalf in their state-of-the-art ISO 9001:2015 certified facility in Co. Limerick, opened in 2018. A&C Bio Buffer offer costeffective, flexible and tailored solutions for any buffer outsourcing and cleaning solution needs, providing full release testing and supporting documentation.

A&C Group: high quality standards on a global scale The A&C Group, now known as A&C by Aceto, solve customers’ technical, product and regulatory challenges through GMP custom ingredient development, manufacturing, and packaging in the pharmaceutical and biopharmaceutical sectors. They maintain offices and GMP production facilities in North America and Ireland. The A&C Group have been servicing the life sciences industry since 1966 and are a service-driven organisation, finding unique solutions to customers’ GMP challenges. The A&C Group are renowned for their high-quality standards. This is demonstrated through the numerous quality certifications they hold, including ISO 9001:2015, EXCiPACT (GMP and GDP), Drug Establishment License for manufacture of APIs, and FDA and Health Canada audited.

Limerick-based A&C Bio Buffer was acquired by global materials provider Aceto in 2021. Specifically, Aceto’s recent acquisitions allow them to produce: • GMP custom buffer and chemical blend products; • active pharmaceutical ingredients (APIs); • GMP excipients; • regulatory starting materials; • pharmaceutical intermediates; • lab chemicals; • specialty chemicals. The company also offers R&D services, analytical services, and technical services, which complement Aceto’s proven leadership in chemical sourcing, quality, and supply chain. Aceto’s global operations, including a significant footprint in Europe, North America, China and India, enable their deep worldwide manufacturing, sourcing and regulatory capabilities. Aceto are well-positioned to innovate

new solutions, ensure quality and customise products to meet customers’ specific needs. Their expanded manufacturing and R&D capabilities, combined with decades of global sourcing expertise, are especially valuable now that supply chain management is a critical strategic issue for companies worldwide. “With the acquisition of A&C, Aceto have materially expanded our self-manufactured and custom product offerings in the vaccine and biopharmaceutical space,” said Gilles Cottier, Chief Executive Officer of Aceto. “Across all of our recent acquisitions, Aceto can now offer customers an extensive selection of highest quality and competitively priced products and services to help customers secure and optimise critical supply, as well as bring new products to market globally.” For more information, visit www.aceto. com and www.acbiobuffer.com or email BioBufferSales.AC@aceto.com.

About Aceto In just two years, Aceto have made six acquisitions of firms with expanded manufacturing, R&D and portfolio offerings, transforming the company into a global supplier of critical raw materials with a robust manufacturing footprint. With business operations in 10 countries and seven manufacturing plants worldwide, Aceto manufacture and supply over 3,000 chemical compounds used principally by the biopharmaceutical, nutraceutical, agricultural, cosmetic and specialty chemical industries.

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A&C Bio Buffer manufacture buffers on their clients’ behalf in their state-of-the-art facility in Co. Limerick, opened in 2018. Irish PharmaChem | Industry Buyers Guide 2022


A&C is a GMP manufacturer of excipients, buffers, process solutions, cleaning solutions and a select number of APIs. At our ISO 9001:2015 certified manufacturing plant in Limerick we offer: GMP standard and custom buffers Water for Injection GMP excipients manufacturing GMP chemicals blends GMP packaging and repacking

In 2021, the A&C Group was acquired by Aceto which is a global supplier of specialty materials to the Life Sciences industry with 5 manufacturing plants globally and a portfolio of more than 3,000 chemical compounds.

www.acggp.com

www.aceto.com

+353 52 614 8880

euro.ac@aceto.com


Ingredients

Barentz offers broad ingredients portfolio

Barentz represents some of the world’s foremost producers of excipients, APIs, nutraceutical, and BioPharma ingredients.

Ingredients distributor Barentz offers pharmaceutical manufacturers a range of ingredients to suit every application. Barentz is a global life science ingredients distributor specialising in human nutrition, pharmaceuticals, personal care and animal nutrition, creating unique synergies across all fields of expertise. Founded in 1953, Barentz is now present in over 60 countries, with a global team of more than 1,500 local experts, dedicated to 21,000 customers and with a turnover of €1.4 billion. Driven by the powerful blend of entrepreneurship, partnership, and knowledge, Barentz creates and delivers ‘Always a better solution’. Barentz acquired Forum Products in 2011 and rebranded it as Barentz Ireland in 2019. Barentz’s success lies in building long-lasting relationships with suppliers and customers, based on trust, transparency, and reliability, where going the extra mile to provide customer satisfaction is part of the company’s DNA.

Barentz has a skilled team of technical sales managers offering a broad portfolio of

 Local, regional & central (HUB)

Excipients for Nutraceuticals Oils, fats, and waxes Preservatives Emulsifiers Permeation enhancers

APIs

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Barentz offers clients:  In-house technical scientists, providing specialist advice on ingredient choices and functionality;  Local sales office, staffed with technical

FILLERS TASTE MASKING Binders Flavours Diluents Sweeteners Disintegrants Solubilisers Glidants Sugars Lubricants Controlled Release

Anthelmintics Diuretics

Why Barentz is the right business partner for you

High quality ingredients and technical expertise

A broad portfolio of premium quality and high-performance ingredients

Antihypertensives Antiarrhythmics Sedatives

ingredients to suit every application. They are on hand to select the optimum combination of ingredients to assist with solving the formulation challenges and manufacturing demands of customers. Barentz represents some of the world’s foremost producers of excipients, APIs, nutraceutical, and BioPharma ingredients, including Roquette, Meggle, Dr Paul Lohmann, IFF, Ajinomoto, Abitec, Ohly, IPS & Moehs. Barentz supplies customers producing innovator pharma, generics, OTC, CMOs/CDMOs, BioPharma, medical devices, nutraceutical, and healthcare supplements.

Mineral salts for Atypical & Speciality APIs

sales managers and support staff; warehousing;  Combined order management and

sampling service with harmonised ERP/ CRM systems;  Fully implemented QA systems, ISO-

9001:2015 and GDP certified.

For more information, contact Barentz Ireland Ltd, Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin, D24 XN60 Tel: (01) 4039518 E-mail: pharmaireland@barentz.com Web: www.barentz.com Irish PharmaChem | Industry Buyers Guide 2022


Always a better solution. At Barentz, we have made it our business to excel in delivering premium quality and high performance excipients, APIs & nutraceutical ingredients – sourced and provided by our partnered suppliers. Customers greatly value our deep technical knowledge and extensive product portfolio, our capability to manage quality throughout the entire supply chain and our local presence. Contact our Dublin sales office at pharmaireland@barentz.com or call us at + 353 1 4039518.

www.barentz.com

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Engineering

Complex engineering solutions from Foltech

Foltech Engineering, based in Cork, are at the forefront of complex engineering, procurement, construction and maintenance projects for commercial clients around the country. Since their inception in 2009, Foltech Engineering have become one of the key suppliers for the pharmaceutical and manufacturing sectors in Ireland. They have developed and nurtured a highly skilled team with the expertise and experience to meet any client requirements and deadlines. Currently, Foltech employs 46 staff and look forward to growing this number in 2022. Their recent investments include a new HD Plasma machine, CNC brake press and new Orbital welding plants with capacity up to 6” pipe. Mechanical turnkey projects and fabricated high end stainless or Hastelloy units with electropolish finish are at the core of their business.

Meeting high standards and specifications

Foltech Engineering are a local engineering company, providing global solutions to the pharmaceutical and manufacturing sectors.

The experience gained in the pharma and manufacturing industries over the past 12 years allows the company to offer a very comprehensive service and meet clients’ high specifications that this area of the industry demands. They carry out all their own in-house design and engineering drawings in 2D and 3D formats using the latest Autodesk 3D software and Solidworks drawing packages. This allows Foltech to present 3D models in a very professional manner to clients before any project kicks off to aid with getting all the details correct before fabrication starts. Foltech are CE 1090 certified in stainless and carbon steel and their welders are qualified in a number of weld procedures, covering ASME and EN standards across a range of materials. They specialise in stainless fabrication to include PED rated equipment, pipework fabrication and installation. With over 15,000 square feet and a controlled division between their stainless and mild steel workshops, Foltech can execute high end stainless fabrication and mild steel simultaneously, without risk of any cross contamination. They also manufacture CE marked pressure vessels in accordance with European Directive 97/23/EC (the PED). All vessels are bespoke and are designed to meet customer specifications with independent design verification, inspection and certification by a notified body.

Professional approach

Foltech’s core business is high end fabricated stainless and Hastelloy equipment.

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“Whether you’re looking to invest in new facilities or the refurbishment of aging equipment, our team at Foltech are committed to delivering the highest quality product, safely, on time, and within budget,” explains John Foley, Director. “Our professional approach to projects has been commended by many clients in the past with our documentation on project meeting clients’ expectation every time.” For any enquires for mechanical projects, fabrication, maintenance, plasma cutting and folding service please email info@foltech.ie call (021) 4639592. Irish PharmaChem | Industry Buyers Guide 2022


www.foltech.ie

Mechanical Contractors - Mechanical Design, Fabrication including Orbital Welding & Installation - Turnkey Projects - Plant & Facility Maintenance - Stainless and Mild Steel Fabrication - Design, Manufacture and Supply of all stainless steel hardware for your manufacturing facilities including PED rated equipment

Our Clients include

Contact Information Call: 021 - 463 9592 Email: info@foltech.ie Web: www.foltech.ie


Waste Management

Indaver: delivering sustainable waste management Indaver operate a solvent recovery platform in Dublin Port. As an international waste management company offering sustainable, cost-efficient and tailored solutions to the large scale industry, Indaver take their responsibility to contribute to a clean and safe planet of the utmost importance. In doing so, they focus on using less primary and fossil feedstocks in order to recover, reuse and recycle materials efficiently. Thanks to their 30 years of expertise and wide range of in-house facilities and processing possibilities with third parties, Indaver offer a solution for each type of waste. Through improved recycling and maximum recovery of energy and valuable components from waste, Indaver are leading the field in sustainable waste management.

Local and international treatment solutions Over the years, Indaver have become an international player in Europe, with facilities and operations in Ireland, UK, Germany, Belgium and the Netherlands. Today, the Indaver Group manages around five million tonnes of waste per annum. With their Wasteto-Energy installation in Carranstown, Co. Meath, they produce the equivalent energy to power 42,000 homes, thus providing a sustainable alternative to fossil fuels. Their solvent recovery platform in Dublin Port also offers opportunities for the industry.

Recycling precious metals from liquids Homogeneous catalysts are precious both to your business and to the environment. Indaver don’t want them to go to waste. With Inda-MP, a state-of-the-art facility located in Antwerp, Belgium, Indaver offer an efficient one-stop-solution to recover precious metals from your liquids, all the way from

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Indaver have introduced a host of safe, innovative and sustainable solutions for waste management.

Indaver’s Waste-to-Energy plant in Carranstown, Co. Meath, produces the equivalent energy to power 42,000 homes, thus providing a sustainable alternative to fossil fuels. logistics until delivery of the refined metals. A large part of these liquids originate from reactions based on homogeneous precious metal catalysts, used in the pharmaceutical industry. The substantial financial and environmental gains from this solution have already convinced several pharmachem companies to start a sustainable partnership with Indaver.

End-of-life plastics, a source for valuable raw materials With their Plastics-to-Chemicals (P2C) installation, Indaver want to develop a safe and sustainable solution for postconsumer plastic waste. Via a depolymerisation process, plastics are converted into high-grade recycled resources like styrene, naftha and waxes for the (petro)chemical industry. With P2C, plastics are broken down all the way to the molecular level. The P2C project is an ambitious and innovative plastics ‘recycling’ solution that will contribute to helping achieve Indaver’s customers’ climate targets.

Investing in the community and biodiversity Indaver support community projects that contribute to the circular economy, climate change, energy-efficient mobility, Irish cultural heritage and many more. For example, their Carranstown Fund Scheme has provided over €2,000,000 to the local community to date. Through this commitment, Indaver encourage people to live differently and to consume more sustainably. In doing so, they take up their social corporate responsibility as an international environmental company and hope to inspire others to do the same. Since biodiversity is an important part of the ecosystem, Indaver guarantee a focus on preserving the fauna and flora in and around their sites and throughout the entire chain.

Irish PharmaChem | Industry Buyers Guide 2022


Recycling of precious metals & end-of-life plastics

Solvent recovery

Local and international treatment

Heat networks for industry & community

The circular economy

Together we make it happen It's all about Sustainable Partnership really. Constant Innovation comes with it. Discover how Indaver can contribute to a cost-effective, CO2-reducing and environmentally friendly waste management.

Contact us by email: info@indaver.ie or call +353 1 6972900. www.indaver.ie

LEADING THE FIELD IN SUSTAINABLE WASTE MANAGEMENT


Logistics & Transport

Ballinlough has evolved from a small service and repair company to offering full temperature controlled transport solutions for the pharmaceutical and biotech industries. Ballinlough was established in 1986 as a small service and repair company for the transport refrigeration industry in the County Roscommon town of the same name. Since then, the company has expanded, taking on the Thermo King dealership in 1992 and today operating from three sites with over 100 staff: their head office in Kingswood, Dublin, the original depot in Ballinlough, and their workshop in Annacarton Bridge, County Cork. Ballinlough offers a considerable portfolio of temperature control transport solutions for the pharmaceutical and biotech industries. The Ballinlough team work with leading companies in the pharmaceutical sector, providing truck, trailer, van refrigeration and efficient lightweight panel insulation. Complementing this equipment, Ballinlough can also offer dual refrigeration systems for 100% back-up, data monitoring with live tracking of temperatures, humidity and vehicle status. Ballinlough offers temperature mapping and probe calibration, with their own GDP Champion on-site. Their engineers will work with you to apply stringent GMP/GDP codes to each application, as well as during supply and throughout aftercare support. This includes qualification and validation support, GAMP data monitoring systems.

End-to-end pharma transport solutions

Quality standards Ballinlough is committed to attaining certification that meets or exceeds customer requirements. Environmental impact is a significant consideration at all of their facilities, which are registered ISO9001, ISO14001, ISO45001. Working alongside its customers, Ballinlough strives to create long-lasting partnerships by focusing on each customer’s individual needs, working to evaluate the customer’s challenges and provide solutions and applications that empower their customers to drive outcomes and meet their goals. Ballinlough’s customers encompass the healthcare, medtech, automotive, retail home delivery, consumer products and food sectors. Ballinlough’s solutions can support e-Commerce, Retail and B2B fulfilment, improve

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efficiency and accelerate your response to changing customer demands, as their expert team design, manufacture, and implement flexible solutions tailored to your business needs, supported by experienced skilled mobile engineers, along with a fully equipped van. “We strongly believe that our level of customer support is unmatched by anybody else, and we are always striving to improve it further,” explains Christian Visser, Business Development & Marketing Executive, Ballinlough. “We carry a full range of critical parts / spares in our stores departments at strategically located sites.”

Thermo King Ballinlough stock a range of GDP Qualified and validated equipment for trailer, truck and vehicle

powered units, as well as ColdCube Thermo King containers, which have been tested following Thermo King GDP validation protocol in line with the GDP guidelines (with tests developed and performed to include ‘worst case’ conditions: ● At temperature ranges +15°C to +25°C; +2°C to +8°C; and temperatures below -20°C; ● Under extreme ambient temperatures from -30°C to +40°C to assure you of your cargo’s safety in extremes of climate; ● Test of door openings, failure mode as a reference for customer’s risk management analysis. To confirm that the refrigerated equipment is performing to specification, tests have been conducted in a temperature-controlled chamber of the industry-certified ETC (Engineering and Technology Center) in Prague. The research and development facility is certified ISO 9001: 2000; ISO 14001 and ISO 18000 and authorised for ATP certification. “We understand that temperature controlled distribution is an essential part of your product’s integrity and ultimately, your reputation,” concludes Christian. “Our mission is to make your life simple; we install, providing 24/7 support to all clients.” Irish PharmaChem | Industry Buyers Guide 2022



reland’s Ireland’s Raw Raw Materials Materials Specialists Specialists

Unit 49, Baldoyle Industrial Unit 49,Estate, Baldoyle Baldoyle, Industrial Dublin Estate, 13, Baldoyle, Ireland Dublin 13, Ireland . +353 1 839 3127 F. T. +353 +353 11 832 839 5746 3127 E. F. info@heterochem.com +353 1 832 5746 E. info@heterochem.com W. www.heterochem.com W. www.heterochem.com

Contact directly our Product Manager Dave Foley on 083-0891204


Work wear Professional work wear is one of the key components for many successful companies. Appropriate work wear can bring great rewards both to companies and their staff in terms of saving costs, looking professional, boosting morale and increasing productivity. Providing a workforce with professional and suitable work attire can also improve the overall security and safety of a workforce, particularly if the company is one which might have a sensitive work environment. The pharmaceutical industry is one such sector, where employees often need to be protected from what can be a hazardous and critical work environment, involving sensitive pharmaceutical products and processes, and where there can be many contaminants, such as chemical substances, as well as hazardous and non-hazardous particles. Thankfully, those working in the pharmaceutical industry all over Ireland can now access the clothing that they need through a garment dispensing machine.

OSL work wear dispenser OSL is a garment dispenser and returns system that has proven indispensable to those working in the pharmaceutical industry. The OSL system gives rapid access to garments necessary to those employed in the pharmaceutical and other similar industries. This innovative product from O’Flynn Medical means that it takes less than six seconds for an authorised staff member, using the correct ID card or similar, to access their garments. Ultimately, it results in minimal disruption to the already pressurised working day. The OSL system is also suited to the distribution of clogs, gloves or other materials. This system requires very little floor surface area, and 1m² is enough to store 240 garments. Another unit can always be added if extra capacity is needed. The benefits include: • Garments are available for controlled distribution 24 hours a day, seven days a week; • Clean garments can only be obtained once used clothing has been returned; • Easy to use 6” touchscreen; • Improved forecasting capability with reports available on usage levels and requirements; • Eradicate the department-led requests for additional inventory and top-ups; • Improvements in stock provision and availability, which can be quantified, while enhancing infection control policies; • An understanding of quality measurement points, such as throughput times, cycle of use, no sales and / or hygiene.

Reducing workwear replacement costs OSL is a worthwhile investment which can provide up to a 40% reduction in usage of work wear textiles or scrub suits by using a credit system that dictates how many garments a staff member can have at any one time, resulting in reduced garment use and simultaneously providing an Irish PharmaChem | Industry Buyers Guide 2022

The OSL requires very little floor surface area, and 1m² is enough to store 240 garments.

Efficient work wear dispenser from O’Flynn Medical •

The OSL garment dispenser from O’Flynn Medical provides rapid access to work wear necessary to those employed in the pharmaceutical industry. audit trail of how often staff members change and launder their garments. This ultimately has large cost savings, as well as ensuring the safety and protection of employees and company processes and products. The machines themselves are quick and easy to fill. Overall, they can reduce work wear replacement costs by up to 90%, making the machine ideally suited to the pharmaceutical industry. “We ensure the OSL assessment and implementation is as easy as possible for companies by getting to know the current process the facility is using and addressing any local concerns prior to a decision being made,” explains Conor O’Flynn, Chief Operations Officer, O’Flynn Medical.

Family-run company Established in 2000 by Tadhg and Anne O’Flynn, and with a staff of more than 30 dedicated professionals, O’Flynn Medical pride themselves

on the quality of products they offer, their attention to detail, and the fast, efficient service for customers. “Our range of quality equipment is amongst the highest quality products on the market, and is designed specifically with efficiency in mind,” Conor reveals. “We also offer a full rental option on our equipment, together with a state-of-theart decontamination service and a full service department. Our technical, clinical and sales teams are dedicated to providing excellent backup and support to our customers at all times.” O’Flynn Medical’s team of dedicated professionals include highly trained service engineers, experienced product specialists and excellent office support staff. Continuous staff training and education is of paramount importance in the company to ensure clients receive an excellent product and service, every time.

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Process Data

A smarter approach to processing with Bonner These days, everything is getting smarter. The data we generate every day can now be harnessed to help us live and work in better, more productive ways. This smart technology has entered all aspects of our lives, and the processing industry is no different. However, in Ireland, many factories are still relying on outdated equipment and processes that do not produce usable data; or, if they do, it is often unreliable. Moving to a modern system that collects process data, analyses it and presents it back in an actionable format can save a business considerable time and money. Process information can be transformed into an asset through data acquisition and control applications, allowing factories to streamline production and identify any non-performing processes. This improves a plant’s Overall

Bonner helps customers to unlock the value within their process data. Equipment Effectiveness (OEE) by increasing the efficiency of the equipment or area.

Getting more from your data Bonner specialises in the delivery of bespoke, plant-wide systems that help customers get more out of their data in the most effective way. Whether tackling Energy Monitoring, Condition Monitoring, Predictive Maintenance

or Remote Asset Monitoring, the team designs solutions that best meet the needs of each individual plant. And, as the systems can be integrated with new or legacy equipment, Bonner can create a solution to work for any process, traditional or cutting-edge. Bonner helps customers to unlock the value within their process data, enabling them to make smarter decisions for their business.

We can add the Smart to your factory to help make decisions in real time based on reliable and available data. Factory automation systems including Process Data Acquisition, Condition Monitoring and Energy Monitoring can improve your factory’s OEE by making data intelligence and predictive maintenance part of your process.

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Irish PharmaChem | Industry Buyers Guide 2022


Documentation Solutions

Reduce human error and enhance training TWi is a leading technical writing and TWi’s Solutions information design service provider, offering Information design and technical high-quality, flexible, and scalable communication expertise; documentation solutions for biopharma and Consultancy and support on documentation medical device companies. and information management; User-focused approach to documentation development; Your Challenges Flexible, scalable, and customised service Producing effective CAPAs to improve offerings that can integrate with your your Human Error Reduction (HER) teams; programme; Tailored training in technical communication skills and strategies. Reducing ambiguity and unnecessary

• • • •

• • •

complexity in SOPs, BMRs, and IFUs that may lead to confusion and human error; Creating user-friendly product information documents and user manuals;

Achieving resource efficiencies, while maintaining quality and ensuring regulatory compliance;

Developing the skills of your team.

The Results

• • • •

High-quality CAPAs and reduced human errors; Standardised and user-friendly SOPs, BMRs and IFUs; Enhanced documentation quality, consistency, and usability; Greater operational efficiency, saving time and resources.

Partner with TWi With TWi’s help, your documentation becomes a valuable business asset. They focus on building long-term, robust relationships, so they can deliver the maximum value to customers. They are proud to serve some of the leading pharma, biopharma, and medical technology companies around the world. TWi’s relationships are built on trust and client confidentiality; therefore, they do not publicly share the names or project details of their life sciences clients, except in specific situations where they have explicit consent to do so. However, if you are looking for a reference or client feedback on TWi’s service offering, please contact them at info@technicallywriteit.com.

For more information, see www.technicallywriteit.com

Reduce Human Error and Enhance Training with documentation solutions from Technically Write IT  Reduce human error  Enhance training outcomes  Improve operational efficiency  Improve documentation quality and usability  Standardise SOPs, BMRs, and WIs  Train technical staff to write effectively  ISO 27001:2013 certified

TECHNICAL WRITING INFORMATION DESIGN TRAINING & CONSULTING TRANSLATION & LOCALIZATION

CONTACT US Ⓣ +353 (0) 21 2428800 Ⓔ info@technicallywriteit.com Ⓦ www.technicallywriteit.com

eLEARNING Irish PharmaChem | Industry Buyers Guide 2022

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Packaging Quitmann O’Neill supply packaging to the pharmaceutical, food and beverage, chemical, lubricant, coatings and waste industries. “We have evolved into a well-known and trusted packaging distribution and value-added services company,” explains David O’Neill, General Manager. “We don’t just sell packaging products; we offer process orientated valueadded services that are tailored to our customers’ needs. We are your ideal packaging management partner.”

Building your business, together

Innovative packaging, the clever way Their experienced team understand your needs, working with clients in choosing the right service level, with a range that is continuously expanding. “We believe a sound knowledge of packaging is not enough,” David reveals. “The customer’s specific service requirements are paramount in cementing a good working relationship.” Their in-house dedicated transport service ensures on time deliveries, contributing to cost effective stock control, while their central location with easy access to the motorway network allows for prompt deliveries nationwide.

and suppliers, ensuring a sustainable business, as David notes: “While we have developed our business and expanded our range, our core values have not changed: service, quality and reliability. If 2021 has taught us anything, having strong relationships, professional partners and guaranteed supply locally managed is imperative to your supply chain.”

For more information, please visit www.qonpack.com or contact their sales office: sales@quitmannoneill.com. David O’Neill, Tel: (086) 6992693, email: doneill@quitmannoneill.com Shane McEnroy, Tel: (085) 8022626, email: smcenroy@quitmannoneill.com Michelle Lucas, Tel: (090) 9741148, email: mlucas@quitmannoneill.com

Strong working relationships Quitmann O’Neill Packaging have established solid relationships with both their customers

www.qonpack.com Strengthen your supply chain by optimising your packaging management

Stockists and distributors • Barrels and drums, Steel, HDPE and Fibre • IBCs and Fibcs • Buckets, Tubs and Bottles Sales Office

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Tel 090 9741148

Email sales@quitmannoneill.com Irish PharmaChem | Industry Buyers Guide 2022


Brenntag Brenntag Pharma Pharma

Brenntag Pharma: Your partner Partner for success Success needs needs are are fulfilled fulfilled quickly quickly and and efficiently. efficiently. Customers Customerscan canconfidently confidentlyfocus focuson ontheir theircore core business, business, using using Brenntag Brenntag Pharma’s Pharma’s extensive extensive range rangeofofproducts productsand andservices, services,such suchas: as: • • Excipients coatings, emulsifiers, Excipients(binders, (binders, coatings, emulsifiers, flavours); flavours); • • Intermediates; Intermediates; • • Process Processchemicals; chemicals; • • Solvents; Solvents; • • Filling Fillingofofliquid liquidexcipients. excipients.

Supply Supplychain Chainsolutions Solutions

Brenntag BrenntagPharma Pharmaisisthe thepreferred preferreddistribution distributionpartner partnerin inthe the pharmaceutical, pharmaceutical,veterinary veterinaryand andhealthcare healthcareindustries. industries. Brenntag Brenntag Pharma Pharma offers offers aa comprehensive comprehensive range range ofof products products for for the the formulation formulation ofof pharmaceuticals pharmaceuticals and and the the chemical chemical synthesis synthesisofofActive ActivePharmaceutical PharmaceuticalIngredients Ingredients (APIs). (APIs). Their Their dedicated dedicated team team ofof chemists chemists and and pharmacists pharmacists develops develops innovative, innovative, tailor-made tailor-made solutions, solutions, be be itit oral oral dosage dosage administration, administration, e.g. e.g. tablets tablets and and capsules, capsules, or or

parenteral parenteral administration, administration, such such as as injections injections and andinfusions. infusions.

Highest Highestquality Qualityingredients Ingredients Based Based on on aa global global network network ofof suppliers, suppliers, Brenntag BrenntagPharma Pharmaprocures procuresthe thehighest highestquality quality ingredients ingredientson onthe themarket, market,while whiletheir theirglobal global logistics logisticsensure ensurethat thattheir theircustomers’ customers’business business

Their Theirextensive extensivenetwork networkofofBrenntag Brenntagsites sitesacross across the the UK UK && Ireland Ireland (including (including Brenntag Brenntag Dublin Dublin and and Brenntag Brenntag Belfast) Belfast) isis key key to to their their success success for for providing providing total total supply supply chain chain solutions solutions to to customers. customers. Their Their sites sites are are ISO ISO and and ESAD ESAD certified certified and and their their QMS QMS system/ system/ warehouse warehouse isis regularly regularly audited audited by by pharmaceutical pharmaceutical companies. companies. Brenntag Brenntag Pharma Pharma support support their their customers’ customers’ R&D R&D and and product product development development teams teams throughout throughoutprojects projectsand andvarious variousstages stagesofofnew new product product developments, developments, supplying supplying not not only only products productsbut butideas ideasand andinformation informationon onmarket market trends trendsto tocreate createaacompetitive competitiveedge edgefor fortheir their formulations. formulations.

BRENNTAG PHARMA LOCAL SERVICE NATIONAL IDENTITY GLOBAL POSITION Understanding the Importance of Safety Given the intimate relationship between pharmaceutical products and our health, it is not surprising that safety is a perennial concern for the pharmaceutical industry. Brenntag Dublin Tel: +353 (0) 1 401 3500 dublin.sales@brenntag.ie www.brenntag.ie Brenntag Belfast Tel: +44(0) 2890 787 450 belfast.sales@brenntag.co.uk www.brenntag.co.uk

ireland pharma advert| half page.indd 1 Irish PharmaChem Buyers Guide Irish PharmaChem |Industry Industry Buyers Guide2022 2020

Brenntag Pharma goes to great lengths to ensure that our entire supply chain is reliable, transparent and compliant with industry regulations.

We offer a comprehensive range of products for the formulation of pharmaceuticals and the chemical synthesis of Active Pharmaceutical Ingredients, and will support you in navigating and implementing the industry’s most stringent documentation and regulatory requirements.

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We can provide the best tailor made cooling solution to suit your requirements Utilising the most energy efficient technologies and assisting our clients to be fully compliant with the current legislative and environmental guidelines. We provide a complete solution of Mechanical Equipment, Fire Rated We can provide the best tailor made cooling SPECIALIST REFRIGERATION ENGINEERING Insulation and a wealth of application knowledge to our We can provide the best tailor made cooling solution clients.to suit your requirements solution to suit your requirements

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Utilising the most efficient technologies and solution to suit youraenergy requirements Utilising the most energy efficient technologies and vast of thewith refrigeration industry and assisting ourWith clients to beknowledge fully compliant the current assisting our clients to be fully compliant with the current sector in particular, we are the first theenvironmental Pharmaceutical Utilising the most energyand efficient technologies and legislative guidelines. We provide a legislative and environmental guidelines. We provide a choice for our large client base when it comes Passionate Packaging People Utilising the technologies andto servicing, assisting our most clients toenergy be fully compliant with the current complete solution ofefficient Mechanical Equipment, Fire Rated solution of Mechanical Equipment, Fire Rated maintaining, replacing refrigeration SPECIALIST REFRIGERATIONcomplete ENGINEERING legislative andclients environmental guidelines. We provideknowledge aall types Insulation and abe wealth ofand application to the our current SPECIALIST REFRIGERATION ENGINEERING assisting our to fully compliant with Insulation and a wealth of application knowledge to ourlarge equipment from capacity chillers to medical storage complete solution of Mechanical Equipment, Fire Rated clients. clients. SPECIALIST REFRIGERATION ENGINEERING cabinets andknowledge temperature control systems. legislative environmental guidelines. We provide a Insulationand and a wealth of application to our

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Utilising the most energy www.thepackagingcentre.com maintaining, and replacing all types clients. choice for our equipment large clientrefrigeration base it comes chillers to servicing, efficient technologies and from when large capacity to medical storage equipment maintaining, from large capacity chillersall totypes medical storage and replacing refrigeration cabinets and temperature control systems. e: sales@thepackagingcentre.ie assisting our clients to be fully cabinets and temperature control systems. With a vast knowledge the refrigeration industry and equipment from large capacity chillersof to medical storage Withcabinets a vast of the refrigeration industry and andknowledge temperature control systems. compliant with the current the Pharmaceutical sector in particular, we are the first in Technical particular, we are the first PRODUCTS & SERVICES the Pharmaceutical sectorCross legislative and environmental Solutions Ltd. choice for our large client base when it comes to servicing, • Site survey & system choice recommendation Unit 26,base Cookstown Industrial for our large client when it Estate comes to servicing, guidelines. We provide a • Supply, installation & commissioning Cookstown, Tallaght, Dublin 24 maintaining, and replacing all types refrigeration refrigeration complete solution of Mechanical Co. Dublin ‐ Ireland • Project management maintaining, and replacing all types Tel (+353) 01 405 6777 Pharmaceutical Pill/Powder Jars & medical Bottles • Energy Saving Packages equipment capacity chillers to medical equipment fromfrom largelarge capacity chillers to storage storage Equipment, Fire Rated Insulation Fax (+353) 01 4136932 • Monitoring Systems sales@crosstechnicalsolutions.ie Comprehensive Range of Food & Beverage Jars and and a wealth of application knowledge to ourPRODUCTS clients.&•SERVICES cabinets and temperature control systems. cabinets and temperature control systems. Plant service and maintenance Cross Technical Solutions Ltd.

GLASS

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Bottles

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• Monitoring Systems • Plant service and maintenance

to support your drug development programs • Biologics • Bio-analysis & Pharmacokinetic

T: +353 (0)90 646 0200 E: almacanalytical@almacgroup.com

almacgroup.com AM9348

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PAPER

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Delivering comprehensive analytical solutions

• Chemistry • Microbiology

PLASTIC


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chiral compounds Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Hovione Ltd National Chemical Company SK Pharmteco

excipients A&C Your Global GMP Partner Associated Chemicals Ltd Azelis Barentz Brenntag Ireland Camida Ltd

Irish PharmaChem | Industry Buyers Guide 2022

Chemco Ireland Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Leo Pharma Micro-Bio Ireland Ltd National Chemical Company SK Pharmteco Univar

fine chemicals A&C Your Global GMP Partner AbsorboPak Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Azelis Barentz Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd National Chemical Company SK Pharmteco Solv-Echem Ireland Ltd

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Misc. chemicals

AbsorboPak Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Azelis Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Chemifloc Ltd

Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Solv-Echem Ireland Ltd Univar

oilS, fats and waxes

Associated Chemicals Ltd Brenntag Ireland Carbon Group Corcoran Chemicals Limited Heterochem Dist Ltd

organic intermediates Arran Chemical Company Associated Chemicals Ltd Avara Shannon Pharmaceutical Services Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Hovione Ltd IDA Ireland National Chemical Company SK Pharmteco Univar

organometallics Arran Chemical Company Associated Chemicals Ltd Camida Ltd National Chemical Company

reagents Associated Chemicals Ltd Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd IDA Ireland Micro-Bio Ireland Ltd National Chemical Company Source BioScience Water Chromatography Ireland

silanes Arran Chemical Company Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Heterochem Dist Ltd Univar

solvents A&C Your Global GMP Partner Betco Marketing Ltd Brenntag Ireland Camida Ltd Carbon Group Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Soltec (Ireland) Ltd Teva Pharmaceuticals Ireland Univar Water Chromatography Ireland

surfactants A&C Your Global GMP Partner Associated Chemicals Ltd Brenntag Ireland Camida Ltd Carbon Group Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd Langanbach

TREATMENT CHEMICALS Micro-Bio Ireland Ltd

111


GENERAL SUPPLIERS ACTUATORS BS&B Safety Systems Ltd Calx Instrumentation Services Ltd

AGITATORS CPI Technology Ltd Quitmann O’Neill

AIR / ROAD / OCEAN FREIGHT AbsorboPak Hazchem Training Ltd Portakabin Ireland

AIR FILTRATION / MONITORING / INGREDIENTS A1 cbiss CMS Chemstore Engineering Ltd

AIR RESPIRATORS A1 cbiss

ALUMINIUM PRODUCTS Foltech Engineering Ltd Quitmann O’Neill

ANALYSIS SERVICES Almac Sciences Ltd ATG Scientific Ltd Bonner Charles River Microbial Solutions Corcoran Products Ltd Eurofins Biopharma Product Testing IDA Ireland Particular Sciences Ltd Reading Scientific Services Ltd

ANALYTICAL EQUIPMENT ATG Scientific Ltd Bonner Calx Instrumentation Services Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd LABPLAN Particular Sciences Ltd Scientific Instruments Ireland

ASSOCIATIONS GS1 Ireland

AUTOCLAVES Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd Scientific Instruments Ireland

AUTOMATION Bonner Calx Instrumentation Services Ltd Goliath Packaging Systems Ltd LABPLAN O’Flynn Medical Ltd Portakabin Ireland ProSys Containment and Sampling Technology Weber Packaging Solutions Ltd

BAGGING SYSTEMS Goliath Packaging Systems Ltd

112

BAG IN BOX Goliath Packaging Systems Ltd Soltec (Ireland) Ltd

BALANCES Bonner Fisher Scientific Ireland Ltd Scientific Instruments Ireland

BARCODE VERIFICATION Goliath Packaging Systems Ltd GS1 Ireland Holfeld Graphics

BARCODING / LABELLING / TRACEABILITY Corcoran Products Ltd Goliath Packaging Systems Ltd GS1 Ireland Holfeld Graphics Millmount Healthcare Weber Packaging Solutions Ltd

BIOINTERACTION ANALYSIS ATG Scientific Ltd

BIOLOGICS MSD Ireland

BIOPHARMACEUTICALS AbsorboPak A&C Your Global GMP Partner Alexion Alkermes Pharma Ireland Limited Almac Sciences Ltd Calx Instrumentation Services Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing IDA Ireland Janssen Micro-Bio Ireland Ltd MSD Ireland Pharmalex Portakabin Ireland Reading Scientific Services Ltd

BIOPHARMA/BIOTECH SUPPORTS Flexachem Manufacturing Ltd

BIOTECHNOLOGY Almac Sciences Ltd Calx Instrumentation Services Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing IDA Ireland Labplan Micro-Bio Ireland Ltd MSD Ireland Particular Sciences Ltd Pharmalex Thornshaw Scientific

BLENDERS Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd

BLISTERING / DE-BLISTERING Calx Instrumentation Services Ltd Holfeld Graphics

BLOWERS CPI Technology Ltd

BPRV BS&B Safety Systems Ltd CPI Technology Ltd

CABINETS Fisher Scientific Ireland Ltd Foltech Engineering Ltd Soltec (Ireland) Ltd Source BioScience Weber Packaging Solutions Ltd

CALIBRATION A1 cbiss Ballinlough Pharma Solutions Bonner Calx Instrumentation Services Ltd Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan LotusWorks Veolia Water Chromatography Ireland

CASE ERECTING / PACKING Goliath Packaging Systems Ltd

CASE SEALING Goliath Packaging Systems Ltd

CENTRIFUGES AQS Environmental Solutions Calx Instrumentation Services Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan

CHEMICAL CONSULTANTS Corcoran Chemicals Limited Hazchem Training Ltd

CHILLED WATER A&C Your Global GMP Partner Calx Instrumentation Services Ltd Cross Technical Solutions Daikin Europe

CHROMATOGRAPHY Charles River Microbial Solutions Fisher Scientific Ireland Ltd Labplan SK Pharmteco Water Chromatography Ireland

CLEANROOMS Calx Instrumentation Services Ltd Charles River Microbial Solutions Cross Technical Solutions Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Leo Pharma Millmount Healthcare Portakabin Ireland

CLEANING SERVICES / EQUIPMENT AQS Environmental Solutions Portakabin Ireland Irish PharmaChem | Industry Buyers Guide 2022


GENERAL SUPPLIERS CLINICAL RESEARCH ORGANISATION Charles River Microbial Solutions

COLD CHAIN PACKAGING Alexion Cold Move CRS Pharma Solutions Millmount Healthcare Quitmann O’Neill

COMPRESSED AIR / COMPRESSORS Ballinlough Pharma Solutions Calx Instrumentation Services Ltd Festo Ltd

COMPUTER SYSTEMS Charles River Microbial Solutions Chemishield Premier Validation Weber Packaging Solutions Ltd

CONDENSORS Ballinlough Pharma Solutions CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONDITION MONITORING AbsorboPak Bonner Charles River Microbial Solutions Flexachem Manufacturing Ltd Foltech Engineering Ltd LotusWorks Q1 Scientific

CONSTRUCTION MANAGEMENT Portakabin Allspace Tandem Project Management Ltd.

CONSULTANCY Accenture Hazchem Training Ltd Reading Scientific Services Ltd Tandem Project Management Ltd

CONTINUOUS PROCESSING Calx Instrumentation Services Ltd SK Pharmteco

CONTRACT DEVELOPMENT & MANUFACTURING Hovione SK Pharmteco

CONTRACT DEVELOPMENT & MARKETING Charles River Microbial Solutions Hovione SK Pharmteco

CONTRACT PHARMA SERVICES Alkermes Pharma Ireland Limited Avara Shannon Pharmaceutical Services Calx Instrumentation Services Ltd Charles River Microbial Solutions Eurofins Biopharma Product Testing Hovione McGee Pharma International Pharmalex Reading Scientific Services Ltd SK Pharmteco

CONTROLLED SUBSTANCES SK Pharmteco

CONVEYORS Goliath Packaging Systems Ltd Weber Packaging Solutions Ltd Irish PharmaChem | Industry Buyers Guide 2022

COOLING SYSTEMS Ballinlough Pharma Solutions CPI Technology Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd

DATA ACQUISITION Bonner Charles River Microbial Solutions Eurolec Instrumentation Ltd IDA Ireland Labplan Weber Packaging Solutions Ltd

DEHUMIDIFIERS Cross Technical Solutions CRS Pharma Solutions

DESIGN Ballinlough Pharma Solutions Graham Hart (Process Technology) Ltd Nelipak Healthcare Packaging Pharmalex Protech Plastics Quitmann O’Neill Tandem Project Management ltd.

DISPERSERS Fisher Scientific Ireland Ltd

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Indaver Ireland Labplan Soltec (Ireland) Ltd

DOCUMENTATION SOLUTIONS Charles River Microbial Solutions TWi

DRAINS AQS Environmental Solutions Foltech Engineering Ltd

DRIERS Calx Instrumentation Services Ltd CPI Technology Ltd

DRUMS / CONTAINERS AbsorboPak CMS Chemstore Engineering Ltd Complas Packaging Ltd Corcoran Products Ltd Industrial Packaging Ltd Interpac National Chemical Company Protech Plastics Quitmann O’Neill Soltec (Ireland) Ltd

DUST & PARTICULATE MONITORING

A1 cbiss Calx Instrumentation Services Ltd

EFFLUENT MONITORING / TREATMENT Bonner Carbon Group Veolia

ELECTRICAL Portakabin Ireland Tandem Project Management ltd.

ELECTRICAL SUPPLY Bord Gais

ENERGETIC CHEMISTRY SK Pharmteco

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Bonner Daikin Europe Leo Pharma Sustainable Energy Authority of Ireland Veolia

ENGINEERING SERVICES Berkley Group Bonner Charles River Microbial Solutions Calx Instrumentation Services Ltd Chemishield Eurolec Instrumentation Ltd Leo Pharma LotusWorks Tandem Project Management ltd.

ENVIRONMENTAL CONSULTING Charles River Microbial Solutions CMS Chemstore Engineering Ltd Quitmann O’Neill Veolia

ENVIRONMENTAL MONITORING Charles River Microbial Solutions

ENVIRONMENTAL SERVICES / EQUIPMENT AQS Environmental Solutions Bonner Charles River Microbial Solutions CMS Chemstore Engineering Ltd O’Flynn Medical Ltd Portakabin Ireland Quitmann O’Neill Soltec (Ireland) Ltd Source BioScience Veolia

EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

EXHIBITION DESIGN & DISPLAY

ECONOMIC DEVELOPMENT AGENCY

Clip Ltd Ireland

EDUCATION & TRAINING

CMS Chemstore Engineering Ltd Henley Forklift Group Limited

IDA Ireland

Calx Instrumentation Services Ltd Charles River Microbial Solutions CPI Technology Ltd Euraxess GS1 Ireland HRB Clinic Research Facility Leo Pharma Pharmalex Reading Scientific Services Ltd Science Foundation Ireland (SFI) Soltec (Ireland) Ltd Water Chromatography Ireland

EXPLOSION PROOFING

EXPLOSION PROTECTION / PANELS BS&B Safety Systems Ltd CMS Chemstore Engineering Ltd CPI Technology Ltd Henley Forklift Group Limited

EXTRUDERS BS&B Safety Systems Ltd

113


GENERAL SUPPLIERS FACILITY DESIGN ATG Scientific Ltd McGee Pharma International Pharmalex

FACILITIES MANAGEMENT AbsorboPak AQS Environmental Solutions Calx Instrumentation Services Ltd Foltech Engineering Ltd Hochtief Facility Management Leo Pharma O’Flynn Medical Ltd Quitmann O’Neill Veolia

FILLING EQUIPMENT Goliath Packaging Systems Ltd Quitmann O’Neill

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

FILTRATION Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd

FIRE DETECTION / PREVENTION / PROTECTION BS&B Safety Systems Ltd

FLAME ARRESTERS BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

FLEXCO PLATES Holfeld Graphics

FLOW CONTROL Bonner Calx Instrumentation Services Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

FLUID HANDLING CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Interpac Labplan ProSys Containment and Sampling Technology Quitmann O’Neill

FUME CUPBOARDS Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd Foltech Engineering Ltd

FURNACES Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd Scientific Instruments Ireland

GAS DETECTION A1 cbiss Bord Gais Calx Instrumentation Services Ltd CMS Chemstore Engineering Ltd Fisher Scientific Ireland Ltd

GAS SUPPLY Bord Gais Corcoran Products Ltd Scientific Instruments Ireland

114

GAUGES BS&B Safety Systems Ltd Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd

GENERATORS Scientific Instruments Ireland

GLASSWARE Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Quitmann O’Neill

GRINDING CPI Technology Ltd Fisher Scientific Ireland Ltd

HAZARDOUS WASTE DISPOSAL INGREDIENTS Chemishield Indaver Ireland Industrial Packaging Ltd Interpac Quitmann O’Neill Soltec (Ireland) Ltd Veolia

HEALTH & SAFETY / FIRST AID Charles River Microbial Solutions Hazchem Training Ltd Tandem Project Management ltd.

HEAT EXCHANGERS BS&B Safety Systems Ltd CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

HEATERS Ballinlough Pharma Solutions Calx Instrumentation Services Ltd CMS Chemstore Engineering Ltd

HOMOGENISERS CPI Technology Ltd Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

HOSES CPI Technology Ltd

HUMIDITY / HUMIDIFIERS AbsorboPak Ballinlough Pharma Solutions Bonner Calx Instrumentation Services Ltd Cross Technical Solutions Dawson Rentals Ireland Ltd Interpac Source BioScience

HYGIENIC DIAPHRAGM VALVES Flexachem Manufacturing Ltd

INCINERATION Indaver Ireland Veolia

INCUBATORS Ballinlough Pharma Solutions Calx Instrumentation Services Ltd Charles River Microbial Solutions Cross Technical Solutions Fisher Scientific Ireland Ltd ProSys Containment and Sampling Technology

INJECTION MOULDING Allstop Europe Ltd Calx Instrumentation Services Ltd Quitmann O’Neill

INSPECTION EQUIPMENT Bonner Calx Instrumentation Services Ltd Holfeld Graphics Lister Machine Tools Ltd O’Flynn Medical Ltd Weber Packaging Solutions Ltd

INSTRUMENTATION ATG Scientific Ltd Bonner BS&B Safety Systems Ltd Calx Instrumentation Services Ltd Charles River Microbial Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Labplan LotusWorks Scientific Instruments Ireland

INTERMEDIATES SK Pharmteco

IT Bonner Charles River Microbial Solutions Weber Packaging Solutions Ltd Westbourne Global IT Services

INVESTMENT Goodbody Stockbrokers IDA Ireland

INVESTMENT PROMOTION AGENCY IDA Ireland

ISOLATORS Foltech Engineering Ltd ProSys Containment and Sampling Technology

LABELLING CMS Chemstore Engineering Ltd Goliath Packaging Systems Ltd Leo Pharma

LAB IT Westbourne Global IT ServicesS

UPPLIERS LABORATORY EQUIPMENT / SUPPLIERS

ATG Scientific Ltd Bonner Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Labplan Leo Pharma Micro-Bio Ireland Ltd O’Flynn Medical Ltd Particular Sciences Ltd Portakabin Ireland ProSys Containment and Sampling Technology Scientific Instruments Ireland Solv-Echem Ireland Ltd

LABORATORY MOBILE BENCHES ATG Scientific Ltd Irish PharmaChem | Industry Buyers Guide 2022


GENERAL SUPPLIERS LABORATORY SERVICES Calx Instrumentation Services Ltd CMS Chemstore Engineering Ltd Nelipak Healthcare Packaging Reading Scientific Services Ltd Westbourne Global IT Services

LEGAL / FINANCIAL / INSURANCE Goodbody Stockbrokers

LOGISTICS AbsorboPak AQS Environmental Solutions Ballinlough Pharma Solutions C&G Logistics Group Chemco Ireland Ltd Cold Move Kuehne + Nagel Leo Pharma Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

LIFTS & HOISTS A1 cbiss Goliath Packaging Systems Ltd

LIFT TABLES Goliath Packaging Systems Ltd

LIQUID FILLING & CAPPING ATG Scientific Ltd Goliath Packaging Systems Ltd

MACHINE TOOLS Leo Pharma Lister Machine Tools Ltd Soltec (Ireland) Ltd

MAINTENANCE AQS Environmental Solutions Bonner CPI Technology Ltd Cross Technical Solutions Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Hochtief Facility Management Leo Pharma LotusWorks Particular Sciences Ltd Source BioScience Water Chromatography Ireland Weber Packaging Solutions Ltd

MANUFACTURERS A&C Your Global GMP Partner Abbvie Amneal BS&B Safety Systems Ltd Daikin Europe Endress & Hauser (Ireland) Ltd Eurolec Instrumentation Ltd Hovione IDA Ireland Leo Pharma Micro-Bio Ireland Ltd Novartis Ltd. Portakabin Ireland Ltd Quitmann O’Neill SK Pharmteco Source BioScience Thornshaw Scientific Irish PharmaChem | Industry Buyers Guide 2022

MATERIALS HANDLING / FORKLFTS / PALLET TRUCKS AbsorboPak Ballinlough Pharma Solutions Goliath Packaging Systems Ltd Henley Forklift Group Limited Interpac Leo Pharma Portakabin Ireland Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd

MECHANICAL ENGINEERING SERVICES Berkley Group Calx Instrumentation Services Ltd CPI Technology Ltd Foltech Engineering Ltd Leo Pharma LotusWorks Portakabin Ireland Tandem Project Management ltd. Veolia Weber Packaging Solutions Ltd

MECHANICAL & PROCESS ENGINEERING CPI Technology Ltd Foltech Engineering Ltd Leo Pharma LotusWorks P.J. Bonner & Company Tandem Project Management ltd. Weber Packaging Solutions Ltd

MEDICAL DEVICE MANUFACTURE Abbott B. Braun Medical Charles River Microbial Solutions LotusWorks

MEMBRANE FILTRATION SYSTEMS Microfiltration: Fisher Scientific Ireland Ltd Nanofiltration: Fisher Scientific Ireland Ltd Ultrafiltration: Fisher Scientific Ireland Ltd Reverse osmosis: Fisher Scientific Ireland Ltd

METERS Bord Gais Calx Instrumentation Services Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd

MICRO QC Charles River Microbial Solutions Leo Pharma Reading Scientific Services Ltd

MICROSCOPES Fisher Scientific Ireland Ltd Particular Sciences Ltd

MICROWAVE TECHNOLOGY Scientific Instruments Ireland

MILLING Avara Shannon Pharmaceutical Services CPI Technology Ltd Fisher Scientific Ireland Ltd

MIXERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

NOISE / ODOUR CONTROL AbsorboPak A1 cbiss Associated Chemicals Ltd ATG Scientific Ltd Flexachem Manufacturing Ltd

OEM MANUFACTURING B. Braun Medical Foltech Engineering Ltd IDA Ireland

PACKAGING / BLENDING UNDER GMP National Chemical Company

PACKAGING / DESIGN Charles Tennant & Co Ltd Complas Packaging Ltd Holfeld Graphics IDA Ireland Industrial Packaging Ltd Interpac Leo Pharma Limerick Packaging Nelipak Healthcare Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PACKAGING / MACHINERY AbsorboPak Goliath Packaging Systems Ltd IDA Ireland Interpac Leo Pharma Millmount Healthcare NPP Group Ltd Limerick Packaging Nelipak Healthcare Packaging Quitmann O’Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd

PALLETS Ballinlough Pharma Solutions Interpac Leo Pharma Quitmann O’Neill

PALLET INVERTING Goliath Packaging Systems Ltd

PARTICLE SIZING SURFACE AREA Particular Sciences Ltd Reading Scientific Services Ltd

PHARMACEUTICAL FABRICATION Charles River Microbial Solutions IDA Ireland ProSys Containment and Sampling Technology

PHARMACEUTICAL MANUFACTURE Abbvie Calx Instrumentation Services Ltd Leo Pharma LotusWorks

PIPES / CORES Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PLASTIC CONTAINERS Measom Freer Interpac Nelipak Healthcare Packaging PrimePac Ltd Protech Plastics Quitmann O’Neill Soltec (Ireland) Ltd

115


GENERAL SUPPLIERS PLASTIC CORES / TUBES Protech Plastics Quitmann O’Neill Smurfit Kappa Ireland

PNEUMATICS Flexachem Manufacturing Ltd

POLLUTION CONTROL Veolia

POWDER HANDLING AQS Environmental Solutions CPI Technology Ltd Foltech Engineering Ltd Goliath Packaging Systems Ltd Industrial Packaging Ltd Interpac ProSys Containment and Sampling Technology Quitmann O’Neill

PRESSURE MEASUREMENT / SWITCHES / VESSELS Bonner BS&B Safety Systems Ltd Calx Instrumentation Services Ltd CPI Technology Ltd Eurolec Instrumentation Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

PRESSURE RELIEF BS&B Safety Systems Ltd Calx Instrumentation Services Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

PRINT PACKAGING Contego Packaging Group Limerick Packaging Protech Plastics Quitmann O’Neill Weber Packaging Solutions Ltd

PROCESS CONTROL A1 cbiss Bonner BS&B Safety Systems Ltd Calx Instrumentation Services Ltd Charles River Microbial Solutions O’Flynn Medical Ltd Scientific Instruments Ireland

PROCESS DESIGN BS&B Safety Systems Ltd Pharmalex SK Pharmteco Tandem Project Management ltd.

PROJECT MANAGEMENT Bonner Chemishield Leo Pharma Pharmalex Reading Scientific Services Ltd Tandem Project Management Ltd

PROTECTIVE CLOTHING / APPARATUS A1 cbiss O’Flynn Medical Ltd ProSys Containment and Sampling Technology

PUMPS Calx Instrumentation Services Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd

116

Idex Pump Technologies (Ireland) Ltd Quitmann O’Neill Water Chromatography Ireland

QUALITY & COMPwwLIANCE AbsorboPak Charles River Microbial Solutions Chemifloc Ltd Leo Pharma LotusWorks McGee Pharma International Pharmalex ProSys Containment and Sampling Technology Reading Scientific Services Ltd Veolia Weber Packaging Solutions Ltd Westbourne Global IT Services

R&D Almac Sciences Ltd ATG Scientific Ltd Avara Shannon Pharmaceutical Services Charles River Microbial Solutions Chemifloc Ltd Euraxess Ireland Eurofins Biopharma Product Testing IDA Ireland Leo Pharma Pharmaceutical Manufacturing Technology Centre (PMTC) ProSys Containment and Sampling Technology Protech Plastics Reading Scientific Services Ltd SK Pharmteco Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd

RECRUITMENT Berkley Group Brightwater Chemishield ICDS Recruitment Consultants Leo Pharma Tandem Project Management ltd. Thornshaw Scientific

REFRIGERATION / FREEZING Ballinlough Pharma Solutions Calx Instrumentation Services Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawson Rentals Ireland Ltd Fisher Scientific Ireland Ltd Langanbach Services Ltd Q1 Scientific Source BioScience

RENEWABLE ENERGY Daikin Europe Sustainable Energy Authority of Ireland Veolia

RESEARCH FUNDING Pharmaceutical Manufacturing Technology Centre (PMTC) Science Foundation Ireland (SFI)

RESPIRATORY PHARMACEUTICALS Eurofins Biopharma Product Testing Reading Scientific Services Ltd Teva Pharmaceuticals Ireland Thornshaw Scientific

ROBOTICS Charles River Microbial Solutions Goliath Packaging Systems Ltd Labplan Leo Pharma

SANITARY TUBING CPI Technology Ltd Flexachem Manufacturing Ltd

SCADA /DCS / MIS Bonner ProSys Containment and Sampling Technology

SCRUBBERS Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

SEALS & GASKETS Flexachem Manufacturing Ltd

SIEVING Fisher Scientific Ireland Ltd Particular Sciences Ltd

SLEEVE / STRETCH WRAPPING Goliath Packaging Systems Ltd

SOFTWARE Ballinlough Pharma Solutions Charles River Microbial Solutions Chemishield CMS Chemstore Engineering Ltd Westbourne Global IT Services

SOLVENT RECOVERY / SERVICES Carbon Group CPI Technology Ltd Soltec (Ireland) Ltd Veolia

STABILITY STORAGE Almac Sciences Ltd ATG Scientific Ltd Ballinlough Pharma Solutions Charles River Microbial Solutions CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Eurofins Biopharma Product Testing Q1 Scientific Reading Scientific Services Ltd Source BioScience

STABILITY TESTS Particular Sciences Ltd Reading Scientific Services Ltd

STAINLESS STEEL / FITTINGS / PRODUCTS CMS Chemstore Engineering Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd Henley Forklift Group Limited Interpac ProSys Containment and Sampling Technology Quitmann O’Neill Weber Packaging Solutions Ltd

STEAM EQUIPMENT BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd

STERILITY TESTING A1 cbiss Charles River Microbial Solutions Reading Scientific Services Ltd Source BioScience Irish PharmaChem | Industry Buyers Guide 2022


GENERAL SUPPLIERS STORAGE / BUNDING Ballinlough Pharma Solutions CMS Chemstore Engineering Ltd Charles River Microbial Solutions CRS Pharma Solutions Dawsongroup | TCS Ireland Interpac Quitmann O’Neill

STORAGE OF HAZARDOUS MATERIALS C&G Logistics Group CMS Chemstore Engineering Ltd Corcoran Products Ltd CRS Pharma Solutions Dawsongroup | TCS Ireland Hazchem Training Ltd Indaver Ireland Leo Pharma Soltec (Ireland) Ltd Veolia

STRAPPING EQUIPMENT AbsorboPak

Goliath Packaging Systems Ltd

SUPPLY CHAIN MANAGEMENT AbsorboPak Alexion Ballinlough Pharma Solutions C&G Logistics Group Chemco Ireland Ltd Cold Move GS1 Ireland IDA Ireland Kuehne + Nagel KWE (Ireland) Ltd Limerick Packaging McGee Pharma International National Chemical Company Portakabin Ireland Quitmann O’Neill Solv-Echem Ireland Ltd Thornshaw Scientific

SURFACE PLASOMON RESONANCE ATG Scientific Ltd

TABLETING EQUIPMENT ATG Scientific Ltd Calx Instrumentation Services Ltd Flexachem Manufacturing Ltd

TANKS Calx Instrumentation Services Ltd Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O’Neill

TEMPERATURE CONTROL Ballinlough Pharma Solutions Bord Gais Calx Instrumentation Services Ltd CMS Chemstore Engineering Ltd Corcoran Products Ltd Cross Technical Solutions CRS Pharma Solutions Daikin Europe Dawsongroup | TCS Ireland Eurolec Instrumentation Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd KWE (Ireland) Ltd Labplan LotusWorks Bonner Q1 Scientific Source BioScience Irish PharmaChem | Industry Buyers Guide 2022

TESTING SERVICES Almac Sciences Ltd Anecto CPI Technology Ltd ATG Scientific Ltd Bonner Charles River Microbial Solutions Chemifloc Ltd CMS Chemstore Engineering Ltd Eurofins Biopharma Product Testing Reading Scientific Services Ltd

THERMAL IMAGING / THERMOGRAPHY Ballinlough Pharma Solutions Bonner Calx Instrumentation Services Ltd Eurolec Instrumentation Ltd Reading Scientific Services Ltd

TOOLS Charles River Microbial Solutions

TRAINING Hazchem Training Ltd Reading Scientific Services Ltd

TRANSPORT & LOGISTICS AbsorboPak AQS Environmental Solutions Ballinlough Pharma Solutions C&G Logistics Group Celtic Forwarding Ltd Cold Move CRS Pharma Solutions Dachser Ireland Ltd Hazchem Training Ltd Kuehne + Nagel KWE (Ireland) Ltd Leo Pharma Quitmann O’Neill Skycell AG Weber Packaging Solutions Ltd

TRAY HEAT SEALER Nelipak Healthcare Packaging

TUBE SETS / DISPOSABLES Langanbach Services Ltd Quitmann O’Neill

ULTRA SONIC MACHINES Soltec (Ireland) Ltd

VACCINES Ballinlough Pharma Solutions MSD Ireland

VACUUM SYSTEMS BS&B Safety Systems Ltd Calx Instrumentation Services Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd Particular Sciences Ltd

VALVES BS&B Safety Systems Ltd Calx Instrumentation Services Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Foltech Engineering Ltd

VALIDATION Almac Sciences Ltd Charles River Microbial Solutions Chemishield CRS Pharma Solutions Dawsongroup | TCS Ireland Eurofins Biopharma Product Testing Leo Pharma LotusWorks McGee Pharma International Pharmalex Bonner Reading Scientific Services Ltd SK Pharmteco Source BioScience Tandem Project Management ltd.

VENTILATION Cross Technical Solutions Daikin Europe

VISION SYSTEMS Particular Sciences Ltd Weber Packaging Solutions Ltd

WAREHOUSE MANAGEMENT C&G Logistics Group Celtic Forwarding Ltd CMS Chemstore Engineering Ltd Cold Move Complas Packaging Ltd Henley Forklift Group Limited Leo Pharma Portakabin Ireland Weber Packaging Solutions Ltd

WASHING EQUIPMENT Goliath Packaging Systems Ltd Leo Pharma

WASTE MANAGEMENT / BALERS / RECYCLING AQS Environmental Solutions Indaver Ireland Quitmann O’Neill Soltec (Ireland) Ltd

WATER FOR INJECTION A&C Your Global GMP Partner National Chemical Company

WATER TREATMENT Calx Instrumentation Services Ltd Charles River Microbial Solutions Chemco Ireland Ltd Chemifloc Ltd Flexachem Manufacturing Ltd Industrial Packaging Ltd InOpSys Portakabin Ireland

WEIGHING Bonner Calx Instrumentation Services Ltd Fisher Scientific Ireland Ltd Weber Packaging Solutions Ltd

WORKWEAR O’Flynn Medical Ltd

WORKWEAR MANAGEMENT DISPENSING MACHINE O’Flynn Medical Ltd

117


COMPANY LISTINGS A

ABBVIE

Address: Tel: Address:

Tel: Business:

ABBVIE Sligo – Manorhamilton Road.

071 913 6600 ABBVIE Cork - IDA Business & Technology Park, Carrigtohill, Co. Cork. (021) 488 1400 Pharmaceutical.

AbsorboPak Ltd

Address:

Tel: Email: Web: Business:

Contact:

6 Main Street, Howth, Dublin, D13P2C1, Ireland. +353 (1) 6978733 info@absorbopak.com www.absorbopak.ie With our range of desiccants, we help clients all over the world prevent moisture damage. Sé O'Leary, Sales / Technical Support

Alexion, AstraZeneca Rare Disease

Address:

College Business & Technology Park, Blanchardstown, Dublin 15, D15 R925. Tel: (01) 254 6400 ANNA julie.carney@alexion.com Email: LIVING WITH HPP Web: www.alexion.com Business: Pharmacuetical. Contact: Site Operations Coordinator: Julie Carney

Address:

Tel: Fax: Email: Web: Business:

1 Grand Canal Square, Dublin 2. (01) 646 2000

Info@accenture.com

www.accenture.com Professional Services.

Contact:

IDA Technology & Business Park, Garrycastle, Athlone, Ireland, N37X061. +353 (0)90 646 0200 +353 (0)90 646 0210 almacanalytical@almacgroup.com www.almacgroup.com Analytical services provider in GMP / GLP environments across UK, Europe and US with significant experience in the analysis of small, large and bio logic molecules. Our state of the art labs support drug substance (API), drug product (finished product) analytics across all phases of clinical development and into commercial release. Business Development: Chris Merrick

ation and our Guiding Star.

nsform the lives of people affected by rare diseases and devasAQS ENVIRONMENTAL A&Cand BY ACETO development delivery of innovative medicines, SOLUTIONSas well as Address:

Grange Business Park,

Tel: Email: Web: Contact: Business:

(061) 574 404

Skule Hill, Fedamore, es and healthcare services. alexion.com Co. Limerick

118

BioBufferSales.AC@aceto.com

www.acbiobuffer.com / www.aceto.com BioBufferSales.AC@aceto.com A&C is a global GMP manufacturer of excipients, buffers, process & cleaning solutions, and a select number of APIs. As of 2021, A&C Is part of Aceto.

CHEMICAL COMPANY LTD A Member of the Almac Group

ARRAN CHEMICAL COMPANY Address: Monksland Industrial Estate, Athlone, Co. Roscommon, N37 DN24, Ireland. Tel: +353 906 445700 Email: info@arranchemical.ie Web: www.arranchemical.ie Business: Fine chemical company specialising in the manufacture of products for Pharma, Healthcare, Flavour/ Fragrance & other specialised chemicals & industrial applications. Contact: Gareth Maguire, Business Development Manager

PANTONE GREEN 361c PANTONE BLACK CMYK GREEN: c: 78.8 m:11.5 y: 100 k:1.5 CMYK BLACK: K 100% RGB GREEN: r: 52 g: 160 b: 44 RGB BLACK: r: 35 g: 31 b: 32 HEX GREEN: #34A02C HEX BLACK: #231F20 Font: Myriad Pro

Almac Sciences Ltd.

(formerly BioClin Research Laboratories)

Accenture

Address: Tel: Email: Web: Business:

arran

Address: Castletown, Galmoy (via Thurles), Co. Kilkenny. Tel: +353 (0)504 57800 Freephone: 1800 500 020 Email: info@aqssolutions.ie Web: www.aqssolutions.ie Business: Provider of drainage, industrial cleaning, waste management and processing services. Contact: Commercial Director: Stan O’Reilly

ASSOCIATED CHEMICALS LTD Address: 16D Euro Business Park, Little Island, Co. Cork, Ireland. Tel: +353 21 4351014 Fax: +353 21 4351015 Email: info@acl.ie Web: www.acl.ie Business: Chemical Suppliers. Contact: Managing Director: Sylvester Cotter

ATG Scientific Ltd Address: Oxford Centre for Innovation, New Road, Oxford, OX1 1BY, United Kingdom. Tel: +44 (0) 1865 261423 Email: enquiries@atgscientific.co.uk Web: www.atgscientific.co.uk Business: Supply of Laboratory Products and Equipment Solutions. Contact: Andrew Graham

Irish PharmaChem | Industry Buyers Guide 2022


COMPANY LISTINGS

BonNer Azelis Ireland Limited

Instrumentation, Calibration and Control Solutions

Address:

Address:

Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Sandyford Industrial Estate, Foxrock, Dublin D18 X9X7. (01) 295 6977 (01) 295 8338 graeme.locke@azelis.ie Chemical Distributor. Managing Director: Graeme Locke

Tel: Fax: Email: Web: Business:

B

Contact:

Ballinlough Pharma Solutions Address: Tel: Email: Web: Business: Contact:

Citywest, Dublin, Annacarton Bridge, Co. Cork & Ballinlough, Co. Roscommon. Dublin 01-4600322 Cork 021-4882077 Roscommon 094-9640045 info@brltd.ie www.brltd.ie Suppliers of Thermo King Pharma Transport Refrigeration. Sales - Service - Parts Business Development: Christian Visser

Barentz Ireland Ltd Address: Block S, Grants View, Greenogue Business Park, Rathcoole, Co. Dublin. Tel: +353 1 4039518 Fax: +353 1 4039519 Email: pharmaireland@barentz.com Web: www.barentz.com Business: Distributor of excipients, amino acids and APIs to the Pharmaceutical, Nutraceutical & Biopharma industries in Ireland. Contact: Sales Manager: Storme Delaney

BERKLEY GROUP Address: Dublin: 509 The Capel Building, Mary’s Abbey, Dublin 7. Cork: Mill House, Carrigrohane, Co. Cork. International Offices: Singapore, London & Dubai. Tel: (01) 872 4666 (021) 428 9600 Email: sgreenwood@Berkley-group.com Web: www.berkley-group.com Irish PharmaChem | Industry Buyers Guide 2022

35 Western Parkway Business Centre, Ballymount Drive, Ballymount, Dublin 12. (01) 450 5050 (01) 450 5183 contact@bonner.ie www.bonner.ie Instrumentation, Calibration and Control Solutions including analysis, maintenance, temperature mapping and automation systems. Instrumentation product sales from international manufacturers. Managing Director: Patrick M Bonner Service Manager: Roddy Jefferson Control Solutions: Vernon Smit

BS&B SAFETY SYSTEMS LTD Address: Tel: Mobile: Email: Web: Business:

Contact:

B. Braun MEDICAL Address: Mobile: Fax: Email: Web: Business: Contact:

3 Naas Road Industrial Park, Dublin 12. 086 833 9836 +353 (0)1 709 1889 robert.bannon@bbraun.com www.bbraun.ie OEM manufacturing. Sales Consultant: Robert Bannon

C

CALX INSTRUMENTATION SERVICES LTD

Address:

IrIsh P Tel: Email: Web: Business: Contact:

b renntAG ireLAnd Brenntag Ireland Address: Address:

Unit Unit 405, 405, Greenogue Business Park, Business Greenogue Rathcoole, Park, Rathcoole, Dublin 24.

Tel:

+353 (0) 1 401 3500 (01) 3500 +353 (0) 1401 401 3599

Tel: Fax: Fax: Email: Web: Email: Business: Web: Contact: Contact:

Dublin 24.

(01) 405 3501 dublin.sales@brenntag.ie www.brenntag.ie dublin.sales@brenntag.ie Chemical Suppliers & www.brenntag.ie Distributors. Sales Desk Evelyn O'Connor: evelyn.o'connor@brenntag.ie Cole Carroll: colman.carroll@brenntag.ie

briGhtwAter Address: Tel: Fax:

36 Merrion Square, Dublin 2. (01) 662 1000 (01) 662 3900

Raheen Business Park, Raheen, Co. Limerick, V94 N4V2. (061) 484 700 (086) 8385556 sales@bsb.ie www.bsbflamearrester.ie www.bsb.ie - Rupture Disks, Safety Heads, Sensors, Graphite Disks and accessories; - Custom Engineered Product solutions for the OEM; - Explosion Vents, Suppression/ Isolation units; - Specialty Buckling Pin Relief Valves; - Flame Arresters, Breather Valves and PVRV's/Emergency Vents; - Process Systems for the Oil & Gas, Chemical & Refining industries. Manager: Patrick Murphy Ireland Direct Sales Manager

Unit 34A, Kells Business Park, Cavan Road, Kells, Co. Meath, A82 X4H5. hem harma

C

0818 250 250

2012

info@calx.ie www.calx.ie Calibration service. Building 1000, Operations Director/Owner: Units 1201& 1202, Kevin Davis

City Gate, Mahon, Cork. Tel: (021) 240 9099 Fax: (021) 240 9009 Email: mail@calleng.ie Web: www.calleng.ie Business: Multi-discipline CAMIDA LTDconsulting engineering and project managment Address: New Quay, Clonmel, Co.company. Tipperary, E91 YV66, Tel: c AmidA Fax: Email: Address: Web: Contact:

Tel: Fax: Email: Web: Contact:

Ireland. +353 52 6125455 Ltd +353 52 6125466 info@camida.com Tower House, www.camida.com New Quay, Company Secretary: Clonmel, Deirdre McGrath

Co. Tipperary. (052) 612 5455 (052) 612 5466 info@camida.com 119 www.camida.com Company Secretary: Deirdre McGrath

Contact:

ceLtic f Address:

Tel: Fax: Email: Web: Business: Contact:


COMPANY LISTINGS

Charles Tennant & co Ltd Address:

carbon group Address: Tel: Mobile: Fax: Email: Web: Business: Contact:

Ringaskiddy, Co. Cork, P43 R772. +353 (0)21 437 8988 +353 (0) 86 2612 485 +353 (0)21 437 8950 carol.deegan@carbon.ie sales@carbon.ie www.carbon.ie Pharma/biopharma chemicals. Area Sales Manager: Carol Deegan

Tel: Fax: Email: Web: Business:

71 Cookstown Ind Estate, Belgard Road, Tallaght, Dublin 24. (01) 451 4099 (01) 451 4702 jgrehan@ctennant.ie www.charlestennant.com Chemical and Packaging supplier.

Address:

Address:

Tel: Email: Web: Business:

Contact:

Block 20A, Beckett Way, Park, West Business Park, Dublin 12, D12 P8R2 +353 (0)1 8429300 sales@certificationeurope.com www.certificationeurope.com ISO Management Standards Certification body for ISO 9001, 14001, 45001, 50001, 27001, 22301 and 20000-1 Rob Lyons, Sales and Marketing Manager

Charles River Laboratories Ireland Ltd Address:

Email: Web: Business:

Carrentrila, Ballina, Co. Mayo, F26 D786, Ireland. askcharlesriver@crl.com criver.com/biologics Biologics Testing Solutions.

Tel: Fax: Email: Web:

Email: Web: Business:

120

49, Greenogue Business Park, Jordanstown Ave, Jordanstown, Rathcoole, Co. Dublin, D24 NF21, Ireland. askcharlesriver@crl.com criver.com/microbial Micro QC.

Clondrinagh Industrial Estate, Ennis Road, Limerick, V94 XT27. (061) 327792 hello@chemstore.ie www.chemstore.ie Solutions provider for the safe storage and management of Hazardous Materials.

Unit 2, Stadium Business Park, Ballycoolin, Cappagh, Dublin 11, D11 X205. +353 (0)1 8293600 +353 (0)1 8855029 info@chemco.ie www.chemco.ie

Address: Tel: Fax: Email: Web:

Naas Industrial Estate, Dublin Road, Naas, Co. Kildare. (045) 874 088/9 (045) 874 090 sales@complas.ie www.complas.ie

CORCORAN CHEMICALS LTD

Contact:

17 Parkgate Street, D08 NRP2. (01) 633 0400 (01) 679 3521 info@corcoran-group.com www.corcoran-group.com Distributors of raw materials for the food, pharmaceutical, polymer & chemical industry. Sales

Chemifloc Group: Chemifloc, GI Chemicals, Chemilabs Address: Tel: Fax: Email: Web: Business:

Contact:

Address:

Tel: Email: Web: Business:

Address: Tel: Fax: Email: Web: Business:

Charles River Microbial Solutions International Ltd

Address:

complas packaging ltd Chemco Ireland Limited

CERTIFICATION EUROPE Limited

CMS Chemstore Engineering Ltd.

Smithstown Ind Est, Shannon, Foynes Port, Limerick. 061 708699; 021 4911643 (GI) +353 61 708653 info@gichemicals.ie; info@chemilabws.ie chemifloc.ie; gichemicals.ie Chemifloc: Water Treatment Chemicals; GI: Industrial Chemicals, Chemilabs: Laboratory Technical Services Fergal Lawless, Tom Kelly (GI) Director, GM (GI)

Chemishield Address: Tel: Email: Web: Business: Contact:

Arc Labs, Carriganore, Waterford. +353 (0)51 576 025 info@chemishield.com www.chemishield.com Software & Life Sciences Consultancy. Commerical Director: James Steele

CORCORAN PRODUCTS (IRL) LTD Address: Tel: Email: Web: Business:

Contact:

Unit 12, Northern Cross Business Park, Finglas, D11 DC67. (01) 864 4422 info@corcoran-group.com www.corcoran-group.com Suppliers of packaging to the food, pharmaceutical and chemical industry. Derek Lennon

CPI technology ltd

Address:

Tel: Fax: Email: Web: Business: Contact:

Unit 5 Link Road, Business Park, Ballincollig, Co. Cork. (021) 487 4142 (021) 487 8764 info@cpitechnology.com www.cpitechnology.com Providers of Process Equipment. Managing Director: Adrian Giltinan

Irish PharmaChem | Industry Buyers Guide 2022


COMPANY LISTINGS D

E

CROSS TECHNICAL SOLUTIONS Address: Tel: Fax: Email: Web: Business: Contact:

9/10 Broomhill Road, Tallaght, Dublin 24. (01) 405 6777 (01) 413 6932 jmcgrath@crosstechnicalsolutions.ie www.crosstechnicalsolutions.ie Refrigeration. Technical Director: Jonathan McGrath General Manager: Jason Keating

ENDRESS+HAUSER (IRELAND) LTD. Dachser Ireland Ltd

Address:

Tel: Email: Web: Business:

CRS Pharma Solutions

Address:

Tel: LoCall: Email: Web: Business:

Contact:

Dublin, Belfast, London, Manchester. +353 46 943 5000 1890 929 824 info@crspharmasolutions.ie www.crspharmasolutions.ie GxP compliant pharmaceutical portable temperature controlled storage solutions, chamber temperatures range from -65°C to +60°C. Close control temperature and humidity stores, stability chambers, incubators, Atex cold stores, dual redundant cooling systems with integral back-up generators, blast freezers, freezers for fast freezing of phase change materials (Eutectic plates and gel packs). Technical Business Development Manager: Pat O’Connor

Blackchurch Business Park, Rathcoole, Co. Dublin, D24 C796. +353 1 401 3333 dachser.ireland@dachser.com www.dachser.ie With our comprehensive European road transport network of system and charter service, as well as a homogeneous structure of branches, subsidiaries and partner companies, we will support you in fulfilling your logistics requirements reliably, cost-effectively and on time. We transport your groupage, your full or partial loads and manage your procurement and distribution, both Europe-wide and national, to the highest level.

Address:

Tel: Email: Web: Business:

Contact:

Exchequer House, Embassy Office Park, Kill, Co. Kildare. (045) 989 200 info.ie.sc@endress.com www.ie.endress.com Leading supplier of products, services and solutions for industrial process measurement and automation industry. Sales Manager: Brian O’Connell

Eurofins BioPharma Product Testing Address:

Tel: Email: Web:

Clogherane, Dungarvan, Co. Waterford, X35 T628, Ireland. +353 (0) 58 48300 EurofinsBPT-IE@eurofins.ie www.eurofins.ie/biopharma-services

Dawson GROUP | TCS Ireland Address:

Tel: Email: Web: Business: Contact:

Unit JB, Beech Avenue, Naas Enterprise Park, Newhall, Naas, Co. Kildare. 045 448810 susanconroy@dawsongroup.ie www.dawsongroup.ie Temperature Controlled Solutions. Managing Director: Susan Conroy

eurolec instrumentation ltd Address: Tel: Fax: Email: Web: Business:

Technology House, Cluan Enda, Dundalk, Co. Louth. (042) 933 3423 (042) 933 1758 info@eurolec-Instruments.com www.eurolec-instruments.com Electronic instrumentation.

F

festo ltd Address: Tel: Fax: Email: Web: Business:

Irish PharmaChem | Industry Buyers Guide 2022

Unit 5, Sandyford Park, Sandyford Industrial Estate, Dublin 18. (01) 295 4955 (01) 295 5680 sales_ie@festo.com/ie www.festo.com/ie Automation company specialising in factory and process automation.

121


IrIsh PharmaChem 2011 H hAzcheM trAininG Ltd Address:

G10, Maynooth Business Campus, GoLiAth pAckAGinG FISHER SCIENTIFIC f isher scientific Maynooth, s ysteMs Ltd IRELAND LTD GS1 Ireland Co. Kildare. Address: Suite 4, Plaza 212, Address: Second Floor, Beechwood, Address: The MerrionNenagh, Address: Suite 6, Plaza 212, Tel: (01) 629 1800 Blanchardstown Co. Tipperary. Blanchardstown, Centre, Nutley Lane, HETEROCHEM DIST LTD Corporate Park, Ballycoolin, Fax: Corporate Park 2, Tel: (067) 37893 Donnybrook, Dublin 4. Address: Unit 49,(01) 629 1822 Dublin 15, D15 VY66. Tel:Fax: (01) 208 0660 Ballycoolin, (067) 34794 Email: info@hazchem.ie Robertson House, Tel: (01) 885 5854 Fax: (01) 208 0670 Baldoyle Industrial Est., Dublin 15. Email: info@goliath.ie Web: www.hazchem.ie Fax: (01) 899 1855 13. Email: healthcare@gs1ie.org Email: fsie.sales@thermofisher.com Contact: Dublin Director: Tel: (01) 885 5854 Web: www.goliath.ie Tel: (01) 839 3127 Web: www.gs1ie.org/healthcare Web: www.ie.fishersci.com Michelle Cleere Fax: (01) 899 1855 Business: Supply & Email: info@heterochem.com Business: Global Supply Chain Business: Laboratory supplies, Web: www.heterochem.com Email: fsie.sales@thermofisher.com of Chemicals, Consumables, Standardsinstallation Body. Distributors Reagents, Equipment & Web: www.ie.fishersci.com packaging equipment Business: henLey fChemical orkLift & Raw Material Specialists. Instruments. Business: Laboratory and materials Group Ltd Contact: Managing Director: Contact: Portfolio Manager: supplies. handling systems. Address: Henley Industrial Kim Doran Gerry Fitzmaurice Contact: Marketing Contact: Director: Park, Killeen Road, kim@heterochem.com H Manager: George O’Leary Dublin 10. Gerry Fitzmaurice Tel: (01) 620 9200 GouLdinG cheMicALs Ltd Fax: (01) 626 5406 fLexAcheM Address: Centre Park Road, Email: fwilson@henley.ie Holfeld Graphics MAnufActurinG Ltd Marina, Cork City. Address: phammett@henley.ie Unit 3, Jamestown flexachem Donnybrook hazchem training ltd Tel: (021) 491 1611 Web: Industrial Estate, www.henley.ie Address: Kylemore Way, manufacturing ltd Centre, Address: G10, Maynooth Business Dublin, D08 PF1C. Business: Forklifts & Fax: (021) 491 1660 Commercial Address: Donnybrook Commercial Campus, Maynooth, Tel: (01) 285 5233 Warehousing Email: pollockm@gouldings.ie Douglas, Co. Cork. Centre, Douglas, Cork, T12 X68Y. Co. Kildare. Email: rory@holfeldgraphics.com Tel: (021) (021) 461 7200 Equipment. Tel: 461 7200 Tel:Web: (01) 629www.gouldings.ie 1800 Web: www.holfeldgraphics.com Email: sales@flexachem.com Specialists in Business: (01) 629Chemical Fax: (021) 489 1297 Fax: 1822 Business: Manufacturer of Flexo plates Web: www.flexachem.com flameproof distributor. Email: sales@flexachem.com Business: Mechanical Process Equipment Email: info@hazchem.ie for Hapa Blister printers, forklift trucks. Valves, Supplier Pumps, Seals, Agents for Axicon, ISO Barcode www.hazchem.ie Web: www.flexachem.com Web: Process Equipment, Biotech and Contact:Verifiers (GS1Director: 128, GS1 Business: Training and Consultancy G rAhAM h Art Business: Pharma Manufacturer/ Equipment and Technical Datamatrix, etc.,) Mark Kenny Services. (process technoLoGy) Ltd Distributor. Support. Contact: Manager: Michelle Cleere Director: Contact: Commercial Manager: Director: Address: Friars Ind. Estate, Contact: Commercial Michael Bradley Brian O’Connell Bradford Road, Agnes Mullins Idle, Bradford, HENLEY FORKLIFT BD10 8SW, UK. hochtief fAciLity GROUP LIMITED g Tel: (0044) Park, 1274 617021 MAnAGeMent Address: Henley Industrial Killeen Road, Dublin 10. 618614 Fax: (0044) 1274 Address: Ireland: Tel:Email: (01) 620 9200 Hovione Ltd HOCHTIEF Facility sales@graham-hart.com Fax: (01) 626 5406 Address: Loughbeg,Management Ringaskiddy, Web: www.graham-hart.com Foltech Engineering Ltd Email: pharma@henley.ie Co. Cork, Ireland. Address: The Store House, Charleston Contact: Sales Director: Ireland Ltd., Web: www.henley.ie/pharma Tel: +353 21 451 2856 Maltings, Midleton, Co. Cork. Stephen Hart Landscape House, G LAnbiA estAtes Business: Forklift and warehousing Fax: +353 21 437 8697 Tel: (021) 463 9592 Landscape Road, Address: Glanbia House, Email: info@foltech.ie equipment, sales, service, Email: hello@hovione.com Web: www.foltech.ie Churchtown, Ring Road, Web: www.hovione.com hire, parts, driver training, Business: Mechanical Engineering. Contact: General Manager: thorough examinations. Dublin 14. Co. Kilkenny. Contact: Director: John Foley Dr. Paul Downing Director: UK: Tel: +353 (0) 87 256 4339 Contact: Brian O’Connell HOCHTIEF Facility Email: gmullally@glanbia.com boconnell@henley.ie Management UK Ltd, Web: www.kilmeadenfields.com G Gs1 ireLAnd HOCHTIEF House, Business: Property Business Address: The Nutley Building, 2 Ibis Court, Unit of Glanbia PLC. Graham Hart (Process Merrion Road, Centre Park, Contact: CEO: Ger Mullally Technology) Ltd Dublin 4. WarringtonWA1 1RL Address: Friars Industrial Estate, Bradford Road, Idle, Bradford, Tel: (01) 208 0660 Tel: (01) 215 7000 BD10 8SW, UK. Fax: (01) 208 0670 +44 1925 404 500 Tel: (0044) 1274 617021 Email: info@gs1ie.org Fax: (01) 215 7070 Fax: (0044) 1274 618614 Web: www.gs1ie.org Email: sales@graham-hart.com +44 1925 404 598 Web: www.graham-hart.com Contact: Member Support Services: Email: Karen Murphy Web: www.hochtief-fm.ie Irish PharmaChem | Industry Buyers Guide 2022 122 57

53_63 Company Listings 2011.indd 5

ComPany LIstIngs

COMPANY LISTINGS

05/07/2011 12:15


COMPANY LISTINGS I

L

ICDS Recruitment Consultants

Address:

Address:

Tel: Email: Web: Business:

Connacht House, 24 Upper Fitzwilliam Street, Dublin 2. +353 1 632 1200 info@icds.ie www.icds.ie Specialist Recruitment Consultants to the Pharmaceutical, Life Science, Chemical, Medical Device, Food and Technology sectors.

IDA IRELAND Address:

Three Park Place, Hatch Street Upper, Dublin 2. Tel: (01) 603 4000 Email: idaireland@ida.ie Web: www.idaireland.com Business: Investment Promotion & Development Agency.

LABPLAN

interpac Address:

67E Heather Road, Sandyford Industrial Estate, Sandyford, Dublin 18, D18 NV90. Tel: (01) 294 0600 Fax: (01) 294 0602 Email: ian@interpac.ie Web: www.interpac.ie Business: Supplier of packaging to the pharmaceutical, hazardous waste, food and dairy industries. Contact: Director: Ian Sutton

invest northern ireland Address: Tel: Fax: Email: Web: Business:

idex pump technologies (ireland) ltd Address: Tel: Email: Web:

Bay 145, Shannon Industrial Estate, Shannon, Co. Clare, V14 XE40. (061) 471933 vsicsipti@idexcorp.com www.blagdonpump.com www.vikingpump.com

Address:

The Highline, 1st Floor, Bakers Point, Pottery Road, Dun Laoghaire, Co. Dublin, A96 KW29. Tel: (01) 697 2900 Fax: (01) 633 5464 Email: info@indaver.ie Web: www.indaver.ie Business: Hazardous & nonhazardous waste disposal and recovery ensuring full compliance.

Contact:

Address: Tel: Email: Web: Contact:

Address:

Kuehne + Nagel IRELAND

Tel: Email: Web: Business:

lennox laboratory supplies ltd

Unit D2 Horizon Logistics Park, Harristown, Swords, Co. Dublin, K67 Y954. (01) 823 9777 Seamus.keane@kuehne-nagel.com ie.kuehne-nagel.com Global Freight Forwarding & Supply Chain Management. Seamus Keane, National Key Account Manager (Pharma & Healthcare) Mob: +353 85 8666646

Tel: Email: Web: Business: Contact:

Address: Tel: Fax: Email: Web: Business:

GDP Wholesale Licence Holder

INOPSYS NV Tel: Email: Web: Business: Contact:

Zandvoortstraat 12A, 2800 Mechelen, Belgium. +32495653821 thomas.windels@inopsys.eu www.inopsys.eu Providing circular side stream solutions. Purifying water and recovering materials with mobile & modular installations. Sales Manager: Thomas Windels

Irish PharmaChem | Industry Buyers Guide 2022

Dublin Head Office & Temperature Controlled Warehouse Facility Address: Horizon Logistics Park, Harristown, Swords, Co. Dublin. Tel: (01) 823 9600 Fax: (01) 836 1111 Email: kwedub@kwe.com dubsls@kwe.com Web: www.kwe.com Cork Regional Office & Warehouse Facility Address: South Ring West Business Park, Tramore Road, Cork. Tel: (021) 497 5722 Fax: (021) 497 5727 Email: kweork@kwe.com

Eastlink Business Park, Ballysimon Rd., Limerick. (061) 400 035 info@lmkpkg.ie www.limerickpackaging.ie Packaging manufacturers, Distributors, Designers and Auditors. Sales Director: Mike Boland

LISTER MACHINE TOOLS LTD

KWE (Ireland) Ltd

Address:

John F. Kennedy Drive, Naas Road, Dublin, D12FP79. (01) 460 7600 padraig.callan@lennox.ie www.lennox.ie Padraig Callan, Head of Business Development

LIMERICK PACKAGING

K

Address:

INDAVER IRELAND

Bedford Square, Bedford Street, Belfast, BT2 7ES. (048) 9069 8601 (048) 9043 6536 patricia.oneill@investni.com www.investni.com Economic development agency.

Tel: Fax: Email: Web: Business:

Allenwood Enterprise Park, Allenwood, Naas, Co Kildare. (045) 870 560 (045) 870 811 info@labplan.ie www.labplan.ie Lab supplier of analytical instrumentation, services, technical support.

PO Box 838, Bluebell Industrial Estate, Dublin 12. (01) 450 8866 (01) 450 9836 sales@listermachinetools.com www.listermachinetools.com Sales and service of Machine Tools and related accessories, consumables and metrology equipment.

LotusWorks

Address:

Tel: Email: Web: Business:

Building 3, Finisklin Business Park, Sligo, F91 KAP2. (071) 916 9783 contactus@lotusworks.com www.lotusworks.com Engineering & Technical Solutions Provider.

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COMPANY LISTINGS

M

N

maclachlan & donaldson Address: Tel: Fax: Email: Web: Business: Contact:

47 Merrion Square, Dublin 2. (01) 676 3465 (01) 661 2083 mail@maclachlan.ie www.maclachlan.ie Intellectual Property Attorneys. Dr. Yvonne McKeown

o’flynn medical ltd

Address:

NATIONAL CHEMICAL COMPANY Address: Tel: Fax: Email: Web: Business:

Micro-Bio Ireland Ltd

Address:

Tel: Fax: Email: Web: Business: Contact:

Industrial Estate, Fermoy, Co. Cork (025) 31388 (025) 32458 info@micro-bio.ie www.micro-bio.ie Chemical Manufacturer. Sales Director: Tom Tobin

Contact:

Tel: Email: Web: Business:

Contact:

124

Red Oak North, South County Business Park, Leopardstown, Dublin 18. +353 (0)1 299 8700 info@msd.ie www.msd.ie MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ approximately 2,700 employees, across six sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow, Dunboyne and Dublin and, in addition, operate substantial Human Health and Animal Health businesses. Our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world. Mairead McCaul MSD Ireland (Human Health) LTD

P The Packaging Centre Ltd For all your packaging needs

TPC

Fox & Geese House, Naas Road, Dublin 22. Tel: 01 450 8759 ~ Fax: 01 450 7567 www.thepackagingcentre.ie

Pantone 2935

The Packaging Centre Ltd

Nelipak Healthcare Packaging Tel: Email: Web: Business:

MSD Ireland

Contact:

Address:

Address:

Address:

NCC House, 42 Lower Leeson St., Dublin 2, D02 FX39. (01) 613 1400 (01) 634 0132 sales@ncc.ie www.ncc.ie Supply Chain PartnerLife Sciences Industry. Product Manager: Christy Smith

Tel: Email: Web: Business:

Macroom Environmental Park, Bowl Road, Macroom Co. Cork, P12 YD92. (029) 21 799 info@oflynnmedical.com www.oflynnmedical.com Distributor of OSL “Automated Protective Clothing Distributor”. Conor O’Flynn

Contact:

Unit 6D, Mervue Business Park, Mervue, Galway. (091) 757 152 info@nelipak.com www.nelipak.com Innovative packaging solutions and complementary products and services for the healthcare market serving the medical and pharmaceutical sectors. Director of Global Marketing: Sean Egan

npp group ltd Address:

Tel: Email: Web: Business:

Unit 509, Mitchelstown Road, Northwest Business Park, Ballycoolin, Blanchardstown, Dublin 15. (01) 880 9299 sales@npp.ie bmcmahon@npp.ie www.npp.ie Flexible packaging suppliers & distributors.

Tel: Fax: Email:The Web: Contact:

TPC

Fox & Geese House, Naas Road, Dublin 22. (01) 450 8759 (01) 450 7567 sales@thepackagingcentre.ie Packaging Centre Ltd Forwww.thepackagingcentre.ie all your packaging needs Director: Ivan Fox &Managing Geese House, Naas Road, Dublin 22. Powell Tel: 01 450 8759 ~ Fax: 01 450 7567 www.thepackagingcentre.ie

particular sciences ltd

Address:

Tel: Fax: Email: Web: Business: Contact:

2 Birch House, Rosemount Business Park, Ballycoolin Road, Finglas, Dublin D11 T327. (01) 820 5395 (01) 822 8813 info@particular.ie www.particular.ie Supply and Service Laboratory Equipment. Managing Director: Sean Quilty

O

OCON CHEMICALS LTD Address:

Tel: Fax: Email: Web:

Unit 5, South Cork Industrial Estate, Vicars Road, Pouladuff, Co. Cork. (021) 431 8555 (021) 431 8560 info@oconchemicals.com www.oconchemicals.ie

Pharmaceutical Manufacturing Technology Centre (PMTC)

Address:

Tel: Email: Web: Business: Contact:

Bernal Institute, University of Limerick, Co. Limerick, V94 T9PX. 086 8530310 pmtc@ul.ie pmtc.ie Research and development. Centre Director: Sarah Hayes

Irish PharmaChem | Industry Buyers Guide 2022

CMYK Cyan: 100 Magenta: 50


COMPANY LISTINGS

R

Pharmalex Address: Tel: Email: Web: Business:

Contact:

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525. +353 1 846 4742 Victor.cowper@pharmalex.com www.pharmalex.com/ireland An award winning EU and US Quality, Technical & Compliance consultancy to the life science industry. Client Services Manager: Victor Cowper

pilz ireland

Address:

Tel: Fax: Email: Web: Business:

Cork Business & Technology Park, Model Farm Road, Co. Cork. (021) 434 6535 (021) 480 4994 sales@pilz.ie www.pilz.ie Process and machinery safety engineering services and training.

ProSys Containment And Sampling Technology Address: IDA Business Park, Carrigtohill, Co. Cork, Ireland, T45AP82. Tel: +353 21 4853900 Fax: +353 21 4853866 Email: Michael.Hennessy@prosysgroup.com Web: www.prosysgroup.com Contact: Head of Global Sales: Michael Hennessy

Q

Tel: Email: Web: Business:

Contact:

Roseville Business Park, Turvey Avenue, Donabate, Co. Dublin. (01) 808 5055 karen.brennan@portabin.com www.portakabin.ie Portakabin is the pioneer of modular construction in Europe, delivering interim and permanent bespoke buildings, of any size and to fulfil almost any application, site and design. Portakabin has provided award-winning off-site built environments of outstanding quality, with unrivalled on time and on budget performance, for over 50 years. Marketing Executive: Karen Brennan

Tel: Email: Web: Business: Contact:

The Reading Science Centre, Whiteknights Campus, Pepper Lane, Reading, Berkshire, RG6 6LA, UK. +44 (0) 118 918 4076 enquiries@rssl.com www.rssl.com Analytical Testing Laboratory. Commercial Lead Biopharma & Personalised Medicine: Gaynor Johnston

Science foundation ireland (SFI) Address:

Address:

Address:

S

Q1 SCIENTIFIC

Portakabin Ireland

Reading Scientific Services Limited

87 Westside Business Park, Co. Waterford. Tel: (051) 355977 Email: info@q1scientific.com Web: www.q1scientific.com Business: Stability Storage (ICH/GMP). Contact: Louise Grubb, CEO

Quitmann O’Neill Packaging Ltd Address: Tel: Fax: Email: Web: Business: Contact:

St. Brendan’s Road, Portumna, Co. Galway, H53 HX51. (090) 9741148 (090) 9741459 sales@quitmannoneill.com www.qonpack.com Packaging Disributor and Stockist. David O’Neill

Address: Tel: Fax: Email: Web: Business: Contact:

Wilton Park House, Wilton Place, Dublin 2. (01) 607 3200 (01) 607 3201 info@sfi.ie www.sfi.ie Government funding agency for research. Director - Strategy and Communications: Dr. Ruth Freeman

Scientific Instruments Ireland

Address:

Tel: Email: Web: Business:

Contact:

Oulart House, Cullagheerva, Clonsilla, Dublin 15. 087 9813310 info@siireland.ie www.siireland.ie Distribution and Service Support of Sample Preparation and Analytical Equipment. Sales Director: Aaron Ryder

PPD, Inc. Address:

Tel: Fax: Email: Web: Business:

Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath. (0906) 460 300 (0906) 460 301 susan.neenan@ppdi.com www.ppdi.com Contract Research Organisation.

Irish PharmaChem | Industry Buyers Guide 2022

125


COMPANY LISTINGS

T

SK pharmteco Address: Tel: Email: Web: Business: Contact:

Watery Lane, Swords, Co. Dublin. (01) 813 9000 skpharmteco@sk.com www.skpharmteco.com Contract Development Manufacturing Organisation. Brian Fairley, Director Business Development & Marketing

SkyCell AG Address: Tel: Email: Web: Business: Contact:

Gotthardstrasse 28, 6300 Zug, Switzerland. 044 533 23 00 info@skycell.ch skycell.ch Pharmaceutical Logistics & Supply Chain Solutions. Sales Department: sales@skycell.ch

SMURFIT KAPPA IRELAND Address:

Tel: Fax: Email: Web: Business:

Ballymount Road, Walkinstown, Dublin 12. (01) 409 0000 (01) 456 4506 info@smurfitkappa.ie www.smurfitkappa.ie www.skpackaging.ie Packaging.

SOLTEC (IRELAND) LTD Address:

Tel: Fax: Email: Web: Business:

Zone A, Mullingar Business Park, Mullingar, Co. Westmeath. (044) 933 5133 (044) 934 5248 info@soltec.ie www.soltec.ie Waste management.

Source BioScience

Address: Tel: Email: Web:

Riverstown 5 Complex, Tramore, Republic of Ireland. +353 (0) 51 338435 salesireland@sourcebioscience.com www.sourcebioscience.com

Tandem Project Management Ltd. Address:

Tel: Email: Web: Business:

SSPC, SFI RESEARCH CENTRE FOR PHARMACEUTICALS Address:

Web: Business: Contact:

Bernal Institute, University of Limerick, Limerick, Ireland. www.sspc.ie Pharma Research Centre. Executive Director, Dr. Margaret Lawlor

Contact:

11 Nessan House, Mahon Industrial Estate, Blackrock, Cork, T12 XN4V. (021) 2038130 info@tandempm.ie www.tandempm.ie Tandem is an expert project management and engineering design consultancy successfully delivering to life science clients in Ireland, the UK and Europe. Tandem’s results orientated services include project management, project controls, multi-disciplined engineering design, construction management, energy & carbon reduction and CQV. Tandem also provide client representative teams, operational readiness consultancy and talent solutions. Customer Relations Manager: Linda Nugent 0876897995 linda.nugent@tandempm.ie

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Tel: Email: Web: Business:

Glasnevin, Dublin 9. (01) 836 9080 info@sei.ie www.sei.ie Energy advice & information.

Toyota Material Handling Ireland Ltd Address: Tel: Web: Business: Contact:

Killeen Road, Dublin 12. (01) 419 0200 www.toyota-forklifts.ie Forklift and Warehouse Supplies. Noel Foley

TWi Address:

SOLV-ECHEM IRELAND LTD Address:

Tel: Email: Web: Business:

126

Great Island Industrial Park, Ballincollig, Co. Cork. (021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing.

West Building, Carrigaline Industrial Park, Carrigaline, Cork, Ireland. Tel: +353 (0)21 242 8800 Email: info@technicallywriteit.com Web: www.technicallywriteit.com Business: Technical writing, information design, and documentation solutions service provider. Contact: Emmet Kearney, Business Development Manager Irish PharmaChem | Industry Buyers Guide 2022


COMPANY LISTINGS

U

Univar SOLUTIONS Address:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin. Tel: (01) 401 9800 Email: irelandsalesoffice@univarsolutions.com Business: Chemical Distribution Contact: Key Account Manager: Carla Byrne

Westbourne IT Global SERVICES Address:

Blackpool Retail Park, Blackpool, Co. Cork. Tel: (021) 431 4310 Email: james.symington@westbourneit.com Business: IT Service Provider. Contact: James Symington, Business Development

W

wRENTECH LTD

Weber Packaging Solutions Ltd

Address:

Tel: Fax: Email: Web:

Tel: Fax: Email: Web:

Address:

Kilcannon Industrial Estate, Old Dublin Road, Enniscorthy, Co. Wexford. (053) 923 3778 (053) 923 3284 sales@weberireland.com www.webermarking.ie

Eversley, Church Bay Road, Crosshaven, Co. Cork. (021) 483 2644 (021) 483 1363 smurray@wrentech.ie www.wrentech.ie

NOTES

Irish PharmaChem | Industry Buyers Guide 2022

127


USEFUL REFERENCES

ACADEMY OF CLINICAL

ELECTRICITY SUPPLY

INSTITUTE OF CHEMISTRY

IRISH PHARMACY UNION

SCIENCE AND LABORATORY

BOARD

OF IRELAND

Tel: (01) 493 6401

MEDICINE

Tel: 1850 372 757

E-mail: info@instituteofchemistry.org

E-mail: info@ipu.ie

Tel: (01) 905 9730

E-mail: esbnetworks@esb.ie

Web: chemistryireland.org

Web: www.ipu.ie

E-mail: mail@acslm.ie

Web: www.esb.ie Intellectual Property Office

IRISH VENTURE CAPITAL

ENTERPRISE

of Ireland

ASSOCIATION

IRELAND

Tel: (056) 772 0111 E-mail: ipinfo@ipoi.gov.ie Web: https://www.ipoi.gov.ie/en/

Tel: (01) 276 4647

MANDATE TRADE UNION

Web: www.ehai.ie

INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINERING (ISPE) Tel: +1 (813) 960 2105 E-mail: ask@ispe.org Web: www.ispe.org

ENVIRONMENTAL

INVEST NORTHERN IRELAND

Web: www.acslm.ie AN BORD PLEANALA Tel: (01) 858 8100 LoCall: 1890 275 175 E-mail: bord@pleanala.ie Web: www.pleanala.ie BIOPHARMACHEM IRELAND Tel: (01) 605 1500 E-mail: info@ibec.ie Web: www.biopharmachemireland.ie

Tel: (01) 727 2000 E-mail: client.service@enterprise-ireland.com

ENVIRONMENTAL HEALTH ASSOCIATION OF IRELAND Tel: (01) 276 1211 E-mail: info@ehai.ie

CHAMBERS IRELAND

Tel: (01) 268 0100

Tel: (01) 400 4300

E-mail: info@epa.ie

E-mail: info@chambers.ie

Web: www.epa.ie

Web: www.chambers.ie HEALTH AND SAFETY COMPANIES

AUTHORITY

REGISTRATION OFFICE

Tel: (01) 614 7000

Tel: (01) 804 5200

LoCall: 0818 289 389

LoCall: 0818 452 000

E-mail: wcu@hsa.ie

E-mail: cro.info@enterprise.gov.ie

Web: www.hsa.ie

Department of the Environment, Climate Action and Communications Tel: (01) 678 2444

HEALTH PRODUCTS REGULATORY AUTHORITY Tel: (01) 676 4971 E-mail: info@hpra.ie Web: www.hpra.ie

E-mail: customer.service@decc.gov.ie

HEALTH RESEARCH

Web: gov.ie/decc

BOARD Tel: (01) 234 5000

Department of Enterprise,

E-mail: hrb@hrb.ie

Trade and Employment

Web: www.hrb.ie

Tel: (01) 631 2121 LoCall: 0818 302 121 E-mail: info@enterprise.gov.ie Web: enterprise.gov.ie Department of Housing, Local Government and Heritage Tel: (01) 888 2000 E-mail: qcsofficer@housing.gov.ie Web: www.housing.gov.ie

128

Web: www.ivca.ie

Web: www.enterprise-ireland.com

PROTECTION AGENCY

Web: www.cro.ie

E-mail: ciara@ivca.ie

Tel: (01) 874 6321 E-mail: mandate@mandate.ie Web: www.mandate.ie NATIONAL INSTITUTE FOR TRANSPORT & LOGISTICS (NITL)

Tel: 0044 800 181 4422

Tel: (01) 402 3898

E-mail: dublin@investni.com

E-mail: pamela.obrien@dit.ie

Web: www.investni.com

Web: www.nitl.ie

IRISH BUSINESS & EMPLOYERS CONFEDERATION (IBEC) Tel: (01) 605 1500 E-mail: info@ibec.ie

Tel: +1 (301) 656 5900 E-mail: info@pda.org

Web: www.ibec.ie

Web: www.pda.org

IRISH CLEANROOM SOCIETY Tel: (087) 958 8045 E-mail: info@cleanrooms-ireland.ie Web: www.cleanrooms-ireland.ie

Tel: (01) 231 7100 E-mail: info@hea.ie Web: www.hea.ie

PHARMACEUTICAL SOCIETY OF IRELAND Tel: (01) 218 4000 E-mail: info@psi.ie

IRISH COSMETICS, DETERGENT & ALLIED PRODUCTS ASSOCIATION Tel: (01) 605 1500 E-mail: kevin.maher@ibec.ie Web: www.icda.ie IRISH EXPORTERS ASSOCIATION Tel: (01) 661 2182 E-mail: contact@irishexporters.ie Web: www.irishexporters.ie

HIGHER EDUCATION AUTHORITY

PARENTERAL DRUG ASSOCIATION (PDA)

IRISH MEDTECH ASSOCIATION Tel: (01) 605 1500 E-mail: info@irishmedtechassoc.ie Web: www.irishmedtechassoc.ie

Web: www.thepsi.ie REPAK Tel: (01) 467 0190 E-mail: info@repak.ie Web: www.repak.ie SCIENCE FOUNDATION IRELAND Tel: (01) 607 3200 E-mail: info@sfi.ie Web: www.sfi.ie UCD SCHOOL OF CHEMICAL

IDA - INDUSTRIAL DEVELOPMENT AGENCY Tel: (01) 603 4000 E-mail: idaireland@ida.ie Web: www.idaireland.com

IRISH NATIONAL ACCREDITATION BOARD Tel: (01) 614 7182 E-mail: info@inab.ie Web: www.inab.ie

& BIOPROCESS ENGINEERING Tel: (01) 716 1825 E-mail: SCBE.enquiries@ucd.ie Web: www.ucd.ie/chembioeng

Irish PharmaChem | Industry Buyers Guide 2022


2021 January

2021

February

1

2

3

4

Week 5

4 5 6 7 1 8 2 9 3 10

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1 1 2

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6

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8

7 1 8 2 9 3 10 4 11 5 12 6 13

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26 27 28 29 30 31

2022

February

1

2

3

4

Week 5

33 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18 19 20 21 22 23

24 31 25 26 27 28 29 30

5

M T W T F S S

1

1

2022

M T W T F S S

1 2 3 4 5 6 7

4 5 6 7 8 9 10

11 12 13 14 15 16 17

18 19 20 21 22 23 24

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2023

February

1

2

3

4

Week 5

2 3 4 5 6 7 8

9 10 11 12 13 14 15

16 17 18 19 20 21 22

23 30 24 31 25 26 27 28 29

July

9

Week 31 32 33 34 35

2023 2023 Week 52

23 30 24 31 25 26 27 28 29

2022

2022 August

January

M T W T F S S

2 3 4 5 6 7 8

19 20 21 22 23 24 25

Week 26 27 28 29 30

1 2 3

5

M T W T F S S

1 2 3 4 5

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 29 23 30 24 31 25 26 27 28

6

7

8

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 27 21 28 22 23 24 25 26

2023

2023 August

9

2023

Week 26 27 28 29 30 31 Week 31 32 33 34 35 M T W T F S S

1 2

March

2021

Week 9

2021

12 13 14 15 16 17 18

July

M T W T F S S

1 8 15 2 9 16 3 10 17 4 11 18 5 12 19 6 13 20 7 14 21

5 6 7 8 9 10 11

January

M T W T F S S

8

10 11 12 13

1 8 15 2 9 16 3 10 17 4 11 18 5 12 19 6 13 20 7 14 21

September

22 29 23 30 24 31 25 26 27 28 2021

Week 30 31 32 33 34 35 Week 35 36 37 38 39

22022 022 M T W T F S S

7

2021 August

Week 26 27 28 29 30 M T W T F S S

2021 6

3 10 17 24 31 4 11 18 25 5 12 19 26 6 13 20 27 7 14 21 28 8 15 22 29 9 16 23 30

M T W T F S S

7 1 8 2 9 3 10 4 11 5 12 6 13

14 15 16 17 18 19 20

21 22 23 24 25 26 27

28 29 30 31

M T W T F S S

1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

March

27 28 29 30

2022

Week 9 M T W T F S S

20 21 22 23 24 25 26

10 11 12 13

7 1 8 2 9 3 10 4 11 5 12 6 13

14 15 16 17 18 19 20

September

21 22 23 24 25 26 27

28 29 30 31

2022

Week 35 36 37 38 39 M T W T F S S

1 2 3 4

5 6 7 8 9 10 11

12 13 14 15 16 17 18

March

26 27 28 29 30

2023

Week 9 M T W T F S S

19 20 21 22 23 24 25

1 2 3 4 5

10 11 12 13 6 7 8 9 10 11 12

13 14 15 16 17 18 19

September

20 21 22 23 24 25 26

27 28 29 30 31

2023

Week 35 36 37 38 39 M T W T F S S

1 2 3

4 5 6 7 8 9 10

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30

April

2021

Week 13 14 15 16 17 M T W T F S S

1 2 3 4

5 6 7 8 9 10 11

12 13 14 15 16 17 18

19 20 21 22 23 24 25

October

26 27 28 29 30

1 2 3

4 5 6 7 8 9 10

11 12 13 14 15 16 17

April

1 2 3

M T W T F S S

1 2

3 4 5 6 7 8 9

10 11 12 13 14 15 16

4 5 6 7 8 9 10

11 12 13 14 15 16 17

M T W T F S S

2022

May

18 19 20 21 22 23 24

October

25 26 27 28 29 30

17 18 19 20 21 22 23

24 31 25 26 27 28 29 30

2021

Week 44 45 46 47 48

25 26 27 28 29 30 31

18 19 20 21 22 23 24

Week 13 14 15 16 17 M T W T F S S

2021

1 8 15 2 9 16 3 10 17 4 11 18 5 12 19 6 13 20 7 14 21

22 29 23 30 24 25 26 27 28

2022

M T W T F S S

1

2 3 4 5 6 7 8

9 10 11 12 13 14 15

2022 November

1 2

April

3 10 17 4 11 18 5 12 19 6 13 20 7 14 21 8 15 22 9 16 23

24 31 25 26 27 28 29 30

2023

Week 13 14 15 16 17 M T W T F S S

1 2

3 10 17 24 4 11 18 25 5 12 19 26 6 13 20 27 7 14 21 28 8 15 22 29 9 16 23 30

October

16 17 18 19 20 21 22

23 30 24 31 25 26 27 28 29

2022

M T W T F S S

7 1 8 2 9 3 10 4 11 5 12 6 13

14 15 16 17 18 19 20

May

21 28 22 29 23 30 24 25 26 27

2023

Week 18 19 20 21 22 M T W T F S S

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

2023 November

22 29 23 30 24 31 25 26 27 28 2023

Week 39 40 41 42 43 44 Week 44 45 46 47 48 M T W T F S S

1

2 9 16 3 10 17 4 11 18 5 12 19 6 13 20 7 14 21 8 15 22

23 30 24 31 25 26 27 28 29

2021

M T W T F S S

1 2 3 4 5 6

7 8 9 10 11 12 13

14 15 16 17 18 19 20

December

21 28 22 29 23 30 24 25 26 27 2021

Week 48 49 50 51 52 M T W T F S S

1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

June

20 21 22 23 24 25 26

27 28 29 30 31

2022

Week 17 18 19 20 21 22 Week 22 23 24 25 26

Week 39 40 41 42 43 44 Week 44 45 46 47 48 M T W T F S S

June

Week 17 18 19 20 21 22 Week 22 23 24 25 26

2021 November

Week 39 40 41 42 43 M T W T F S S

May

M T W T F S S

1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

20 21 22 23 24 25 26

27 28 29 30

M T W T F S S

1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18 19

December

20 21 22 23 24 25 26

27 28 29 30

2022

Week 48 49 50 51 52 M T W T F S S

1 2 3 4

5 6 7 8 9 10 11

12 13 14 15 16 17 18

June

19 20 21 22 23 24 25

26 27 28 29 30 31

2023

Week 22 23 24 25 26 M T W T F S S

1 2 3 4

5 6 7 8 9 10 11

12 13 14 15 16 17 18

December

19 20 21 22 23 24 25

26 27 28 29 30

2023

Week 48 49 50 51 52 M T W T F S S

1 2 3

4 5 6 7 8 9 10

11 12 13 14 15 16 17

18 19 20 21 22 23 24

25 26 27 28 29 30 31

= Public Holiday

121 3 year calendar 2021-23 sizeA4 1p.indd 121

19/11/2021 13:07


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