December 2014 l
Vol.13
PHARMA BIO WORLD
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Issue 5
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DECEMBER 2014 VOL. 13 ISSUE 5 MUMBAI ` 150
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6 ď‚ƒ December 2014
Pharma Bio World
FEATURES 10
Advances in Pharmacogenomics Technologies – Dr Nimita Limaye
18
ERP: An Indispensable System for Pharma Industry – Sudheer Nair
22
New Generation Technologies for Effective mAb Characterization – Stephen Luke
18 26
Technological Development in Biological Data Management and Analytics Platforms – Suchitra Eswaran
30
Emerging Technologies in Fighting Diabetes – Jenik Radon, Animesh Agarwal
34
Making the Right Choice for DataMatrix Pharmaceutical Packaging Serialization – Richard Nemesi
22
38
Revolution & Modernization of Compulsory License in Pharmaceutical Industry – Vivek Dave, Shipra Gupta, Sachdev Yadav, Swapnil Sharma
52
Demand, Supply Mismatch and Impediments to International Marketing – A Challenge to Indian Phytopharma Industry – Majeti Narasimha Vara Prasad
NEWS UPDATE 30
57 60
Press Release
61
Biotech News
62 64
34
65 66
Pharma News
CORPORATE AFFAIRS Product Trends Events Diary
BACKYARD Book Shelf Ad Index Next Issue Focus: Pharma Logistics
8 December 2014
Pharma Bio World
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Advances in Pharmacogenomics Technologies Hippocrates said that ‘It is far more important to know what person the disease has than what disease the person has.’ Pharmacogenomics, basically the study of how variations in the genome impact response to therapy, has paved the way for a personalized medicine approach.
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harmacogenomic profiling plays a key role in minimizing the economic burden of drug response with forty to fifty per cent of drugs demonstrated to be still ineffective and side effects, a classic example being that of the blockbuster analgesic drug Vioxx (Rofecoxib) which was withdrawn from the market because of its cardiovascular complications. More than half of the new drugs that are approved have serious, undetected adverse effects at the time of approval resulting in Adverse Drug Reactions (ADRs) becoming the fourth to sixth greatest killer in the US, with more than 100,000 deaths / year and about 2.2 million SAEs / year and contributing to USD 289 b in added healthcare costs per year. Seventy five per cent of Americans have gene-based variations that increase the risk of an ADR and 90 per cent of Americans are known to prefer pharmacogenomic profiling for drug dosing and drug selection 1 .
As early as 1999, the top 10 global pharmaceutical giants created a public SNP database to assess the significance of this variability, through an industry-funded industry academia US nonprofit organization and named it “The SNP Consortium Ltd.” This initiative became a model for the process of drug response monitoring in clinical trials. The Pharmacogenomics Knowledgebase (www.PharmGKB.org) initiated a mission to collect, encode, and disseminate knowledge about the impact of human genetic variations on drug response 2 .
Dr Nimita Limaye V P, R i s k B a s e d M o n i t o r i n g , C D M Medical Writing and Clinical Operations Services, TATA Consultancy Services 10 December 2014
In 2005, the FDA incorporated the guidelines for genomic data submission for drug approval. Presently, the genomic data submission for drug approval is voluntary but with increasing awareness very soon this would be mandatory. Since
then various guidance have been published by the FDA (Oct 13 – Paving the way for Personalized Medicine) as well as the EMA (Reflection paper on methodological issues with pharmacogenomic biomarkers – Nov 11, Approving oncology drugs in the era of personalized medicines, Dec’11) as well as a position paper by the AMS, MHRA, and the Industry on Realizing the potential of stratified medicine, Jul’13. As of June 2014, the FDA relabeled over 140 approved drugs 3 to include genetic information (more than 650 drug-related variants have been identified for their clinical relevance), new drugs are also required to include the same and 50 per cent of all clinical trials collect DNA from patients for use in biomarker development. Genetic diagnostics are becoming critically important as many routine diagnostic tests vary in their degree of specificity and sensitivity. High-throughput genotyping technologies complemented by informatics tools, systems and databases with enhanced data connectivity, and the ability to correlate genotype-phenotype information to drive translational medicine, enabling data sharing, yet ensuring data protection are the need of the day. Setting up a whole-genome sequencing facility and translating the pharmacogenomic data so as to be applicable in a clinical setting are two of the most important challenges faced by the industry today. An all important aspect is the cost-effectiveness of pharmacogenomic profiling. A comprehensive personalized pharmacogenomic profile using wholegenome sequencing is currently costing close to USD 3000, as compared to the cost of testing for a single marker or several markers in a few pharmacogenes (ranging from USD 300 to USD 1500). Speed, low costs, low energy consumption, and simple analysis, as well as portability, Pharma Bio World
Advt New.indd 39
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ked=35791&expand=true&parent=35923), Affymetrix, Santa Clara, CA, USA, are extensively used to help get a clear view of ADMET gene variants. An integrated electronic ‘pharmacogenomics assistant’ has been developed to provide personalized drug recommendations based on identifying pharmacogenomics-related gene variants and linking genotype-to-phenotype pharmacogenomics data, leveraging an integrated data warehouse and using a single-access pharmacogenomics portal, serving as a ‘one-stop shop’ Web-based platform. An automated algorithm drives the matching of patients’ genotype profiles with established and/ or newly discovered gene-variants/ alleles, and based on the inference drawn provides corresponding clinical annotations and dosage recommendations bringing in the personalized translation component. Designing this integrated, yet federated Web information system of pharmacogenomics data sources is a hugely challenging task 3 .
Source: Deciphering next-generation pharmacogenomics: an information technology perspective
are key features of a good genetic diagnostic and most importantly, the ability to close the bench-to-bedside translation gap. An example of a rapid genetic screening test is the Smart Amplification Process (SmartAmp), which helps detect genetic polymorphisms within 30 to 45 minutes under isothermal conditions, without the help of DNA isolation and PCR amplification. It is an isothermal DNA amplification reaction (Mitani et al., 2007, Mitani et al., 2009) requiring five primers 4 . 12 December 2014
Microarray-based assays (e.g. AmpliChip CYP450, the first pharmacogenetic testing device approved by the FDA in 2004 - it assesses genetic markers linked to the function of CYP2D6 and CYP2C19 drug metabolizing enzymes). ( h t t p : / / m o l e c u l a r. r o c h e . c o m / a s s a y s / P a g e s / A m p l i C h i p C Y P 4 5 0 Te s t . a s p x ) , R o che Molec ular Diagnos tic s , Bas el, S w i t z e r l a n d ; a n d D M E T P l u s ( w w w. affymetrix.com/estore/browse/ level_three_category_and_children.
Genotype-phenotype associations can be assessed using PK/PD simulation models using virtual simulation packages such as SimCYP (www.simcyp.com/) and NONMEM (www.iconplc.com/technology/ products/nonmem), or open-source tools such as ‘PKreport’ (cran.r-project.org/ web/packages/PKreport) and ‘WFN’ (wfn. sourceforge.net/wfnxpose.htm) R. Data should also be leveraged from established PGx resources (eg; PharmGKB, CPIC, etc.), and other databases such as ( P u b M e d , d b S N P, d b G A P, C l i n Va r, FINDbase, etc.). Pharmacogenomics is based on the identification of pharmacogenes, which play a role in the absorption, distribution, metabolism, excretion and toxicity (ADMET) of drugs. ADMET genes belong to four main categories: modifiers, phase-I and phase-II metabolism enzymes, and transporters. PharmaADME Pharma Bio World
“Biomarkers and computational techniques are enablers for pharmacogenomics and semantic interoperability to handle different ontologies.” ( h t t p : / / w w w. p h a r m a a d m e . o r g / ) i s a n industry-initiated effort to identify a core list of evidence-based drug metabolizing ADMET genetic biomarkers. Thirty two core, 267 extended, 73 related pharmacogenes, as well as 187 core genetic biomarkers have been identified. The Pharmacogenomics Research Network (PGRN; http://pgrn.org) and the eMERGE consortium (http://emerge.mc.vanderbilt. edu/) are developing a sequence platform targeted to identify 84 of the most significant pharmacogenes in patients (http://icahn. mssm.edu/research/institutes/institute-forpersonalized-medicine/for-researchersand-innovators/nhgri-emerge-consortium/ pharmacogenomics-sequencing-pilotproject). This pharmacogene panel (‘PGRN-seq)’, includes clopidogrel/ CYP2C19, warfarin/CYP2C9–VKORC1 and simvastatin/SLCO1B1. The (NCI), US has announced a set of priorities that include treatment response and adverse outcomes associated with chemotherapeutic agents and other medications used to treat c a n c e r ( v i a t h e Tr a n s - N C I ( N a t i o n a l Cancer Institute) Pharmacogenomics a n d P h a r m a c o e p i d e m i o l o g y Wo r k i n g Group (PPWG Their recommendations include the identification of clinical, socio-demographic, lifestyle and genomic markers related to treatment response and/ or adverse events, the incorporation of PGx markers into clinical trials and the need to address ethical, legal, social as well as data-sharing implications of this research. Companies carrying out pharmacogenomic t e s t i n g i n I n d i a i n c l u d e Av e s t h a g e n , OncQuest Laboratories, Acton Biotech, TCG Life Sciences, Advinus Therapeutics and Jubilant Biosys. An interesting example 16 December 2014
of pharmacogenomics variation is the report that up to 30 essential drugs are not effective on 13 per cent of Northern India’s population, as compared to the South Indian population 5. Variation in the type of drug metabolizing liver enzyme expressed, the CYP-450 enzymes (which metabolize more30 classes of drugs) and the N-acetyl transferases are primarily responsible for variations in drug responses 6. Pharmacogenomics is not yet adequately incorporated into routine clinical practice and there is a need to design information systems that can be updated on an ongoing basis, that can disseminate knowledge, help establish new guidelines, and link the results of pharmacogenomic tests to recommendations for therapeutic interventions. Biomarkers and computational techniques are enablers for pharmacogenomics and semantic interoperability to handle different ontologies, as well as the high speed computing of large volumes of data is key. Pharmacogenomic technologies need to look not only at genomic data, but also address proteomics, metabolomics, and epigenetics, and the use of companion diagnostics or theranostics 7 for assigning therapy is indeed not the future, but very much becoming the present 8. Illumina’s MiSeqDx is the first FDA approved in vitro diagnostic based on NGS for detecting changes in the DNA of the cystic fibrosis trans membrane conductor gene (CFTR). To quote Alberto Gutierrez Director of the Office of IVD and Radiological Health, “NGS is changing the way we look at genomics’ 9.
References: 1) K u m a r N a n d L i m a y e A . ( 2 0 1 4 ) Biomarkers, Social Media and Personalized Medicine: Security and Integration Challenges in Managing the Data Deluge and Data Scarcity, SCDM. 2) Banerjee M. (2011) Is pharmacogenomics a reality? Challenges and opportunities for India. Indian J Hum Genet. 17(Suppl 1): S1–S3. 3) Potamias G, Lakiotaki K, Katsila T, Michael Lee MT, Topouzis S, Cooper DN, Patrinos GP. (2014) Deciphering next-generation pharmacogenomics: an information technology perspective. Open Biology, 4(7): 140071. 4) Ishikawa T and Hayashizaki Y. (2013) Clinical SNP detection by the SmartAmp method. Methods Mol Biol. 1015, 55-69. 5) Krishnan P and Jayaram S. (2014) The foray of Pharmacogenomics-An India Perspective BioMed Research,1.1, 1-6 6) Ghosh R, Ghosh S and Chawla S. (2010) Pharmacogenomics - Practice and challenges. Australian Family Physician, 39.10 7 ) h t t p : / / w w w. b i o s p e c t r u m i n d i a . c o m / biospecindia/news/157500/indiasteps-closer-personalized-medicine. Jahanara P. (2010) India steps closer to personalized medicine. 8) Limaye N. (2013) Pharmacogenomics, Theranostics and Personalized Medicine – the complexities of clinical trials: challenges in the developing world. Applied & Translational Genomics. 17–21 21 9) FDA allows marketing of four ‘next generation’ gene sequencing devices. FDA News Release Nov19, 2013.
Contact: nimita.limaye@tcs.com
Pharma Bio World
ERP: An Indispensable System for Pharma Industry An Enterprise Resource Planning solution (ERP) allows an organization to streamline business processes, improve productivity, reduce operating costs and increase revenue growth. This article highlights the importance of implementing ERP into pharmaceutical organisation to drive huge improvements in the effectiveness by integrating all facets of it’s operations including product planning, development, manufacturing, sales and marketing.
Sudheer Nair CEO Eresource -ERP 18 ď‚ƒDecember 2014
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harmaceutical Industry is the one that always in challenging mode. This is because health is the most precious factor that a life is depend on. As it is said, when wealth is lost something is lost, but when health is lost, everything is lost. Therefore contribution of pharmaceutical industry to the Nation must be viewed with most respect. Unlike any other industry, pharmaceutical industry is always in a change mode. This is due to demand of new medicines in the society with the evolution of new illness and diseases. It is not an exaggeration if we say there no other industry in this world where research and development holds important as in pharmaceutical industry. However, in today’s technologically advanced world, pharmaceutical companies cannot be mute spectators to changing environment that largely can contribute in their research and development and other business process in a sophisticated method. As the whole world in the process of transformation in its each every mode and method, case of pharmaceutical industry is not something different. Today pharmaceutical industry is witnessing key transformation in the working method with the help of highly sophisticated software applications. With the introduction of sophisticated equipment in all working process, managing the work also been upgraded with support of computer networks and highly reliable software applications. This has also been resulted the requirement of highly talented IT professionals in the field. The industry has reason to feel proud that due to this sophisticated working process, the industry has able to invent, produce and supply from very ordinary to even life-saving drugs that our society is badly needed to safeguard their health and other health related matters.
In recent times, ERP or Enterprise Resource Planning solution has played a big role in growth of pharmaceuticals industry, generally in its business process and particularly in its technical process. Pharmaceutical ERP software is tailored to meet the needs of pharmaceutical organization. Primarily, this application can deliver the power, scalability, and robust e-business functionality in a cost effective m a n n e r, w i t h r a p i d i m p l e m e n t a t i o n . Most of these application comprises versatile analytics and MIS reports, which gives the power to run businesses at peak performance. When we talk of an ERP system for pharmaceutical company, the first question will be is an ERP system must for a pharmaceuticals company? If yes, why they need it? The answer is simple. Today ERP solution functions are the soul of an industry, whether it is pharmaceutical or others. And important of soul is beyond any simple explanation. Rather than just a business application ERP mainly functions as a system that automates industry process. Automatic proc es s make s it p o s s ib le that everything work according to plan and every medicine is produced with its optimum scrutiny and manufactured medicines are delivered to the proper place also at proper time and all other business process related execution carried out efficiently. With an ERP system in place, chances of human error are rare or dim. This system also ensures safety and quality of the product in internationally acclaimed standard. As the enterprise resource planning software became a key component for pharmaceutical companies to integrate their entire business processes, good Indian ERP companies have introduced Pharma Bio World
Pressure Range
Capacity
Discription
Sr No
M3/Min
CFM
Bar
1
Lubricated SCREW Compressor
0.23 to 43.70
8 to 1545
8 to 13
2
Oil Free SCREW Compressor
5.30 to 51.40
187 to 1815
8 to 10
3
Lubricated PISTON Compressor
.125 to 6.20
4.5 to 219
8 to 40
4
Oil Free PISTON Compressor
.156 to 1.30
6 to 45
8 to 40
5
BOGE FLEXPET
1.55 to 17.9
54 to 634
40
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“Implementation method plays an important role in success of an ERP system for pharmaceutical industry. Successful implementation requires a structured methodology. The method should be people and process-focused.� some affordable and effective system to suit the need of small and medium sized companies in the Indian market. The most popular among them is the web-based pharmaceutical ERP systems which is a big hit among all big and small companies alike. These Web-based ERP systems integrate and automate the main functionality of an organisation thereby facilitating the flow of information among the different functions of an enterprise. These webbased systems have been developed to support all major pharmaceutical business operations. The systems have
20 ď‚ƒDecember 2014
been incorporated with many advanced individual modules that could take care of functioning of every department efficiently. Quality Management tops the priority list as far as any pharmaceutical company is concerned. Keeping this in mind these systems are developed and designed in unique style. Quality Control department with its integrated sophisticated Quality Control/Module which not only monitors quality by control plans in purchasing and production but also provides real-time process capability index for quick review. Implementation method also plays an im p ortant role in s uc c es s of an ERP
s y s t e m f o r p h a r m a c e u t i c a l i n d u s t r y. Successful implementation requires a s t r u c t u r e d m e t h o d o l o g y. T h e m e t h o d should be people and process-focused. This is the best way to manage the risk effectively. A good methodology of implementation process covers all the bases. Therefore if there is anything unexpected pops up the user will be able to handle these problems without any negative consequences. Web-based ERP system for pharmaceuticals is a more flexible, affordable and reliable. What is more important is that for a successful pharmaceutical business process, ERP is the future, and it has become essential in the business world because it brings information classified and simplified to those who have to make decisions.
Contact: pushkala@mediacompr.com
Pharma Bio World
New Generation Characterization Monoclonal antibodies (mAbs) have become a major part of the growing biologics drug market. Because of their inherent complexity and for safety reasons, there is a need to develop powerful analytical methods to provide detailed characterizations of mAbs. This article reviews new analytical techniques for effective mAb characterization.
Technologies
for
B
iopharmaceuticals are compounds from a biological source, such as proteins and peptides, which have been formulated for therapeutic use. While biopharmaceuticals are not a new market it is a rapidly growing field and one area in particular that is receiving increased attention are monoclonal antibodies (mAbs). Growing at a rate of 18 per cent and representing 32 per cent of the biologics market, there has been a significant shift in emphasis and spend on the development of mAbs for the biologics pipeline. mAbs are designed to attach to binding sites with high specificity but any changes in primary structure can have a negative impact on efficacy and immunogenicity. The full characterization of mAbs is therefore essential but it is a complex and multi-step process that requires multiple techniques. Drivers for New Biopharmaceutical Technologies In recent years there has been a dramatic shift within the pharmaceutical industry towards the development of biopharmaceuticals. The global pharmaceutical/biopharmaceutical industry is expected to grow in value from USD 830 billion in 2012 to USD 980 billion in 2017 and the biopharmaceutical market share is set to almost double from 18 to 31 per cent. The biopharmaceutical industry operates on a global scale with North America (35.9 per cent) and Europe (26.1 per cent) representing the highest concentrations of biopharmaceutical manufacturing. The growing demand for biologics has resulted in a number of business mergers and acquisitions to enable increased investment and scale-up of production to fill the biologics pipeline.
Stephen Luke LC Columns Product Manager Agilent Technologies 22 ď‚ƒDecember 2014
The increasing focus on the development of biopharmaceuticals has meant that both large and small pharmaceutical and biopharmaceutical companies as well as CROs have had to consider the techniques
Effective
mAb
and technologies they use to achieve reliable, accurate, reproducible results. Due to the complexity of biological materials, regulatory bodies require the absolute and accurate characterization of biologics and new technologies have been developed in order to provide the accurate, highthroughput and robust analysis required. Laboratory technicians and researchers have had to consider their workflows and analysis methods for biomolecules with which they may have only had limited experience before. The key challenges for those involved in biopharmaceutical analysis are achieving excellent accuracy quickly, complete characterization to meet regulatory requirements and reliable results to ensure product consistency. Liquid chromatography (LC) methods that enable the effective characterization of mAbs are required to support the development of mAb biotherapeutics during late drug discovery, early drug development and QA/QC. In addition, the need for faster analysis methods has led to a move towards UHPLC and smaller particle size columns. Protein biopharmaceuticals are heterogeneous a number of chromatographic techniques may be required for full characterization. Methods include size exclusion chromatography (SEC) for the quantitation of dimers and aggregates, and ion-exchange (IEX) chromatography for the identification of charge variants. Reversed-phase (RP) liquid chromatography and hydrophilic interaction chromatography (HILIC) are also key techniques used in biochromatography. In the race to bring new therapeutics to market, the availability of fast and accurate techniques for the characterization of mAbs is paramount. Challenging mAb Characterization From choosing the right sample preparation technique, to the most appropriate column Pharma Bio World
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“The global pharmaceutical/biopharmaceutical industry is expected to grow in value from USD 830 billion in 2012 to USD 980 billion in 2017 and the biopharmaceutical market share is set to almost double from 18 to 31 per cent.” for protein separations, there are a number of key factors to consider in order to successfully overcome the challenges associated with mAb characterization. The biochromatography industry has risen to the challenge of developing the technology required to deal with the specific analytical challenges of each stage of the characterization process. There are four key considerations to achieve full mAb characterization including; establishing the primary structure of a mAb, identifying glycosylation patterns, analyzing charge variants and monitoring aggregation levels. Each of these steps is essential to establishing the efficacy and toxicity of a biopharmaceutical early on in the development process to avoid major, and expensive, setbacks downstream. Column selection, column quality, mobile phase selection and detection requirements are all crucial to achieving high quality, reproducible and robust separations. Two of the most significant developments have been in improvements in the technologies
available for peptide mapping, which is part of the process involved in establishing the primary structure of a protein, and glycan mapping. Despite the fact that run-to-run reproducibility and stability are essential for maintaining robust peptide mapping separations, the quality of the column used is often overlooked. Smaller diameter fully porous column materials using slower flow rates are the popular choice for the separation of peptides which has led to an increase in sub-2µm packings, achieving more efficient peptide maps. However, superficially porous columns, such as the Agilent AdvanceBio Peptide Mapping column, have recently become the column of choice for biological separations in biopharmaceutical applications because they address the limitations of protein and peptide mass diffusion. Peptide maps rely on repeatable operation of the column for delivering precise mapping fingerprints and repeated validation protocols so when
choosing a column for peptide mapping, column quality should be at the forefront of the decision making process. The glycosylation patterns of mAbs have a significant impact on the efficacy of a biotherapeutic drug. Glycan mapping is therefore an essential part of the mAb characterization process but it is a complicated and multi-step process. Glycans are hydrophilic structures so hydrophilic interaction chromatography (HILIC) using fluorescence detection, is a robust separation method for glycan analysis. One of the biggest challenges in HILIC/LC is achieving high-resolution with fast analysis times without compromising performance. Rapid, reproducible and high resolution glycan mapping is now achievable thanks to developments in column technology. One of the new generation columns is the Agilent AdvanceBio Glycan Mapping column which has a unique bonding that uses a HILIC mechanism to support glycan separations to achieve high speed performance. Glycan maps can now be obtained in less than ten minutes with 1.8µm particles. This reduction in analysis time is a significant benefit when analyzing and characterizing a large volume of samples during process development. A Bright Future for Biopharmaceuticals In the drive to reduce the time and costs associated with the development of biopharmaceuticals, researchers cannot compromise on analytical accuracy. Patient safety is paramount which makes the complete and accurate characterization of mAbs essential to the delivery of the next groundbreaking biotherapeutic. New technologies for the characterization of mAbs provide the selectivity, resolution and reproducibility required to enable researchers to meet regulatory requirements, avoid costly rework and continue to innovate in the field of biopharmaceuticals.
Contact: ham@scottpr.com 24 December 2014
Pharma Bio World
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Technological Development in Biological Data Management and Analytics Platforms As biological research has increasingly turned into a datarich area, the need for storing and communicating large datasets has grown tremendously. In order to make these heterogeneous data sources easy to use, several efforts at data management are currently being undertaken.
B
i g Da ta i s t h e n e w p ara d i g m i n biological research. With the advent of genomics, proteomics, metabolomics, clinical data, and electronic health records, life scientists are struggling with enormous data sets, largely unstructured. Biological Big Data refers to high-volume, high-velocity, and high-variety complex data sets requiring technology to collect, store, process, manage, organise, and analyse information to glean insights and consequently help in decision making. It all started with the completion of the Human Genome Project, more than a decade ago. Genetic mapping is generating huge data sets in form “omics” data banks. The sheer size of these data banks or data libraries can be conceptualised by a simple fact that a single sequenced human genome is around 140 gigabytes. With the development of targeted therapies and personalised medicine, one can only imagine the volume of “omics” data in the world.
Suchitra Eswaran Vice President-Life Sciences Blueocean Market Intelligence 26 December 2014
Drug development is also undergoing changes in recent times. Drug development firms are leaving no stone unturned and are putting every piece of data, structured or unstructured, under scrutiny. One can easily imagine that the cost of development of new drugs, price pressures from the regulatory and health technology assessment bodies, and economic situation across the globe put enormous pressure on innovators to adopt effective and efficient processes for drug development. There is a radical change in the way companies want clinical data analysed. It also builds pressure for market research firms such as ours and provides opportunity to constantly innovate and improvise the way we analyse data sets. Another attribute of the big data is its c o m p l e x i t y. D a t a s e t s i n b i o l o g y a r e
far more heterogeneous than those in physics. Data from different experiments lead to many types of information, such as genetic sequences, protein chemistry, molecular interactions, and patient records, just to name a few. This highly variable information needs to be analysed and interpreted in light of prior knowledge. In any clinical trial, patient data needs to be compared with each other and also across prior information available for longitudinal analysis. If data sets contain genetic sequencing or protein interactions to be compared for pattern recognition, the complexity is daunting. Several data management platforms have been developed to facilitate data analysis in healthcare settings. Companies such as Oracle, Accenture, and IBM have been instrumental in providing tools to life scientists to digitize published or nonpublished literature, enable text search, visualise outputs, and develop models and frameworks. Platforms such as of electronic laboratory notebook (ELN), laboratory information management system (LIMS), sequencing data banks, omics libraries, clinical data collection (OpenClinica), electronic case report forms (eCRF), tranSMART, and electronic patient health records developed by these firms are playing pivotal roles in modern day biological research. A whole array of omic libraries and data banks such as COSMIC, dbGaP, GEO, ArrayExpress, or TCGA have been created to facilitate research and manage data sets. It is very reassuring to see the academia and industry worldwide collaborating i n a d v a n c i n g t h e b i g d a t a b i o l o g y. I t indeed needs concentric efforts from all. Toward attaining this, much of the construction in big data biology is focused on cloud computing, which enables remote Pharma Bio World
access of information to all, saving the huge investments on hardware at local establishments. The idea is to facilitate research, particularly in an era of reduced f u n d i n g . I n a d d it io n t o He lix Ne b u la , a cloud-based infrastructure ideated by European Bioinformatics Institute (EBI) in collaboration with European Organisation for Nuclear Research (CERN) and European Space Agency (ESA) with IT partners, private companies such as Accenture and Oracle (The Life Sciences Cloud) are entering the domain. However, cloud computing has its own challenges; one of the biggest being
safety and security of the data stored and monitoring the access rights, which is why most drug developers are hesitant of using the cloud. But I firmly believe that early hesitation will move toward total acceptance as the advantage of using cloud-based data management systems is overwhelming. The cost–benefits and potential to overcome logistical barriers will give cloud-based system the thrust i t n e e d s t o p r o p e l . M o r e o v e r, t h e formation of international consortia for e ff o r t s s u c h a s e T R I K S D e l i v e r a n d BioMart only reinforces the idea of collaborative research.
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The world of big data in biology is moving at an immense pace and changing the way biological research is done. The traditional “wet labs” are now changing to “dry in silico labs. A bright future lies ahead for big data analytics in biology, where IT platforms bring multiple internal and external data sources across functions (clinical, s a f e t y, r e g u l a t o r y, a n d o p e r a t i o n a l ) , into a single analytics platform, thereby creating actionable insights to accelerate drug development, contain development costs, and improve patient outcomes. However, we still need high computational capacity to analyse heterogeneous data at high speed and skilled data scientists to undertake such high-end analytical research. Nevertheless, big data biology presents ample opportunities for efficient use of information in effective personalized healthcare.
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“Data sets in biology are far more heterogeneous than those in physics. Data from different experiments lead to many types of information, such as genetic sequences, protein chemistry, molecular interactions, and patient records, just to name a few.”
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28 December 2014
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Emerging Technologies in Fighting Diabetes Diabetes is a globally prevalent disease impacting 10 per cent of adults in the world. Regular selfmonitoring allows diabetes patients to keep track of their blood glucose levels and better control the potential complications of their disease. However, the inconvenience caused by repeated fingertip pricking in use of portable glucometers have led to low patient compliance. This article discusses the various technologies under development for painless and convenient self-monitoring of blood glucose levels, the future of these technologies and how they may impact diabetes management in the next decade.
Jenik Radon Adj. Professor, School of International and Public Affairs, Columbia University New York, USA
Animesh Agarwal Analyst, Ventureast Venture Capital Private Limited, Hyderabad, India 30 December 2014
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iabetes can be found in every c o u n t r y. 4 0 0 m i l l i o n p e o p l e i n the world are estimated to have diabetes today. If these trends continue, by 2035, nearly 600 million people, or one adult in ten, will have diabetes. This equates to approximately three new cases every ten seconds, or almost ten million per year. The largest increase will take place in India and other regions where developing economies are predominant. As of 2013, ~80 per cent of diabetics live in low- and middle-income countries. India, with an estimated 65 million diabetics, has a devastating statistic as it has second largest population of diabetics in the world (after China). Diabetes is also an economic disaster for many nations as it is the second largest disease (after cancer) in terms of world healthcare expenditure; amounting to an incredible USD 550 billion annually. A large part of healthcare expenditure in diabetes patients goes towards management of debilitating complications such as neuropathy, retinopathy, kidney failure and death. A person with diabetes can live for several years without showing any symptoms. During that time high blood glucose is silently damaging the body and diabetes complications may be developing. The complications associated with diabetes are so varied that even when symptoms do exist, diabetes may not be recognised as the cause unless accurate and appropriate testing is carried out. Early diagnosis and good glucose control using regular glucose monitoring can significantly delay the onset of diabetes complications and can lead to significant improvement in a patient’s life. There is unfortunately no “cure” for diabetes. The primary objectives of clinical management of diabetes are delaying the complications and diminishing the impact of complications to ensure good quality
of patient life. Regular self-monitoring of blood glucose is the most important way this can be achieved. Current Methods Perhaps the biggest breakthrough in regular glucose self-monitoring came through the popularisation of portable glucometer with an enzyme-based direct blood glucose measurement using a blood drop from a fingertip. However, low patient compliance with the portable glucometers is a major challenge. Protocols prescribed by the Mayo Clinic and by the American Diabetes Association in the US suggest that insulin dependent diabetes patients should monitor blood glucose at least 6 times a day. Most diabetes patients in India (even those dependent on insulin) perform only 1-2 tests a week. This low patient compliance is primarily due to the inconvenience and soreness caused by the repetitive puncturing of the fingertips. There are several technologies under development around the world to address the regular blood glucose monitoring needs of diabetes patients. Emerging Technologies The simplest of the alternate blood glucose tests is called alternate site testing. In this, patients use a regular (or modified) glucometer strip with blood drawn from body parts other than the finger tips. These alternate sites can include thighs, upper arm, fore arm, calf and base of thumb etc. A challenge with using alternate site testing is that the glucose concentration in the blood drawn from alternate sites correlates weakly with the glucose concentration in the blood drawn from fingertips. The traditional clinical protocols in place are based on the blood glucose readings from Pharma Bio World
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There are technologies under development which assay surrogates such as protein glycosylation levels in saliva to estimate a patient’s blood glucose levels. the fingertips. As a result, the alternate site readings need to be used with caution. A new technology under development for painless and convenient glucose monitoring is called trans-dermal testing. In this, a patch is placed on a patient’s skin and the patch uses electromagnetic fields to draw tiny amounts of fluids from the skin to test for glucose in that fluid. This process is usually painless and can be used for collecting several readings throughout the day. Work is under progress on improving the accuracy of these tests. No such device has received clearances from regulatory bodies such as US Food and Drug Administration (FDA), European Medical Agency (EMA) etc, owing to concerns of specificity and sensitivity. A related set of technologies under development can broadly be clubbed under the name of remote glucose sensing. These technologies aim to measure blood glucose remotely ie, without extracting any fluid form the body. These technologies typically measure the subtle changes in externally observable physical properties such as infrared spectrum, electromagnetic interference patterns, thermal or electrical conductance, optical coherence characteristics, ultrasound interactions and laser reflection patterns etc, with changes in blood glucose levels. These technologies have achieved varied degrees of success so far in clinical trials conducted across the world, which by definition makes it costly in time and money to develop them. A US based company has received CE-mark approval for a device that uses a combination of infrared, electromagnetic waves and thermal conductance and has made a 32 December 2014
limited market launch in few European countries. Another US-based company has advanced clinical data with its electrical conductance and laser based device and is expected to launch the product in the market early next year. The key challenge for remote glucose sensing technologies is to establish a functional relationship with the traditional blood-based direct glucose measurements. Another challenge is to create awareness among patients and clinicians and to establish clinical protocols around use of measurements obtained from remote glucose sensing technologies. So public education is key. Another set of technologies under development aims to facilitate convenient glucose self-monitoring by testing for glucose in externally available body fluids such as saliva, urine, sweat and tear etc. Recently and surprisingly, a large US internet company has expanded its business by partnering with a large life sciences company in the diabetes monitoring space to develop a smart contact lens which can continuously measure glucose in the tear and keep diabetes patients informed of their bloodglucose levels. There are also technologies under development which assay surrogates such as protein glycosylation levels in saliva to estimate a patient’s blood glucose levels. A key feature of the several of these emerging technologies is that they lend themselves easily to the growing base of digital technologies that let patients and their care givers store, manipulate and analyse medical data. The remote glucose sensing devices typically beam their
recorded data to a central server in the cloud where it is archived and analysed for patterns that help physicians understand the effectiveness of treatment. High Risk Space with Potential for Big Returns The developments in glucose selfmonitoring space is primarily being driven by young technology companies in India and elsewhere; founded and run typically by multidisciplinary teams comprising clinicians, scientists and engineers and guided and supported by lawyers and investors. This is a fast changing space characterised by developments in biomedical engineering, material sciences, electronics, communication systems, data management systems, cloud computing platforms and novel biosensing mechanisms. Young companies are by definition nimble in adapting to this changing technology landscape. Most of these companies have been funded by leading life sciences venture capital investors from around the world – investors willing to take a chance in an area which should morally be supported by public agencies. One estimate suggests that more than USD 500 million has been invested in technology development alone. This is still not enough given the necessary regulatory requirements. Nearly twenty companies from around the world are in a race to provide the perfect solution for this critical problem that faces effective diabetes management today. And there will be more. This is a game of high stakes, with an opportunity to promote public good, and one where the winner may reap substantial financial rewards! In this case, what is good for the investors is also good for the patient and the public. Contact: jenik_radon@radonoffices.com Pharma Bio World
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Making the Right Choice for DataMatrix Pharmaceutical Packaging Serialization This article investigates important considerations to evaluate before implementing the best marking technology.
T
he impact of the DataMatrix code in the pharmaceutical industry has been immense. Offering high standards of data quantity and security, this two-dimensional matrix barcode has become the standard code carrier for a number of regional and countryspecific serialization initiatives. Now with pharmaceutical, life sciences and healthcare packaging operations being held to ever more demanding internal standards and industry requirements, DataMatrix is perfectly placed to deliver the requisite high-resolution, content-rich codes needed to address these challenges. Life sciences packaging, in particular, has driven innovation in the coding and marking industry, where high resolution printing, serialization and printer cleanliness have called for rapid equipment development and new print technologies. With packaging engineers and managers now facing wider technology choices, it is vital for manufacturers to implement a properly specified and selected, yet unobtrusive, printing solution. With increasing frequency, packaging leaders are being asked to specify between the two most common print technologies for serialized marking: laser and thermal ink jet (TIJ). Choosing the Right Technology for Your Packaging Requirements
Richard Nemesi Global Vertical Marketing Manager Pharmaceutical and Medical Devices Videojet Technologies 34 December 2014
Both laser and TIJ printing provide highresolution codes suitable for the detail required for DataMatrix symbols and multi-line printing. TIJ printers fire tiny ink drops onto the packaging as it passes by the cartridge, or printhead. These ink drops are propelled out of a row (or rows) of fine-gauge nozzles by the rapid
cycling of a small resistor, which is located underneath each nozzle. The resistors ‘boil’ a small amount of ink which creates a small steam bubble that then propels the ink drop. In contrast, laser printers use a focused beam of light to inscribe or physically alter the top layer of a substrate. The beam of light is steered by two mirror galvanometers which direct the laser beam in two planes. Critical success factors in identifying the right technology for a given application fall into five key criteria: 1) Substrate or Material: The material being marked-the substrate-should be the first criterion considered. Historically, TIJ technology featured only water-based ink, meaning adhesion could only be achieved on porous and semi-porous s ubs trates . Rec ently ne w te c h n o lo g y has been developed featuring methyl ethyl ketone (MEK)-based TIJ ink. This makes TIJ a viable alternative for many non-porous substrates, including cartons and paper label stocks with aqueous overcoats, which are common in pharmaceutical applications. Packaging suppliers can also modify the last step in the printing process to avoid placing the aqueous overcoat over the print window (referred to adding a “knockout”), which opens up water-based ink alternatives as well. Laser technology offers a greater substrate range with the potential to mark on paper, plastic, metal and glass. However, testing the application is recommended to identify how the substrate absorbs laser light and if sufficient contrast is created for code legibility. For optimum results, packaging can be specified to boost reflectance, Pharma Bio World
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thereby improving bar code contrast and readability. 2) Packaging Line Speed: Given the valuable assets used for packaging in this space, ensuring the printer will not sacrifice line efficiency is vital. For TIJ, this is a simple calculation governed by the selected print resolution of the code and the maximum speed at which the resistors can be turned on and off. Factors, such as the complexity of the code, do not impact packaging line speed. This is especially valuable for manufacturers who anticipate printing additional coding information in the future. Laser throughput capability depends on several factors such as code complexity, marking field size and substrate type that all influence the throughput. That said, comparable speeds can be achieved in both technologies for most applications. 3) Substrate Handling and Transport: Both lasers and TIJ printers require smooth, vibration-free transport of the substrate in order to provide the highest quality output. When properly implemented, both technologies can operate in continuous and intermittent (stop-and-go) packaging applications. An advantage of laser technology is its ability to print on the package while it is moving or stationary, while TIJ requires the substrate to traverse across the front of the printhead. Alternatively, the TIJ printhead can be physically traversed across a stationary substrate, but this adds some mechanical integration to the packaging line.
4) Installation: Laser marking technology requires two additional considerations for proper and safe installation: beam enclosures and fume extraction. For operator safety, enclosures around the laser energy beam need to be installed to prevent access. The ablation process for laser marking creates a small amount of fumes containing small particulates and gases that may be a health hazard; deploying a fume extractor with a filtration unit is best practice. For MEK-based T I J i n s t a l l a t i o n s , e ff e c t i v e c a r t r i d g e management is crucial to producing a high quality codes without printhead intervention. Recent innovation includes cartridge management systems which automatically close during line stoppages and open when product flow resumes, to assure code quality.
and laser can be competitive solutions, however TIJ has a lower capital cost – an advantage that is magnified whenever multiple print locations are required on a given substrate. Laser technology benefits from eliminating the need for inks, but will require periodic filter replacements. As such, a customized comparison will ultimately decide which technology is more cost effective.
5) Cost (Capital and Operating): In all business equations, cost is always a key consideration – not just the initial capital investment but also the running cost. In terms of total cost of ownership (TCO), TIJ
There is no single criterion which tips the decision in one direction or the other. There are however several important considerations to evaluate before implementing the best marking technology. Business and specific needs, such as anticipated future use and accessing application-optimal recommendations, are important to making an informed decision and ultimately making the right choice.
“Life sciences packaging, in particular, has driven innovation in the coding and marking industry, where high resolution printing, serialization and printer cleanliness have called for rapid equipment development and new print technologies.” 36 December 2014
The Final Choice It is no small task to evaluate coding technologies to print highquality alphanumeric and DataMatrix codes – and companies seeking to incorporate or expand their use of this versatile barcode solution are left to consider myriad of factors.
Contact: sli@abipr.com Pharma Bio World
Revolution & Modernization of Compulsory License in Pharmaceutical Industry Compulsory licensing has been observed as a remedy to prevent misuse of exclusivity of intellectual property rights. The article gives brief descriptions on international laws of compulsory licensing and outlines TRIPS agreement which provides protection from misuse of patent innovation and the effect of compulsory licensing in India and globally with the intellectual property rights regime.
Vivek Dave
Department of Pharmacy Banasthali University
Shipra Gupta
Department of Pharmacy Banasthali University
Sachdev Yadav
Department of Pharmacy Banasthali University
Swapnil Sharma
Department of Pharmacy Banasthali University 38 ď‚ƒDecember 2014
A
compulsory licensing is instinctive agreement between a willing purchase and an unwilling suppliers enacted by state. In intellectual property rights of compulsory licensing is contracted on certain basis some are like patents which do not work in country, excessive raise in prices of essential product, intellectual property rights holder exercising its rights which affects the public interests. The compulsory licensing has been delegated by various international treaties such as WTO, TRIPS, WIPO and Paris convention for protection of intellectual property rights which provides with socio commercial economic growth and health factor in p u b lic s ec tors . Compuls ory lic ens ing provides that the proprietor of patent or copyright licenses to use their rights against payment either set by rule or by some form of negotiation. In compulsory license an individual or enterprise seeking to use another person intellectual property can do so without seeking the intellectual property right owner ’s agreement and pays the right owner a set payment for the license. Governments can issue compulsory licenses for someone else to produce the patented product or can use the patented process without the a g r e e m e n t o f t h e p a t e n t h o l d e r. T h e granting of compulsory licenses without the approval of the patent owner can be done under certain circumstances intended for protecting the genuine benefits of the patent owner more over compulsory licenses should be approved mainly to supply the national market. In cases such as anti competitive interests, national emergency and public noncommercial use there is no need to apply for voluntary license in advance. Copyright or patent owners may only use the exclusive rights granted under copyright law and patent law in a certain way and through certain system [1-2] . The international law of compulsory licensing was showed in
figure 1. Compulsory licensing allows countries to produce patented foreign innovations without the approval of the foreign patent holders. Compulsory licenses came into force as the developing countries could not afford the cost of technology to produce medicines and high price incurred due to the discovery, which could not be afforded by the national market [3] .Under UK patent law, a compulsory license is different from a statutory license under which statutory license rate is fixed by law, whereas in case of compulsory license, the rate is left to be negotiated [4-5] . Compulsory Licensing of IPR and its Effect To replicate, execute, or distribute a copyrighted work, approval must be a c q u i r e d f r o m t h e c o p y r i g h t h o l d e r. However, in a few situations recognized as compulsory licenses copyright owners permission is not essential provided that the user follows definite rules and recompenses set by law. Such compulsory licenses are commonly used by satellite television suppliers, webcasters and cable providers and music companies. One of the maximum uses of a compulsory license is in the music companies. Once a song has been recorded and distributed to the public, any individual or group of persons are allowed to record and distribute the song without obtaining the copyright holders agreement, only if they pay a fee and meet copyright law necessities. In order to take benefit of this compulsory license, a notification must be sent to the copyright holder along with a fee set by the copyright office known as the statutory fee [6] . The Berne convention provides for statutory compulsory licensing below certain conditions. In this performer rights concerning the transmission of their program via broadcasting, telephone Pharma Bio World
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Figure 1: Compulsory licensing in international laws
or other corresponding apparatus are preserved. Under article 80 of the berne convention performers do not have an exclusive right to prevent these procedures of misuse but they are authorized to rightful compensation for such usages. Compulsory licensing is generally defined as granting of a license by a government to use a patent without the patent holders permission [7] .Essential to patent rights is the granting of exclusive rights to the patent holder. These give him or her power to prevent third parties from using, producing or commercializing the protected invention. A typical feature in most patent laws has also been to provide for exceptions to exclusive rights, by specifying categories of acts relating to the patented invention that third parties are allowed to undertake without the authorization of the patent holder. Such acts generally include, for instance, the use of the invention for private purposes, for teaching and for scientific research. In the case of pharmaceutical patents, some countries specifically permit the initiation of procedures for the registration of a medicine by a third party before the expiry date of the respective patents, so as to speed up the commercialization of a generic product after that date [8] . Compulsory licenses also limit the exercise of the patent rights, but they do not work in the same way as exceptions. A compulsory license allows the use of an 40 ď‚ƒDecember 2014
invention but only by the person that has been so permitted by an authority after determination that certain requirements established by the law are met. Both the request for a compulsory license and its use may be subject to time restrictions and to the payment of compensation to the patent holder as well. Compulsory licenses are generally nonexclusive and subject to the granting of compensation for the patent owner [9] .Holding ownership to a patented invention means one has certain exclusive rights, a) the right to decide who may use the invention during the time of protection, b) the right to give licenses to other parties to use the invention on mutually agreed terms and c) the right to sell and transfer ownership of the patent to someone else [10] . Once this patent expires, the invention would enter the public domain to be shared freely [11] . A compulsory license can be granted, in which authorization is given by national authority to a person without or against the consent of the t i t l e h o l d e r, f o r t h e e x p l o i t a t i o n o f a subject matter protected by a patent or other intellectual property rights [12] .Paris Convention gives right to grant compulsory licenses to prevent abuses which might result from the exercise of exclusive rights conferred by the patent‌ “As 2014, the convention has 176 contracting member countries. Compulsory licenses can only be done after 4 years of applying for the patent, or 3 years [13] .
Compulsory Licensing in India Patent Paw The limit of compulsory licensing covers patented products as well as patented processes. The Indian Patent Act gives a pointer to the objects of compulsory licensing and requires that while granting a compulsory license, the general conditions in the section have to be focused on the working of patents [14] . The Indian law provides for the grant of a compulsory license under Section 84, aiming to prevent the abuse of a patent as a monopoly and to make way for commercial exploitation of invention by an interested person. The grounds that may be vouched to apply for the same include the reasonable requirements of the public with respect to the patented invention have not been satisfied, the patented invention is not available to the public at a reasonably a ff o r d a b l e p r i c e . T h e a p p l i c a t i o n f o r compulsory license the nature of the innovation, the time which has intervened since the sealing of the patent and the measures already taken by the patent or licensee to make full use of the invention, the ability of the applicant to work the invention to the public advantage, the capacity of the applicant to undertake the risk in providing capital and working the invention, if the application were granted. In the conditions of national emergency or extreme urgency or public noncommercial use including public health emergencies, Pharma Bio World
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Patent Act 1970 Section 92.A Compulsory license for export of patent N/A but has threatened Bayer for compulsory pharmaceutical products in certain exceptional circumstances:” shall l i c e n s i n g o f C i p r o f l a x i n m e d i c i n e w h o be available for manufacture and export of patented pharmaceutical subsequently dropped their prices drastically. products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems…”
Table 1. Compulsory license comparison between India and US (Reichman J H et al 2009).
ability to protect public order or mortality, including protecting health. Article 8 of TRIPS allows member countries to adopt measures to protect public health and nutrition and to prevent the abuse of intellectual property rights [28] . Article 30 allows member countries to provide limited exceptions to patent rights and to prevent abuse of fair use of copyrighted materials [29] . There are three substantive requirements in Article 30 that must be met for there to be an allowed exception to patent exclusivity. An exception is it must be a limited one, cannot unreasonably conflict with a normal exploitation of the patent and cannot unreasonably prejudice the legitimate interests of the patent owner, taking into account of the legitimate interests of third parties [30] . Article 31 of TRIPS agreement deals with compulsory licensing in case of patents which allows authorization under certain conditions such as in case of national emergency, public noncommercial use, nonexclusive and non assignable use and payment of adequate remuneration to patentee etc [31] . TRIPS describe a set of circumstances that establish a floor at which any Member State is allowed to issue compulsory license. The compulsory licenses that are allowed fall into two groups where there is an intervening public interest or where the patent rights are being used in an anticompetitive method. TRIPS handle compulsory licenses as an exception to the agreement’s minimum condition that all Member States afford a patentee a right of exclusivity during the complete patent term [32] . Examination of compulsory licensing in TRIPS agreement notes that its patent provisions must comply with the 46 December 2014
Paris Convention of 1967. Compulsory license for patented innovations such as preventing abuse of patent inventions to secure its exclusivity make a way for commercial exploitation of a patented innovation and with concerned to public health in India and internationally. Compulsory Licensing of Doha Declaration Doha declaration in 2001 sought to determine the issue of use of compulsory licensing to export drugs to developing countries. It lays down certain general principles and deliberates certain rights. It also recognizes the need to address public health complications affecting many developing. The European commission’s official journal published guideline 816/2006 which brings into force the requirements of the Doha Declaration [33-34]. The declaration allows compulsory licenses to be issued in developed countries for the manufacture of patented drugs, provided they are exported to certain nations. However, it should be noted that this is not limited to only least developed countries every nation that is a member of the WTO has the right under the TRIPs agreement to issue a compulsory license if there is a public health need [35] . Hurdles Generated in Current Compulsory Licensing Difficulties generated in current compulsory licensing are discouragements against using compulsory licensing by emerging nations, practical hindrances and substantial dependence on willpower of exporting country.
Discouragements against using compulsory licensing by developing nations are not to gain benefits mainly due to some political reasons. Many developing countries choose not to issue compulsory license as it can hinder trade relations or intellectual rights [36] . Small income countries such as Thailand, Columbia and South Africa etc. are pressurized by developed countries to adopt more rigorous intellectual property rights law [37] . Practical hindrances are when many developing countries have to follow some rules and procedure to procure drug for developed countries. This is not the purpose of Doha declaration which means to ease of access of medicines to all and this may be due to lack of mechanism in countries [38] . Substantial dependence on willpower of exporting country is due to manufacturing capacity to first issue compulsory license. Developed countries with good manufacturing capacity have no incentive to issue compulsory license for export. Cross Licensing A cross licensing agreement is a contract between two or more parties where each party grants rights to their intellectual property to the other parties [39] . Usually, this type of agreement happens between two parties in order to avoid litigation or to settle an infringement argument [40] . The term cross licensing implies that neither party pays financial royalties to the other party. Parties that enter into cross licensing agreements must be careful not to violate antitrust laws and regulations. One of the limitations of cross licensing is that it is ineffective against patent holding companies. The primary business Pharma Bio World
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of a patent holding company is to license patents in exchange for a financial royalty. Thus, they have no need for rights to practice other companies’ patents. Other non patent intellectual property such as copyright and trademark can also be crosslicensed. For example, a literary work and an anthology that includes that mythical work may be cross licensed between two publishers. A cross license for computer software may involve a grouping of patent, copyright, and trademark licensing. Defensive Patent License The Defensive Patent License (DPL) is a patent license planned by Jason Schultz and Jennifer Urban, directors of the Samuelson Law, Technology & Public Policy Clinic at the University of California, and Berkeley as a patent licensing equivalent of the GPL (general public license) copyright license. It requires units licensing their patents under the DPL to license all of their patents under the DPL with free licenses approved to all other DPL members. [41-44] Reasonable and Non-discriminatory Terms (RAND) Reasonable and non-discriminatory terms (RAND), also recognized as fair, reasonable, and non-discriminatory terms (FRAND) are a licensing commitment that is often required by standards establishments for members that participate in the standardsetting procedure [45] . Standard-setting establishments are the groups that set common standards for a specific industry in order to ensure compatibility of devices manufactured by different firms. RAND license are better for initial licensees or for licensees who sign a license within the first year of its accessibility. Field of Use Limitation A field of use limitation is a endowment in a patent license that confines the scope of the patent owner approves a manufacturing licensee i.e., a licensee that produces a patented product or 48 December 2014
accomplishes a patented process to do in relative to the patent, by requiring a definite field of allowable process by the licensee with assent specifying the field of use, the license may negatively state a field or fields, by stating fields of use, it would require patent infringement. This type of license permits the licensee to use the patented invention in some use in some possible ways in which the invention could be misused. In an exclusive field of use license the licensee is the only person to use the invention in the field of the license is lawful. Field-of-use limitations in patent licenses may rear antitrust issues when such arrangements are used to assign markets or generate alliances. Conclusion The weakness of patenting drug products was misuse of patient information so to prevent the misuse of drug patents compulsory license is used. Compulsory license is of great concern in treatment of life threatening diseases in developing nations. Compulsory license are granted when there is detailed clarification, and conditions to approve it. Consideration such as remunerations and socio- economic values are also taken in account while granting compulsory license and if the case is of national emergency it is granted for specific time. Compulsory licenses are simplified by adopting it under national legislation and harmonized guidelines. References 1) R o s e n D ; “ B a l a n c i n g B u s i n e s s & National Health: The Impact of Legislation on Pharmaceutical Drug Prices”; Temple Journal of Science Technology & Environmental Law, XXVI, pp. 341-363; ( 2007). 2) C h o u d h a r y D . N ; “ E v o l u t i o n o f Patent Laws in developing countries perspective”; Capital Law House; (2006). 3) W I P O ; “ G u i d e o n t h e l i c e n s i n g o f copyright and related rights” (897 of WIPO publication); World Intellectual
Property Organization; p. 16. ISBN 97892-805-1271-7; (2004). 4) Gervais, Daniel; “Collective management of copyright and related rights”; (Ed. 2). Wolters Kluwer. p. 43. ISBN 978-90-4112724-2. (2010). 5) Copinger & Skone James; “Copyright”; Volume 1, Pg.1589. 6) h t t p : / / w w w . n o l o . c o m / l e g a l encyclopedia/copyright-compulsorylicense.html. (Accessed on 20/09/2014). 7) Ford, Sara M; “Compulsory Licensing Provisions under the TRIPs Agreement: Balancing Pills and Patents;” American University International Law Review 15, no. 4 941-974; (2000). 8) Correa, Carlos; “Intellectual property rights, the WTO and developing countries, The TRIPS Agreement and Policy Options”; ZED-TWN, London; (1999, forthcoming). 9) Halewood, Michael; “Regulating patent holders: local working requirements and compulsory licenses at international law”; Osgoode Law Journal, 35 (2) 245286. (1997). 10)Stephen a. Bent et al.; “Intellectual property rights in biotechnology worldwide”; 400-01 pp. 24. (1987). 11 ) E U R - L e x L 1 5 7 Vo l u m e 4 9 p . 1 : Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. ( 9 June 2006). 12)http://www.wto.org/english/thewto_e/ minist_e/min01_e/mindecl_trips_e.htm. 13)WIPO; “What Is Intellectual Property”; World Intellectual Property Organization, Print 5; (2012). 14)Midha S, Midha A; “Compulsory license: Its impact on innovation in Pharmaceutical Sector”; International Journal of Application or Innovation in Engineering & Management (IJAIEM); Volume 2, Issue 6, ISSN 2319 – 4847; (June 2013). 15)Controller General of Patents, Designs and Trademarks, “Manual of Patent Practice and Procedure”; Patent office India ;( 2005). Pharma Bio World
16)Miller, M E; and David S. A; “DOJ, FTC Redefine Antitrust Rules on Patent Pools.” National Law Journal; 3(29 Oct. 2007). 17)Reichman, Jerome H; “Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating t h e O p t i o n s ” ; T h e J o u r n a l o f L a w, Medicine, and Ethics 37(2): 247–263. (2009). 18)Correa CM; “Center for Interdisciplinary Studies of Industrial Property and Economics (CEIDIE)”; Law Faculty, University of Buenos Aires, Argentina, Ch. 3.10. 19)Love J;“Remuneration Guidelines for Non-Voluntary Use of a Patent o n M e d i c a l Te c h n o l o g i e s ” ; W o r l d Health Organization: Geneva. (WHO/ TCM/2005.1), p 83–85. (2005). 20)Correa CM; “Compulsory Licensing: How to Gain Access to Patented Technology. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices” (Eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis; (2007). 21)Saha S; “Patent law and TRIPS: compulsory licensing of patents and pharmaceuticals”; Journal of the patent a n d t r a d e m a r k o ff i c e s o c i e t y, 9 1 , pp.364-373; (2009). 22)Novogrodsky N; “compulsory licensing in Ghana- The continuing barriers to affordable medicine”; Consumer project on technology, (9 November 2006) http:// www.cptech-on-compulsory.html. 23)Form 18 is part of Schedule II of the Patent Rules 2003. These rules came into force on 20 May 2002. 24)Section 79 of the Patents Act 1970. 25)Ulian-Arnold G;“International compulsory licensing: The rationales and the reality, Idea”;Journal of law and technology; 33(2) 349; (1993). 26)Weissman R, Along; strange “TRIPS: The pharmaceutical industry drive to harmonize global intellectual property rules, and remaining WTO legal alternatives available to third world countries”; University of Pennsylvania Pharma Bio World
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Journal of international law, 25 (3) 11161130;(2004) . 27)Reichman J.H; “Universal Minimum Standards of Intellectual Property Protection under the TRIPS Component of the WTO Agreement”; 29 INT ‘L L. 345, 351-58 (identifying Articles 30 and 31 as limitations to a patentee’s exclusive rights); (1995). 28)Gupta R; “compulsory licensing under TRIPS: How far it addresses public health concerns in developing nations”; Journal of intellectual property rights, vol 15, pp. 357-363; (September 2010). 29)Gitter D M; “International conflicts over patenting human DNA sequences in United States and the European Union: An argument for Compulsory licensing and a fair use exception”; New York university law review, 76 (6) 1690; (2001). 30.Dimwoodie G B, Dreyfuss R C; “International Intellectual Property Law and the Public Domain of Science7”; Journal of Int ‘L Econ. L. 431, 437 ;( 2004). 31.Cotropia C A;”After-Arising Technologies and Tailoring Patent Scope”; 61 N.Y.U. Ann. Surv. Am. L. 151, 168-171 (2005); Mark A. Lemley, Ex Ante versus Ex Post Justifications for Intellectual Property, 71 U. Chi. L. Rev. 129, 129-30; (2004). 32)Leaffer M; “Paris Convention for the Protection of Industrial Property”; July 14, 1967, reprinted in international treaties on intellectual property 17 ;( Ed 1999). 33)WIPO; “Summary of the Paris Convention for the Protection of Industrial Property.”;World intellectual property organization, website http. //www.wipoint/ treaties/en/ip/paris/ summary paris.html; (1883). 34)WIPO; “WIPO-Administered Treaties: Contracting Parties.”; World Intellectual Property organization, website http. // www.wipoint/treaties/en/showresults. jsp?Treatyid=2. (Accessed on 25/09/2014). 35)Correa, Carlos M; “Intellectual Property Rights and the trade related agenda
d e v e l o p m e n t a n d e q u i t y ” ; 11 , 1 2 ; (1999). 36)Attaran A;“Assessing and answering paragraph 6 of Doha declaration on TRIPS agreement and public health: the case for better flexibility and non justicaliability solution”;Emory international law review, 17 (2) 743 ;( 2003). 37)Brown, Allison “Companies Rise Intellectual Property Protection Issues”; National Defense Magazine, National Defense Industrial Association; (July 2010). 38)Reichman, Jerome H;”Compulsory licensing of patented pharmaceutical inventions: evaluating the options”. Journal of Law and Medical Ethics; 37 (2): 247–263. doi:10.1111/j.1748720X.2009.00369; (Summer 2009). 39)Shapiro, Carl; “Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard Setting”; Innovation Policy and the Economy, MIT Press, p119 et seq; (2001). 40)Jeffery F, Hewlett-Packard Company; “Patent Pools and Cross Licensing”; p8 ;( 2002). 41)Bort J; “The Defensive Patent License makes patents less evil for open source”; Network World. (07/05/2010). 42)Mueller F; “Will the Defensive Patent License be able to make patents ‘less evil’ for Free and Open Source Software?”; FOSS Patents; (May 17, 2010). 43)Schultz and Urban; “A Defensive Patent License Proposal”. Stanford Center for Internet and Society/YouTube; (May 10, 2011). 44)Brodkin J;”Defensive Patent License created to protect innovators from trolls”; Ars Technical (June 12, 2012). 4 5 ) L a y n e F, A n n e ; P a d i l l a , J o r g e A ; Schmalensee, Richard; “Pricing Patents for Licensing in Standard-Setting Organizations: Making Sense of FRAND Commitments”; Antitrust L.J. 74: 671; (2007). Contact: vivekdave1984@googlemail.com December 2014 51
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Demand, Supply Mismatch and Impediments to International Marketing – A Challenge to Indian Phytopharma Industry Though India has a rich heritage of numerous phytomedicines, export of herbal extracts from India is still at nascent stage. In this article, the author briefly address the impediments for Indian phytopharma industry.
Majeti Narasimha Vara Prasad Department of Plant Science University of Hyderabad, Hydrabad 52 December 2014
Demand, supply mismatch.indd 52
P
hytomedicine discovery and phytopharma industries are ever green fields of scientific and research domains in India. India had a history of healing plants for several thousands of years. However, the dividends earned from Indian phytopharma industries are much less compared to recent information technology. Some of the approaches for modern drug discovery are: Ethnopharmacology. Serendipity and Synthetic dominance, Chemical biology, G e n o m i c s , R e v e r s e p h a r m a c o l o g y, Systems biology and personalized approach. Plant wealth is the foundation of modern drugs. For eg; Morphine from opium poppy, Quinine from Cinchona tree, Cocaine from Coca tree, Tubocurarine from Tube curare, Pilocarpine from Jaborandi tree, Bromelain from Pineapple Hyoscine, Digoxin, Cholchicine, Emetine etc. Though Indian traditional medicine had a long history of several centuries (Hemadri 1994, Parotta 2001), India’s market share in international market is very low. (Figure 1) (Ernst 2000, 2002). The visible product sold internationally in abundance is Tea (Darjeeling and Assam). Other phytomedicinal products must meet the standards of international pharmacopeia. Considering homeland, the demand is high in case of aromatic plants and supply is rather low (Figure 2). Hunger and Malnutrition (HUNGAMA) are being publicized in media and the erstwhile Prime Minister Manmohan Singh remarked it as a “national shame”. In a study conducted in 2012 revealed that about 42 per cent of children in India under the age of five are underweight and malnourished. Therefore, nutritional security is of paramount importance and biofortification of food stuff is is the major area of research and development (Prasad and Nirupa 2007, Prasad 2008).
Several of the trace elements serve as essential nutrients and are the constituents of bimolecular as cofactors for various enzymes and in a variety of metabolic functions. Certain trace elements accumulated in medicinal plants have the healing function to some ailments and disorders for eg; zinc - neurochemical transmission; Cr and Mn can be correlated with therapeutic properties against diabetic and cardio-vascular diseases (Prasad 2008). Certain transition group elements regulate hepatic synthesis of cholesterol (Table 1). Nutrinogenomics and pharmacogenomics, medical geology (geomedical science), metallomics are the contemporary emerging areas. Very a few institutions conducting R&D in this field. 21st Century Medicinal Plants in Demand Echinacea purpurea- Immunostimulant; Panax ginseng - High cholesterol, diabetes, gastroinsestinal disorders; Serenoa repens – Benign prostatic hyperplasia, inflammations, Ginkgo biloba – dementia, mental fatigue; Hypericum perforatum – depression, epilepsy; Valeriana officinalis – hypertension; Hydrastis canadensis – gastrointestinal infections and constipation; Silybum marianum – liver disorders and lactation problems; Ephedra sinica – obesity and asthma etc. Popular medicinal plants in Indian system of medicine as per the data base of national medicinal plants board, are the following: Swertia chirata Buch-Ham (Chirata.) Anti- inflammatory, antipyretic, sudorific, antiperodic, dyspepsia,blood purifier, etc. Pharma Bio World
23-12-2014 15:09:21
Picrorhiza kurroa Benth ex Royle (Kutki) Acrid, cooling, laxative, carminative, digestive, stomachic, hepatitis, jaundice, flatulence, antipyretic, galactopurifier etc. Solanum nigrum Linn. (Black nightshade)Acrid, emollient, antiseptic, hepatomegaly, dropsy, general debility, digestive, laxative, cardiotonic etc. Saussurea costus C. B. Clarke (Costus) Acrid, Thermogenic, aromatic, cronic and foul ulcers, cough, asthama, hiccough, carminative, digestive, stimulant, etc.
Figure 1: Contemporary phytomedicines in demand are for metabolic stimulation, moderation, treatment for chronic alcoholism, circulatory diseases, benign prostrate hypertrophy
Winter cherry (Withania somnifera (Linn.) Dunal (Ashwagandha) Tonic, stimulant, aphrodisiac, thermogenic, acrid, somniferous etc. Berberis aristata DC. Indian Barberry Stomachic, tonic, diarrhoea, dysentery, jaundice, useful in eye diseases, toothaches, etc Tinospora cordifolia Miers (Gulancha.) Astringent, dyspepsia, abdominal pain, gout, jaundice, general delibity, anitspsmodic, antipyretic etc. Nardostachys jatamansi DC (Jatamansi.) Astringent, cooling, aromatic, antiseptic, digestive, carminative, epilepsy, hysteria, erysipelas, liver stimulant, etc. Gymnema sylverstre R. Br (Gudmar.) Astringent, antidiabetic, antiinflammatory, liver tonic, stimulant, antipyretic, uterine tonic etc. Plantago ovata Forsk (Isabgol.) Mucilaginous, astringent, laxative, refrigerant, emollient, anti-dysenteric, constipation, diarrhoea, gastritis, duodenal ulcers etc. Gloriosa superba L (Kalihari.) Anti inflammatory, stomachic, purgative, Pharma Bio World
Demand, supply mismatch.indd 53
Glycyrrhiza glabra L (Liquorice.) Refrigerant, emetic, tonic, diruetic, gastritis, bastric ulcers, cough, stomatitis, aphrodisiac expectorant, intellect promoting etc.
emetic, antipyretic, rejuvenating, tonic etc.
Coleus barbatus Benth. (Coleus) Diruetic, renal and urinary bladder calculi, diarrohea etc.
A n d r o g r a p h i s p a n i c u l a t a Wa l l . e x Nees) (Kalmegh) Laxative, cooling, jaundiace, dyspepsia, skin diseases, hyperdipsia, antipyretic, antiperiodic, anti-flammatory, expectorant, sudorific, digestive etc.
Piper longum L.( Long pepper ) Thermogenic, tonic, diuretic, purgative, expectorant, anorexia, spleenomegaly, aphrodiasic, fever, general debility, digestive etc.
Garcinia indica Chois (Kokum.) A s t r i n g e n t , d i a r r h o e a , d y s e n t r y, digestive etc.
Rauwolfia serpentina Benth. ex Kurz (Sarpgandha) Hypertension, acrid, l a x a t i v e , a n t h e l m i n t i c , a p p e t i z e r, sedative etc.
Element
Symptoms or disease to deficiency
Selenium
Keshena (China), bone, arthritis, cardio vascular and Cancer,
Zinc
Dwarf ness (Iran & Egypt) infertility, impaired taste and smell
Copper
Anemia, skeletal defects
Chromium
Glucose metabolism, kidney function, cholesterol disorders
Iodine
Goiter
Fluorine
Dental caries
Magnesium
Depression, nervous system
Molybdenum
Mouth/esophageal cancer
Cobolt
Anaemia
Iron
Anaemia
Sodium
Coma
Table 1: Nutritional security for combating the diseases/symptoms. Biofortified food production and advanced industry in this direction is the need of the hour.
December 2014ď‚„ 53
23-12-2014 15:11:45
antiviral, anitfertility anti-obesity, antirheumatic etc.
Adaptogen Emblica officinalis, Ocimum sanctum Tinospora cordifolia, Withania somnifera
Antimalarial Artemisia annua Cinchona officinalis
Anticancer Catharanthus roseus
Antihypertensive Rauvolfia serpentina
Antidiabetic Gymnema sylvestre, Pterocarpus marsupium
Antiinflammatory Curcuma longa, Sida cordifolia
Antidiarrhoeal Aegle marmelos, Plantago ovata
Antiulcer Glycyrrhiza glabra
Bioavailability enhancer Piper nigrum, Bacopa monnieri Centella asiatica
Anticancer Catharanthus roseus
Antiasthmatic Albizzia lebbeck
Anticancer Catharanthus roseus
Carminative stomachic Cassia senna, Cinnamomum zeylanicum Coriandrum sativum, Elettaria cardamomum Eugenia cariophyllata,Foeniculum vulgare Myristica fragrance, Zingiber officinale
Antiurolithiatic Crataeva nurvala Bergenia ligulata Tribulus terrestris
Spasmolytoc Datura stramonium, Mentha piperita
Astringent, emetic Achyranthus aspera
Tranquilizer Celastrus paniculata
Hepatoprotective Andrographis paniculata, Boerhavia diffusa Eclipta alba, Phyllanthus amarus
Table 2: Globally recognized herbal material. Quality, demand and supply chain are the impediments for phytopharma industries (Lavu et al 2013).
Cassia angustifolia Vahl.) (Senna) Purgative, jaundice, depurative, liver tonic, anthelmintic, expectorant etc. Asparagus racemosus Willd.) (Shatavari) Lactogenic, aphrodisiac,
nervine tonic, cooling, rejuvenating, carminative, appetizer etc. Commpihora wightii (arn.) Guggal Antibacterial, paralysis, rheumatoid a r t h r i t i s , g o u t , a n t i - i n f l a m m a t o r y,
Figure 2. a) Tinospora cardifolia immature fruits b) mature furits c) Celastrus paniculatus – woody climber d) C. paniculatus seeds d) cluster of Imature fruits in cluster f) Withania somnifera (Indian gensing g) Centella asiatica h) Decalepis hamiltonii j) Gymnema sylvestre k) Mucuna puriensis (inset enlarged flowers)
54 December 2014
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Marketable products in international market are scanty on the above. Impediments to the prosperity of phytopharma industries • Decline in species richness of healing plants, • lack of scientific knowledge about healing plants • deletion of plant taxonomy and field botany in educational curriculum, • lack of agro-technology for rare healing plants resources • insufficient tools for preservation and implementation of traditional knowledge • very little or no financial support for basic and classical botany as compared to so called –omics and high tech sciences. References E r n s t E ( 2 0 0 2 ) To x i c h e a v y m e t a l s and undeclared drugs in Asian herbal medicines. Trends in Pharmacological Sciences 23, 36-139
Figure 3. Popular phytomedicines available over the counter in Europe are a) Rosa fruit crystals, b) Sylybium c) Echinacea purpurea, d) Panax Ginseng, e) Aloe vera f) Ginkgo biloba g) Chlorella h) Spirulina i) Cholesterol killers j) zinc fortified nutraceutical k) bone healers l) Stress relief (Lactium) m) Aromatherapeutics n) Selenium and vitamin tonics and o) multi minerals
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Figure 6: Impediments to phytopharma industries
Planta Medica 79 (12), 1081-1083.
Figure 4: a) Bacopa monneri – mind tonic b-d) Opuntia sp. for fat removal fasciculare (male flower spathe) for aromapathy
e-g) Pandanus
Parrotta, J.A., (2001). Healing plants of peninsular India, CABI publishing, New York, USA Prasad M.N.V. (2008) Biofortification: nutritional security and relevance to human health, In. M.N.V. Prasad (ed) Trace elements as contaminants and nutrients: consequences in ecosystems and human health. John Wiley and Sons Inc. New York. pp. 161-182 Prasad, M.N.V and Nirupa N (2007) Phytoferritins - implications for human health and nutrition. The Asian and Australasian J. of Plant Science and Biotechnology 1, 1-9
Figure 5: Plants with healing properties are the raw material for phytopharma industries
Ernst E (2000) Herb-drug interactions: potentially important but woefully under researched. European Journal of Clinical Pharmacology 56, 523–524. Hemadri K (1994). Tribal pharmacopoeia (Shastravettalanu akarshistunna girijana Pharma Bio World
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vaidyam). Tribal cultural research and training institute. Hyderabad. Lavu RVS, Prasad M.N.V, Pratti VL, Meißner R, Rinklebe, Wiele TVD, Tack F, Du Laing G (2013) Metals ccumulation in Bacopa monnieri and their Bioaccessibiliy.
Prasad, M.N.V Padmalatha K, Jayaram K , R a j u N . L a n d Te i x e i r a d a S i l v a J (2007) Medicinal plants from deccan ecoregion, India - traditional knowledge ethnopharmacology, cultivation, utilization, biotechnology and conservation. Medicinal and Aromatic Plant Science and Biotechnology 1, 155-208
Contact: prasad.heavymetal@gmail.com
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marketing initiative
Three Steps to Perfection - seeking flexibility, staying in compliance
T
he only market reality that can be predicted is change – it is probably changing as you read this. To stay ahead of competition, new capital investment decisions must be able to warrant flexible manufacturing while maintaining the right level of compliance. Moreover, sites must be operationally agile to capitalise on the small windows of opportunity to install the change.
Your challenges? • • •
•
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How can NNE Pharmaplan support you? • •
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Strategic decision-making support - in house v/s outsource or a third option Compliance consulting for flexible manufacturing, regulatory requirements and how to live up to them. Manufacturing cost of goods analysis (COG) and CAPEX option analysis Risk assessments that improve operator safety, manufacturing process and quality understanding. Consulting on alternate technologies to increase flexibility and/or facility suitability Well-thought technology transfer strategies accounting all stakeholders Mock inspections to support inspection preparedness
• Should you outsource, keep production in-house or partner? How can you plan, design and build • for flexible manufacturing? What business case can justify • CAPEX for a new manufacturing facility? And how do you evaluate the corresponding OPEX? Laser-sharp focus How do good designs coupled with good working practices ensure Our exclusive focus on the biotech and operator safety? (e.g OEL/OEB, pharmaceutical industries has enabled biohazards) us to understand and provide solutions What options are available to that are specially developed to fulfil optimise your production? your needs. Can commercialisation timelines be accelerated? Our specialist knowledge combined with How can you be prepared for facility many years of hands-on experience from inspections? the industry is a unique combination.
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Meet our expert Aeby Thomas has consulted widely for vaccines and biotech companies around the world. His approach is to simplify design processes when faced with complex technology and investment options. Aeby Thomas has worked in the biopharmaceutical industry for the past 12 years. His portfolio includes assignments for leading customers in Europe and emerging markets (China, India, Brazil, Korea and Taiwan). Since joining NNE Pharmaplan in 2007 as part of the vaccine and biotech design group, Aeby Thomas has led several assignments globally; his engagements have included special task force for process improvements, feasibility for new investments, conceptual designs and engineering consultany. Today, Aeby Thomas also heads the consulting group at NNE Pharmaplan in India. Contact Jaya Jha Sales & Business Development +91 70 4229 4079 jxjh@nnepharmaplan.com www.nnepharmaplan.com Pharma Bio World
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press release A s h l a n d L a u n c h e s W e b - b a s e d 60P Australia Partners with Monash Film-coatings Troubleshooting Tool University Formulators are looking for swift, tailored solutions to identify the best film coating for their dosage forms and to better respond to film-coating issues when they arise. To meet this need, Ashland Specialty Ingredients, a commercial unit of Ashland Inc, recently launched a web-based film-coatings troubleshooting tool to enable formulators to quickly solve their toughest tablet-coating challenges. Ashland’s line of fully formulated, easily dispersed and ready-touse Aquarius film coating systems have a range of functions to suit almost any core. With a wide selection of film-coating choices, Ashland provides optimal coatings for unique formulations. Functional coating capabilities including moisture barrier, odor- and taste- masking, and controlled/delayed release from Ashland are based on acrylate polymers or combinations of cellulosic and other polymers and unique ingredients to offer the desired functionality. Ashland, a manufacturer and marketer of pharmaceuticalgrade cellulose-derived and vinyl pyrrolidone-based polymeric excipients, has concurrently unveiled a completely refreshed pharmaceutical website.
Monash University and 60P Australia Pty Ltd (60P), a subsidiary of 60° Pharmaceuticals LLC, have announced an exclusive partnering deal, with 60P obtaining rights to develop the drug Fenretinide for dengue fever. More than one third of the world’s population is at risk of dengue, a tropical disease caused by the transmission of dengue virus by several species of mosquito. From an estimated 96 million symptomatic infections each year, there are approximately 500,000 hospitalisations for the severe form of the disease (dengue haemorrhagic fever) with around 12,500 deaths. Current treatment for dengue fever consists of either oral or intravenous rehydration for mild or moderate cases, and intravenous fluids and blood transfusion for more severe cases. The economic burden of clinical cases has been estimated at USD 12 billion per annum. Monash University researchers, led by Professor David Jans in the Department of Biochemistry, have developed a novel screening approach for identifying new classes of antiviral drugs.
BioAsia’15 to Address ‘New Bionova Foresee 300% Revenue Opportunities in the Transition’ In line with promise of India’s reform program in various Growth by FY 2017 Bangalore based application research and formulation company, Bionova has announced that the company is betting on the rapid development of Indian biopharma industry and foresee 300 per cent revenue growth by end of financial year 2017. The company is planning to launch a range of OTC products for infant nutrition, child growth, diabetic supplements and wellness. The new range of product line will enable Bionova to develop a competitive stand along the line of present Indian and global players in the market. Increasing awareness on alternative wellness products, growing confidence in OTC products, and change of prescription drugs to OTC products will drive the pharmaceutical market. The various segments of OTC products such as Vitamins & Minerals, Gastrointestinal, and Cough Cold & Allergy are the major reasons for the popularity of the OTC product market. Growing number of self-treatment patient base and their confidence in the OTC drugs is helping the Indian market to grow. Bionova has invested towards formulation and research activities across it OTC product range to acquire market pie in the branded formulations space. Pharma Bio World
sectors, the 12 th edition of the annual international Lifesciences conference, BioAsia 2015 will unveil the ‘New Opportunities in the Transition’ in the field of life sciences & health care industry. BioAsia 2015 will be held in Hyderabad from February 2 to 4, 2015. The various editions of BioAsia have been acting as a catalyst towards bringing attention to the industry in India and its potential, adding momentum to the ‘Make In India’ focus of the government of India. The Indian biotechnology sector is one of the fastest growing knowledge based sectors in India and holds high promise in shaping India’s rapidly developing economy, given the global transformation and need for more affordable medicines.
With cost containment measures and moves to cut health expenditures by Governments across continents, the pressure on global drug industry to reap more from less is palpable. As one step typically seen, the industry has more than embraced partnerships, eased out of non-core and grown into specialized segments. December 2014 57
press release Cadila Pharmaceuticals Organises IAMICON 2014 Cadila Pharmaceuticals Limited – one of India’s largest privatelyheld pharmaceuticals companies – organised IAMICON 2014 (Indravadan Ambalal Modi Innovation Conclave), India’s biggest scientific conclave for celebrating Innovation and Excellence in the Pharmaceuticals and Life Sciences sector. Covering 50 cities across India, IAMICON 2014 focused on advances in the treatment of Tuberculosis and Cardiovascular diseases. Cadila Pharmaceuticals is also committed to Government of India’s ‘TB-Mission 2020’, which seeks to eliminate Tuberculosis from the country. Conceived to celebrate Innovation and Excellence in the Pharmaceuticals and Life Sciences sector, IAMICON brought together the world’s brightest minds in Medical Science and discussed and disseminated the latest updates in Science and Medicine.
Merck Supports WHO to Fight Schistosomiasis in Africa Merck has announced that Ethiopia will receive around 13 million praziquantel tablets in 2015. Merck supports the World Health Organization (WHO) to fight the parasitic worm disease schistosomiasis in Africa. Praziquantel is the most effective treatment for schistosomiasis. According to WHO, Ethiopia is one of the most endemic countries for schistosomiasis in the world. It is estimated that around 22 million people, which is more than 20 per cent of the entire population, requires treatment. Since the start of the programme around 1.4 million patients, primarily children, have been treated. “We will donate 100 million praziquantel tablets to African countries in 2015. Ethiopia will be one of the main beneficiaries of this donation”, said Frank Gotthardt, Head of Public Affairs at Merck and responsible for the Merck Praziquantel Donation Programme.
Bosch, Klenzaids Plan Joint Venture in India Processing and packaging specialist Bosch Packaging Technology and Klenzaids Contamination Controls Pvt Ltd are planning a joint venture in India. Both companies signed agreements to this effect on November 28, 2014. The plan is for Bosch to acquire a 49 per cent share in Klenzaids, an owner-managed company that produces processing, packaging, and clean-room technology for the global pharmaceutical industry. 58 December 2014
By setting up the joint venture, the two partners aim to extend their global reach, particularly in liquid pharmaceuticals and packaging machines for clean-room environments. The Klenzaids and Bosch Packaging Technology product portfolios complement each other across the board. In particular, the joint venture will allow the companies to better satisfy Indian customers’ growing demand for complete lines from a single source. Based in Mumbai, Klenzaids generated sales of around six million euros in 2013 and employs some 350 people.
Ranbaxy Launches Infimab - India’s First Infliximab Biosimilar Ranbaxy Laboratories Limited has announced the launch of Infimab (BOW015), the first Remicade (Infliximab) biosimilar in India. The product was launched at the Indian Rheumatology Association Conference (IRACON), in the presence of over a thousand rheumatologists and doctors from around the country. Infimab, is being introduced to the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialisation of biosimilar monoclonal antibodies. Infimab will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis (RA), Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.
No Poof that Fluad Caused Death: PRAC The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no evidence that Fluad, a flu vaccine manufactured by Novartis, has caused serious events including deaths in Italy. These reports led the Italian Medicines Agency (AIFA) to suspend the use of two batches of Fluad as a precautionary measure on 27 November 2014. Fluad is used in older people (65 years of age and older), especially in those who have a number of illnesses at the same time and are at an increased risk of health complications. After the review of the cases reported, the PRAC concluded that there was no evidence for a causal relation between the reported fatal events and the administration of Fluad. Fluad is authorised in the European Union (EU) in a number of Member States. For the current vaccination campaign in Italy, about 4 million doses of Fluad have been distributed. The vaccine has also been used for the 2014/15 flu vaccination campaigns in Austria, Germany and Spain. Pharma Bio World
press release Jubilant Wins Excellence Awards at ‘India Pharma Awards 2014 Jubilant Life Sciences has been conferred with this year’s two prestigious CPhI India Pharma Awards in Excellence in Corporate Social Responsibility and Excellence in Environment, Health & Safety (EHS) at an awards ceremony here. The CPhI India Pharma Awards recognizes and rewards selected path-breaking initiatives undertaken by the Indian Pharmaceutical industry around key areas of quality, product design, cost management, packaging and environmental health & safety. Jubilant was chosen for Excellence in Corporate Social Responsibility for its exemplary workthrough outreach activities that has resulted in betterment of the wider community and environmental sustainability. Jubilant through its non-profit wing, Jubilant Bhartia Foundation (JBF), has been engaged in empowering communities with initiatives that focus on primary education, basic healthcare and skill development for employability and self-sustenance. The second award for Excellence in Environment, Health & Safety (EHS), was conferred to Jubilant for its initiatives in improving EHS standards and compliance with a positive impact on company’s profitability, external stakeholders and society at large. The award recognises Jubilant’s outstanding achievements in ensuring better regulatory compliance, reduced resource (eg, water/ energy, RM) consumption & cost of production, reduced ecological footprint (emission/ effluent/ hazardous waste), and reduced Carbon footprint amongst many others.
SPARC Gets CRL from US FDA for Latanoprost NDA HRS Process Systems Ltd (HRS), part of HRS Group, UK recently participated in the 6 th annual Pharma Machinery, Equipment & Technology (P-MEC) India expo held from 2 nd to 4 th December, 2014 at Bombay Exhibition Center, Mumbai. The company displayed specialised, high performance heat transfer solutions such as ECOFLUX Corrugated Tube Heat Exchangers, HRS Funke Plate Heat Exchangers and HRS Hot Water Systems. One of the leading heat exchanger specialists catering to the Pharmaceutical industry, HRS operates at the forefront of thermal processing technology. The company is known for offering energy efficient and hygienic solutions for an extensive range of applications. HRS’ clients such as Cipla, Cadila, Dr Reddy’s, Laurus, Mylan, Ranbaxy, Sun Pharma and many more reputed pharma companies visited this event. Pharma Bio World
The Indian pharmaceutical industry has expanded significantly in the last two decades. India is now among the top five emerging pharmaceutical markets. The domestic pharma market is estimated to touch USD 20 billion by 2015, making India a lucrative destination for global giants. The healthcare market in India is estimated to reach USD 31.59 billion by 2020.
SPARC Gets CRL from US FDA for Latanoprost NDA Sun Pharma Advanced Research Company (SPARC) Ltd has announced that the US Food and Drug Administration (FDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops. While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA. SPARC believes that this additional information request from the FDA can be addressed on priority.
BÜCHI Expands its Worldwide Presence BÜCHI Labortechnik AG, a leading supplier in key technologies for laboratory equipment, expands its worldwide presence with the opening of the new offices in Singapore in September and Malaysia in November 2014. Southeast Asia has continued to experience steady growth over the past few years, for example in the area of nutritional supplements, specality chemicals or pharmaceuticals industry. “To enlarge our presence with the opening of our offices in Malaysia and Singapore is the consequence of strenghening customer- as well as partner relations in these growing markets”, Liner says.
Strides Receives FDA Approval for Calcitriol Softgel Capsules Strides Arcolab Limited has received approval from the United States Food & Drug Administration for Calcitriol Softgel Capsules, 0.25mcg and 0.5mcg. According to IMS data, the US market for generic Calcitriol Softgel Capsules is approximately USD 50 Million, with only three players having approval for both the strengths of Calcitriol. The product will be manufactured at the Company’s Oral dosage facility at Bangalore and marketed by Strides in the US Market. December 2014 59
pharma news Dr Reddy’s Launches Generic Valcyte Dr Reddy’s Laboratories has launched Valganciclovir Tablets USP 450 mg, a therapeutic equivalent generic version of Valcyte (Valganciclovir) tablets in the US market on December 15, 2014, approved by the United States Food & Drug Administration (US FDA). The Valcyte (Valganciclovir) tablets brand had US sales of approximately USD 440 Million MAT for the most recent twelve months ending in October 2014 according to IMS Health. Dr Reddy’s Valganciclovir tablets, USP in 450 mg is available in bottle counts of 60.
With the recent addition of the third cleanroom, filling of singlechamber syringes is now available with a maximum filling speed of 3,600 units per hour, and batch sizes as large as 25,000 units. The line is constructed as a Restricted Access Barrier System (RABS), offering various filling pumps depending upon products unique characteristics, as well as fully automated tub processing. The two existing cleanrooms, both operational since late 2011, provide fully automated vial filling for batches up to 10,000 liquid or lyophilized vials, as well as semi-automated filling for manufacturing prefilled syringes, cartridges, and vials in small batch sizes of a few hundred.
Alexion to Buyback Shares Worth Mylan Launches Generic Robaxin $ 500 Mln Mylan Inc has announced the US launch of its Methocarbamol Alexion Pharmaceuticals, Inc announced that the Company’s Board of Directors has authorised a new share repurchase programme of up to USD 500 million. The new share repurchase programme will take effect upon completion of the Company’s current programme, which has approximately USD 22 million remaining of its previously authorised USD 400 million. Under the programme, purchases may be made from time to time on the open market, including through 10b5-1 trading plans, or through privately negotiated transactions, block transactions, or other techniques, as determined by the Company’s management and in accordance with prevailing market conditions and the requirements of the Securities and Exchange Commission. Alexion expects to fund all purchases from cash on hand and future cash flows from operations. The Board’s authorisation is open-ended and does not establish a timeframe for the purchases. The Company is not obligated to acquire a particular number of shares, and the programme may be discontinued at any time at the Company’s discretion.
Vetter’s Chicago Facility is Ready to Accept Clinical Syringe Projects Vetter’s US early-stage development site located at the Illinois Science + Technology Park in suburban Chicago, has completed the next step of its expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility, which can handle preclinical through phase II projects. The overall 30,000-squarefoot site offers all of the resources needed for efficient early-stage clinical manufacturing, including chemical analysis and microbiology labs, material preparation and compounding functions. At the heart of the facility is its three cleanrooms, followed by visual inspection capabilities and GMP storage. 60 December 2014
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Injection USP, 100 mg/mL, packaged in 1,000 mg/10 mL singledose vials. This product is the generic version of Hikma Maple Ltd’s Robaxin. Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Methocarbamol Injection, which is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Mylan’s immediate shipment of this product supports the growth of the company’s portfolio of more than 100 injectable products in the US. Methocarbamol Injection USP, 100 mg/mL, had US sales of approximately USD 15.1 million for the 12 months ending September 30, 2014, according to IMS Health.
Eli Lilly Receives 3 rd FDA Approval for Cyramza Eli Lilly and Company has received its third US Food and Drug Administration (FDA) approval for Cyramza (ramucirumab). Specifically, Cyramza is now also indicated in combination with docetaxel, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Cyramza. This latest approval of Cyramza was received on December 12, 2014. This approval of Cyramza (ramucirumab injection 10 mg/mL solution) marks the first FDA-approved medicine for use in combination with docetaxel in the secondline treatment of metastatic NSCLC, including nonsquamous and squamous histologies. Pharma Bio World
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biotech news TWi’s AC-201 CR Phase II Clinical Trial Protocol Gets US and Taiwan FDA Nod TWi Pharmaceuticals’ fully owned subsidiary, TWi Biotechnology Inc has received US FDA and Taiwan FDA approval of a protocol for a Phase II clinical trial of its AC-201 controlled-release (CR) tablets for the indications of high blood uric acid level and gout. The company will start to enroll patients for the Phase II clinical trial as soon as possible.AC-201 is a first-in-class, small molecule which has shown the ability to inhibit the production and activity of caspase-1 and the cytokine Interleukin-1Beta (IL-1Beta), and to down-regulate IL-1Beta receptors.
EC Grants Orphan Drug Status to TxCell’s ColTreg TxCell SA, a biotechnology company developing innovative, cost-effective, personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces that the European Commission (EC) has granted orphan drug designation to TxCell’s investigational medicinal product ColTreg, a personalized T cell immunotherapy using collagen-II specific regulatory T-cells, for the treatment of autoimmune uveitis. Autoimmune uveitis is a debilitating inflammatory condition of the eye, often resulting in permanent vision damage. Uveitis is one of the leading causes of blindness in the developed world. It is a rare disease with a prevalence of around 35-50/100,000. Autoimmune uveitis constitutes 80-90 per cent of cases. No treatment is currently approved for the patients that become refractory to corticosteroid compounds. In addition, these products are known to cause serious side effects when used for a prolonged period. Because of the low safety and the increased resistance to existing drugs, the development of new and safer class of therapeutics to treat autoimmune uveitis is essential.
OPKO, Pfizer Sign Deal to Market hGH-CTP OPKO Health, Inc, multinational biopharmaceutical and diagnostics company, and Pfizer Inc have entered into a worldwide agreement for the development and commercialisation of OPKO’s long-acting hGH-CTP for the treatment of growth hormone deficiency (GHD) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by two years of age. hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone to Pharma Bio World
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a single weekly injection from the current standard of one injection per day. hGH-CTP is currently in a global phase 3 trial in adults and a global phase 2 trial in children and has orphan drug designation in the US and Europe for both adults and children with GHD. Under the terms of the agreement, OPKO will receive an upfront payment of USD 295 million and is eligible to receive up to an additional USD 275 million upon the achievement of certain regulatory milestones. Pfizer will receive the exclusive license to commercialise hGH-CTP worldwide. In addition, OPKO is eligible to receive initial royalty payments associated with the commercialisation of hGH-CTP for Adult GHD which is subject to regulatory approval. Upon the launch of hGH-CTP for Pediatric GHD, which is subject to regulatory approval, the royalties will transition to gross profit sharing for both hGH-CTP and Pfizer’s Genotropin.
Anergis Gets US Patent for AllerR Anergis, a biopharmaceutical company developing proprietary ultra-fast allergy vaccines, has received a notice of allowance from the US patent authorities for its patent covering composition and methods of use of its ragweed allergy product AllerR. AllerR is based on Anergis´ unique Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceuticalgrade, longpeptide immunotherapeutics designed for an ultra-fast, safe and longlasting treatment of allergy patients. Ragweed pollen is believed to be the most allergenic of all pollens. Allergies to ragweed pollen are mostly prevalent in the USA, where they affect an estimated 27 million patients, with a high degree of severity in many of them. Among others, ragweed allergies are a major cause of asthma.
Vical Closes Enrollment for Vaxfectin Clinical Trial Vical Incorporated has announced the completion of enrollment in a Phase 1/2 trial of its Vaxfectin-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), the predominant cause of recurrent genital herpes. The enrollment was completed on schedule as originally planned. The randomised, double-blind, placebo-controlled trial will evaluate safety, tolerability and efficacy of two vaccine candidates (one encoding glycoprotein D alone and the other in combination with UL46). The study is powered to show at least a 30 per cent decrease in the viral shedding rate following 3 doses of vaccine. A total of 165 otherwise healthy HSV-2- infected patients aged 18 to 50 years were enrolled across seven US trial sites. The Company expects to release efficacy data by the middle of 2015 December 2014 61
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CIP/SIP Modules CIP/SIP technology offers significant advantages to manufacturing facilities from efficient cleaning of process equipment and piping at lower costs to improved product quality. CIP systems are fully integrated incorporating tanks, pumps, valves, spray cleaning devices, heat exchangers, piping and controls without the need to disassemble all or part of the system, significantly reduces cleaning costs and minimises the handling of chemicals to provide a safer environment for plant personnel.The CIP process involves sequence of cycles that includes an initial and final drain step, a pre-rinse and post-rinse step. The CIP process may include a sanitise cycle to reduce the levels of bacterial contaminants. This cycle uses aqeous solutions of strong oxidants such as hydrogen peroxide, ozone and chlorine containing compounds. For more information, please contact: Industrial Equip Wash Inc 8/B Surat Singh Indl Estate, S V Road, Jogeshwari (W) Mumbai 400 102 Tel: 022-26797941 | Fax: 91-022-26798066 E-mail: iewi@mtnl.net.in
Particle Characterisation Systems Particle characterization systems from Malvern Instruments are helping LPW Technology to provide certified powders for additive manufacturing (AM) applications in the aerospace, automotive and biomedical sectors. Particle size and shape are performance-defining parameters for AM powders. Malvern’s Mastersizer 3000 laser diffraction particle size analyzer delivers rapid, routine particle size measurement for all the powders that LPW supplies. The Morphologi G3, a microscopy-based automated image analysis system, enables quick, efficient and statistically significant measurement of particle size and shape parameters. For more information, please contact: Malvern Aimil Instruments Pvt Ltd Naimex House, BSEL Tech Park, B Wing – 906 Sector 30A Opp Vashi Railway Station, Vashi, Navi Mumbai 400 705 Tel: 022-39183596 | Fax: 91-022-39183562 E-mail: Stuart.Wakefield@malvern.com
Mass Flowmeter KROHNE, Inc offers OPTIMASS 6400, an all-new twin bent tube Coriolis mass flowmeter, ideal for standard liquid and gas applications in the chemical and petrochemical, oil and gas, pharma, food and beverage, and energy and power industries. It is equipped with a new signal converter that features advanced device and process diagnostics, compliant to NAMUR NE 107. It has been approved for custody transfers of both liquids and gases, making it ideal for process industries and specialist applications like LNG, CNG or supercritical gases in terminal or storage/bunkering, along with custody transfer applications. It is the first Coriolis mass flowmeter to feature advanced entrained gas management (EGM), with no loss of measurement with gas entrainment up to 100 per cent of volume. The OPTIMASS 6400 with EGM can follow and correct for the varying amplitudes. EGM continues to present an actual measured reading, together with an indication or configurable alarm that improves processes by identifying transient gas entrainments. Available in a range of sizes from DN 08 to 250, the OPTIMASS 6400 is offered in SS-316L, Hastelloy C22 and Duplex steel UNS S31803. Compliant to NAMUR standard installation lengths, the OPTIMASS 6400 operates in high temp up to 400°C, as well as cryogenic applications down to -200°C. It also handles pressures up to 200 bar (2900 psi). It is the first KROHNE mass flowmeter to feature the new MFC 400 signal converter. The MFC 400’s fast, completely digital signal processing enables the EGM feature and outstanding dynamic density measurement, as well as enhanced diagnostic and status indications. For more information, please contact: Krohne, Inc 7 Dearborn Rd, Peabody, MA 01960, U.S.A. Tel: (800) 356-9464, (978) 535-6060 E-mail: olley@KROHNE.com
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Portable Leak Detector CS Instruments GmbH, Germany, offers LD400 portable leak detector with 2” display and ultra-high sensitivity that reduces the expenses of compressed air systems and eliminate leakages. It is long lasting device which transforms characteristic ultrasonic signals into audible sound from distance of several meters. Sound-proof headset enables to detect leak in extremely noisy environments. LD400 has internal battery for power supply of up to 16 hours. Leakages can be detected in compressed air lines, gas, vapour and vacuum plants, refrigerating plants and door seals.
2-D Barcode Reading Cognex Corpn offers its PowerGrid technology, a texture-based location algorithm that takes a unique, insideout approach to reading 2-D matrix and Direct Part Mark (DPM) codes. While conventional feature-based algorithms start by locating the finder pattern, Cognex’s PowerGrid technology looks for a pattern of alternating light and dark modules within the code. PowerGrid technology dramatically increases read rates in 2-D barcode-reading applications where a part’s geometry, poor lighting, occlusion or print-registration errors make it difficult to capture an image of the entire code..PowerGrid technology can locate and read codes even when they exhibit significant damage to or complete elimination of the finder pattern, clocking pattern or quiet zone.
For more information, please contact:
For more information, please contact:
AV Measurement & Control (India)
Cognex Corporation One Vision Drive Natick, MA 01760-2059 U.S.A. E-mail: vaggu.sunil@cognex.com
Plot No: P46/1, 102 Sonata Comml Complex Dombivli (E), Dist: Thane, Maharashtra 421 203 Tel: 0251-2424418, 6458885 E-mail: vadnerkar@avmacindi8a.com / sheeja@avmacindia.com
Cost Calculator Mettler Toledo, Process Analytics Division offers cost calculator to compare different sodium analyzer types. Sodium contamination monitoring in high purity water is essential across a variety of applications and industries. When evaluating analyzers that meet this monitoring need, it is important to consider the annual operating cost and not just the capital cost of the instrument. With better technology, automation and the more reliable components being used today, a well-maintained analyzer is expected to last 10 years or more. This makes the annual operating cost, which accounts for the consumables and cost of labour to maintain the analyzer, very important. The consumables and labour cost will be a substantial investment over the life of the analyzer, sometimes exceeding the actual cost of the analyzer itself. The Mettler Toledo Thornton cost calculator takes all these factors into account and offers you the true annual operating cost of an analyzer in a variety of currencies. It offers comprehensive information that allows for a more informed decision on analyzer selection For more information, please contact: Mettler-Toledo Thornton, Inc 900 Middlesex Turnpike, Bldg 8, Billerico, MA 01821, U.S.A. Tel: +1 781-301-8600 Fax; +1 781-301-8701 E-mail: robyn.mellish@mt.com
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events diary
BioPharma World Expo 2015 Date: 28 th -31th January 2015 Venue: Bombay Exhibition Centre, Mumbai
BioAsia 2015 Date: 2 nd - 4 th February 2015 Venue: Novotel Hyderabad Convention Centre, Hyderabad, Telangana
BioPharma World Expo 2015 will be organised concurrently during the 27 th edition of CHEMTECH World Expo scheduled from January 28-31, 2015 at Bombay Exhibition Grounds, Goregaon (East), Mumbai. CHEMTECH has scheduled one day conference on BioPharma under the Chairmanship of Dr Harish Iyer , managing Director, Shantha Biotech on January 30, 2015. The international conference aims at bringing the icons from the pharmaceutical and allied biotech sector to deliberate and discuss the expectations of the industry towards realising the vision of Make in India of the Honourable Prime Minister and building a healthy nation. The BioPharma Expo will provide an opportunity to connect with the eminent personalities from the industry presenting cutting-edge discoveries, research and opportunities for new business practices and partnerships.
BioAsia 2015 - the twelfth edition of the widely attended annual convention, is all set to bring together the global industry leaders, researchers, policy makers, innovators, and investors together on one platform discussing the new opportunities in the transition. BioAsia 2015, as a unique meeting platform of leaders from across the industry, will offer the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India.
Contact:
Pharma Commercial and SFE Summit, MENA
Amrita Patil Tel: +91-22-4037 3617 | Mob: +91-9224404990 Fax: +91-22-4037 3635 Email: amrita_patil@jasubhai.com
Contact: Paridhi Gupta Tel: +91 40 6644 6477 / 6577 E-mail: paridhi@bioasia.in Website: www.bioasia.in
Date: 2 nd - 4 th February 2015 Venue: Dubai, United Arab Emirates
PHARMAceutical EXPO 2015 is organized by Federation of Indian Chamber of Commerce and Industry concurrent with the 66th Indian Pharmaceutical Congress scheduled to be held at Hitex Exhibition Centre, Hyderabad, Telangana from January 2325, 2015. PHARMAceutical EXPO 2015 provides an opportunity to the participating companies to display their products and services to the business visitors from across the globe.
The Pharma Commercial and SFE Summit, MENA is a platform for industry leaders to discuss how to adopt global strategies, to drive up sales efficiency through improved training and continue the evolution of closed loop marketing in the MENA region. This three day forum provides valuable insights into the MENA pharmaceutical market and reveals the latest models of sales techniques, examines the best ways to implement effective commercial strategies, teaches how to customize the sales tactics into local conditions, new innovations in Closed Loop Marketing, Key Account Management, the need to become more patient centric, provides a comparison of sales activities in MENA region versus global markets and discusses all the most pressing topics that are currently being faced.
Contact:
Contact:
PHARMAceutical EXPO 2015 Date: 23 rd - 25 th January 2015 Venue: Hitex Exhibition Centre, Hyderabad, Telangana
Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ficci.com 64 ď‚ƒDecember 2014
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Ciaran Chapman Tel: +421 221 025 322 | Fax: +421 252 444 220 E-mail: enquiry@lloydsconferences.com Website: www.pharmasfedubai.com Pharma Bio World
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bookshelf Advanced Technologies in Biopharmaceutical Processing (Hardcover) Authors: Roshni Dutton, Jeno Scharer Price: USD 102.10 No of Pages: 284 Pages About the Book: An increasing number of pharmaceuticals in human and veterinary medicine are being developed using advanced genetic and other methods that focus on modification of somatic and embryonic cells. These methods, in the setting of drug manufacture, call for new processes that go beyond the traditional unit processes of chemical and biological production, such as batch submerged culture. This book is the first to describe in detail these advanced biological processes and show how they are applied to the production of biopharmaceuticals, from product generation and purification to fill-finish operations.
Handbook of Pharmaceutical Granulation Technology, 3rd Edition (Drugs and the Pharmaceutical Sciences) (Hardcover) Author: Dilip M Parikh (Editor) Price: USD 180.45 No of Pages: 676 Pages About the Book: This book presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the reader in selecting the ideal technology for his/her company’s particular drug delivery system. This knowledge helps ensure that regulatory guidelines are followed and met in a cost-effective manner. All chapters in the Handbook of Pharmaceutical Granulation Technology explore the fundamentals of powder characterization, granulation, and state-of-the-art technologies, modeling, application of expert systems, and manufacturing optimization.
Transdermal and Intradermal Delivery of Therapeutic Agents: Application of Physical Technologies (Hardcover) Author: Ajay K Banga Price: USD 100.54 No of Pages: 309 Pages About the Book: Skin, once thought to be an impenetrable barrier, is an extremely active organ capable of interacting with its environment. Advancements in science combined with the need for diverse drug delivery modalities have introduced a variety of transdermal and intradermal products for existing drugs at a fraction of the cost of new drug development. Commercialization of transdermal drug delivery requires technology from many disciplines beyond pharmaceutical sciences, such as polymer chemistry, adhesion sciences, mass transport, web film coating, printing, and medical technology.Up-to-date and accessible to researchers and industry experts, this book provides a comprehensive discussion of the physical approaches and practical considerations for the laboratory and marketplace.
Pharma Bio World
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Pharma Bio World
Chemical Products Finder | November 2013 | 57
R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16 Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 68