PBW September 2017 by Pharma Bio World

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VOL 16 ISSUE 02 SEPTEMBER 2017 MUMBAI TOTAL PAGES 60 ` 150

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4  September 2017

Pharma Bio World

INTERVIEW 08

“Piramal Pharma Solutions has all the tools to become a global leader” - Vivek Sharma, Chief Executive Officer, Piramal Pharma Solutions FEATURES

Optimizing Unit Operations in Biopharmaceutical Manufacturing - Glenn Hiroyasu, Ravi Prasad

Advances in mAbs Technologies with Changing Business Environment - Rajesh Gupta, Gaurav Abhishek, Niharika Ruhela, Tushar Sukhdevrao Shende

Is Health a Subject Matter of Veg Vs Non Veg? - Vivek Seigell

Falsified Medicines Directive: Don’t Lose Track of Compliance - Arthur Smith

How Technology Transform the Pharmaceutical Industry in India - Sameer Bhalla MARKET RESEARCH

Time to Look at Pharma Funds - HDFC sec Inst Research CASE STUDY

HMX-Ambiator Helps Himalaya Prevent Degradation of Raw Materials - A.T.E. ENTERPRISES PRIVATE LIMITED

NEWS UPDATE 44

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Next Issue Focus: Quality Assurance

6  September 2017

Pharma Bio World

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interview

Vivek Sharma

“Piramal Pharma Solutions has all the tools to become a global leader” A subsidiary of Piramal Group, Piramal Pharma Solutions is a leading Contract Development and Manufacturing Organization (CDMO) devoted to Quality, Reliability, Innovation and Customer centricity. Using a collaborative partnership model, Pharma Solutions offers a multitude of services covering the entire drug life cycle. Vivek Sharma, Chief Executive Officer, Piramal Pharma Solutions, in an interview with Mahesh Kallayil, discusses evolving role of CDMOs in Indian Pharma Industry and much more… How has Piramal Pharma Solutions (PPS) journey been thus far? How will be the road ahead? Piramal Pharma Solutions began its operations as an Indian centric organization 2 decades ago. Today, it has transformed into a global organization with 12 R&D and manufacturing facilities- 3 in North America, 2 in Europe, and 7 in India. The breath of services that PPS provides has significantly expanded and now includesdiscovery support, drug substance and drug product development, commercial manufacturing, and clinical trial supplies. Further, its generic portfolio has also grown significantly, with PPS filing 40 DMF’s to support current and prospective clients with cost effective manufacturing of key medicines. With external partnerships now becoming an integral part of how pharmaceutical firms and biotechs do business, the future looks bright for leading Contract Development and Manufacturing Organizations (CDMO’s), as they are at an inflexion point in their growth curve. Piramal Pharma Solutions has all the tools to become a global leader- a customer centric culture, a strong focus on innovation, a robust balance sheet, a commitment towards investment, and finally, a talent pool that combines speed, with quality 8  September 2017

and delivery. As our clients seek dependable partners that can offer seamless, integrated solutions, from Discovery through Commercialization, from Drug Substance to Drug Product, we expect PPS to deliver on these needs, and build long term, sustainable and strategic partnerships. As a leader in Contract Development and Manufacturing Organisations (CDMOs), what are the services and solutions Piramal offer for the entire pharmaceutical industry? Piramal Pharma Solution’s core competency revolves around providing end-to-end solutions to clients, aiding and supporting clients in advancing their assets from discovery into clinical development, and through commercialization. For example- To an aspiring biotech with rapid and cost effective advancement, Piramal Pharma Solutions will assist in identifying the right molecule by synthesizing several molecules to screen for biological activity. Once the right molecule is identified, PPS will then develop a process to ‘scale-up’ the molecule(s) for toxicology studies and then work closely with the client to develop a formulation to deliver the molecule into Pharma Bio World

interview humans. Finally, PPS completes the early development process by manufacturing the Active Pharmaceutical Ingredients (API), and the formulated drug product to enable the filing of an Investigational New Drug (IND). Further, as the drug advances through clinical trials, PPS continues to work closely with the biotech to assist them at every stage of drug development, providing the biotech with the Active Pharmaceutical Ingredient (API), drug product, and Clinical Trial Packaging and Supplies, as needed. Several clients prefer working with us for both API and drug product, as PPS helps reduce tech transfer time, which in turn speeds up the clinical trial process. Further, we manage all elements of the partnership internally, with a single point of contact, making it easier for clients. What are the factors to be considered while choosing an outsourcing partner Several factors must be consideredAlignment of values and culture, transparency and honesty in communication, especially as one works through potential challenges in sciences. Quality, commitment towards safety, and a customer centricity culture, are also key ingredients in a successful CDMO. The CDMO’s track record, versatility in its capabilities, its geographical footprint (example: a client may want to launch a drug in North America or Europe, while still deriving the costs benefits from Asia), and the flexibility in meeting timelines, are areas to evaluate in a potential partner. Finally, clients need to make sure that the project will get the time and attention it deserves: Clients should be wary of working with CDMO’s that assign substandard teams towards programs that are not their largest revenue generators. 10  September 2017

What are the main differences between CDMO, CRO and Functional Service Provider (FSP)? • C R O ’ s : C o n t r a c t R e s e a r c h Organizations; They work principally from Discovery through Early Development (Discovery, Phase I) • CDMO’s: Contract Development and Manufacturing Organizations; They principally work from Phase I through commercialization • FSP, Functional Service Providers: Have deep knowledge across particular verticals (ADME, Computational C h e m i s t r y, P r o t e i n C l o n i n g a n d Expression etc. Please brief us on offshoring in pharmaceuticals? Certain clients prefer to have their own locations in cost effective geographies, instead of outsourcing it to third parties. For example, a large pharmaceutical company may decide to have their own employees to conduct discovery research in India or China to have ‘control’ on the process, while still deriving cost benefits. Currently what are the major challenges for contract manufacturing? Good CDMO’s have a challenge in obtaining capacity to meet growing client needs. In areas such as injectable manufacturing, it is difficult for clients to obtain capacity available for periods up to 12 months. On the flip side, there have been some challenges in Asia, with quality issues at certain firms being highlighted as a cause of concern. In a regulated industry, Quality concerns lead to significant client erosion. How is the company positioned in the Indian and global market in the field of contract manufacturing? We a r e w e l l p o s i t i o n e d w i t h m u l t i p l e locations in the West and in Asia. This

allows us to be close to the clients that are interested in local launches while still integrating the supply chain by leveraging our locations in Asia. With excellent manufacturing and development locations, and a clean track record on quality, clients trust us with some of their most valuable assets. We have launched 35 products for clients (including multi-billion dollar drugs such as Ninlaro, and Velcade), and expect to launch 10 more this year, and have a pipeline of around 90 products in Phase II/III. How does the company keep abreast with the ever-changing trends in pharmaceutical industry? We constantly encourage our clients to identify their future needs and monitor macro market trends in order to solidify our future investment strategies. We have grown both through organic investments at our sites and through inorganic investments. In the last two years, we have undertaken several acquisitions, including Coldstream Laboratories for injectable capabilities and Ash Stevens for high potency API capabilities. Further, we constantly work on growing our capabilities and look to invest in technologies that speed up drug development and reduce costs. Another key factor influencing the increase in CDMO services is sponsor companies that want to focus on core competencies internally while outsourcing non-core areas. We support such firms in their non-core areas, with an objective to optimize their resources and channelize them in the right direction. What is the competitiveness of Indian pharmaceutical outsourcing market against the markets of other countries? The Pharmaceutical industry is currently facing several challenges involving a decline in R&D productivity, reduced rate of approvals, absence of blockbuster medicines, policy driven changes in Pharma Bio World

interview healthcare spending- all of which have led to an increased focus on cost, and identification of core areas to focus on. This has been instrumental in companies outsourcing various activities across the drug lifecycle. India is one of the world’s best-known cost efficient manufacturing centers, with the highest number of U.S. Food and Drug Administration (USFDA) approved manufacturing plants outside the US. The Indian CMO/CRO industry has been rapidly moving up the value chain with key players investing in innovation, talent, and capacity. Along with the above, India also offers access to a workforce characterized by historically strong process chemistry skills, a vibrant entrepreneurial ecosystem, robust infrastructure, good communication, and access to individuals trained in leadership across the globe. Growth is also facilitated by attractive terms for investment, a business friendly domestic manufacturing policy that includes 100% Foreign Direct investment. Patented drugs worth approximately US$85 billion in potential annual sales in US are expected to come off patent during 2014-2020, which will place high emphasis on price competitiveness. This will also provide an impetus to the highly cost efficient contract manufacturing set up in India. How will Piramal continue focusing on delivering Quality and Innovation, with a Customer centric approach? With a pool of 700+ scientists, including around 100 PhDs across the globe, we are committed to providing innovative R&D solutions to our clients. Key areas of focus include, Biocatalysis (as chiral molecules continue gain traction), Advanced Flow Reactor systems (flow reactors allow for cost effective and safe manufacture of actives), Route Scouting (our highly successful initiative to develop synthetic schemes that reduce costs and provide 12  September 2017

freedom to operate), and Complex/Novel Formulations (increases bioavailability, e x t e n d s p a t e n t l i f e ) . We e x p e c t o u r investments in these and other areas, to grow, as we firmly believe in the ability of technology to create long-term value. At Piramal ‘Quality as a Culture’ is the key focus as opposed to ‘Quality as a Compliance Tool’. While our buyer who pays for the goods is the pharmaceutical client, we believe that our end obligation is to the patients, who trust our products as lifesaving drugs and to improve their quality of life. Piramal has its own Quality Governance model- QuEST (Quality Empowering Strategic Transformation) that drives the quality strategy to advance our sites beyond compliance. At Piramal, we address the evolving regulatory requirements by establishing even higher internal standards that ensure perpetual inspection readiness. For example, over the past 6 years, Piramal has successfully completed 113 regulatory inspections and 631 client inspections. We have an excellent track record with 100% success rate for inspections at all our facilities. This is a result of audit preparedness, focus on data integrity and a highly skilled team that tracks the latest updates on quality guidelines.

National Institutes of Health (NIH) and the National Cancer Institute (NCI), and has participated in the development of many important drugs through these government a g e n c i e s . To d a t e , A s h S t e v e n s h a s received 14 FDA manufacturing approvals for innovative APIs. As one of the leaders in HPAPI manufacture, Ash Stevens has an impeccable safety record of working with high potency anti-cancer agents and other highly potent therapeutics. The facility has approvals from US, EU, Australia, Japan, Korea, Mexico regulatory agencies. The acquisition of Ash Stevens fits well with our strategy to build an asset platform that allows us to become the Partner of Choice for oncology, globally. Currently, around 25% of the molecules in clinical development are potent. Our clients are looking for reliable partners that can assist them in advancing these programs forward. We can now fulfill client requirements as a single source of supply for both high potent APIs and drug products. This acquisition is synergistic with our Antibody Drug Conjugates (ADCs) and injectable business.

Please appraise us about your recent acquisition deal with Ash Stevens Inc Located in North America, Ash Stevens Inc. is a full service pharmaceutical Contract Development and Manufacturing Organization (CDMO) that has over 50 years of extensive experience in handling highly potent compounds. With the increased demands for its offerings, Ash Stevens now offers comprehensive smallmolecule drug substance development and cGMP manufacturing services. Its FDA licensed cGMP facility located in Riverview, USA specializes in cancer APIs. Further, Ash Stevens is also a long-time provider of contract research services to the Pharma Bio World

Enhance Component Compatibility and Improve Performance West FluroTec® barrier film helps protect drugs by providing a barrier that minimizes interaction between the drug and the closure while maintaining container closure integrity. In addition, the fluoropolymer film reduces absorption and adsorption of the drug product, an important benefit for maintaining the strength and shelf life of most drugs.

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Optimizing Unit Operations in Biopharmaceutical Manufacturing This article examines the material handling challenges pertaining to flow rate and pressure in chromatography, virus filtration and TFF processes and illustrate why the design and operation of the uaternary diaphragm pump  rather than other technologies such as the lobe or peristaltic hose pump  makes it ideal for use in critical biopharmaceutical manufacturing applications. Additionally, the article will show how the uaternary diaphragm pumps ability to operate consistently whether in a fixed stainlesssteel production regime or in the increasingly popular singleuse applications gives it the versatility to optimie biopharmaceuticalmanufacturing maintenance, downtime, changeover and operational costs.

iopharmaceutical manufacturing may come in a wide variety of forms, but every iteration of unit operation must adhere to an unbending set of operational parameters and structures if the desired outcome – a viable, contaminant-free drug suitable for human or animal administration – is to be realized. Three of the more common unit operations within the biopharmaceutical-manufacturing universe are chromatography, virus filtration and tangential flow filtration (TFF). In order for these unique operations to be implemented successfully, though, the operator must be aware of their specific operating characteristics. For example, chromatography requires constant fl uid-fl ow rates during their operations, but may have varying pumping pressures. Virus fi ltration, on the other hand, will feature constant pumping pressures, but fl ow rates will change as the fi lters become clogged or fouled. And in TFF, the main challenge is attempting to keep the fl ow rate and pressure unchanging throughout the process. While fluid transfer is taking place in any of these specific unit operations, it is important to know that the materials that are being transferred can be highly sensitive and delicate (and, in many cases, expensive), meaning that the pumping action must be low-pulsating and low-shear, lest the material be damaged. The Unit Operations

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Let’s start by taking a closer look at three of the more popular unit operations in biopharmaceutical manufacturing: Chromatography Columns

Ra rasa irecor o ales  ndia 16  September 2017

A typical chromatography column, whether it is glass, steel or plastic, is filled with

resins that are compressed in a certain format through which the feed stream product flows and purifies the product by selective adsorption to a stationary phase (resin). Chromatography columns contain complex target-product adsorbing media that need careful handling. Protein A resin, for example, can cost as much as $10,000 a liter, making proper feeding of the resin extremely important. Some chromatography systems require buffer gradients in order to achieve purification of the proteins. Buffers are compounds that are immune to changes in their pH level when limited amounts of acids or bases are added to them. For example, buffering salts have a wide pH range and can effectively stabilize the pH level of the material. Quite often more than one buffer is required, which creates the need to use two or more pumps. In this application, high- and lowsalt buffers are mixed continuously and with changing ratios in order to affect the adsorption of the target molecule to the chromatography resin. Because of this, precise pumping is required to achieve the right pH/conductivity conditions for specific adsorption and high-resolution purification. For example, a Buffer A and a Buffer B can be used to create a gradient that ranges from a low-salt buffer to a high-salt buffer in a linear fashion. Specifically, the process will begin with Buffer A producing 95% of the flow and Buffer B the remaining 5%. Over the course of the operation, the flow rates of Buffer A and Buffer B will decrease and increase in a linear fashion (90% for A and 10% for B, 75% for A and 25% for B, all the way to 5% for Buffer A and 95% for Buffer B)1. This requires a pumping technology that can produce a highly accurate flow with a high turndown ratio that can deliver low and high flow rates as the elution stage continues. Pump pulsation should also be Pharma Bio World

minimized to prevent disturbance of the packed column 2. If the pump is not able to meet these requirements, the correct buffer concentration may not be attained. Also, if the pumping action produces excessive pulsation, the buffers can be susceptible to experiencing spikes in their conductivity. This can affect the purification level of the product as the salt level in the buffer could be compromised. Also, during the loading of the sample, it is not uncommon for the system’s back pressure to increase. Pumps that do not slip offer benefits in these situations since their flow rates will remain consistent and the linear velocity will remain stable. Simply put, a pump with minimal slip will have a more easily controlled flow rate that will need only incremental adjustments to the pump’s speed (measured in RPMs). Virus Filtration In biopharmaceutical manufacturing, virus-filtration systems are used to ensure 18  September 2017

the viability and safety of the drugs that are produced through the removal of potential contaminants from products that are created using cell cultures. Whereas chromatography features constant flow rates and variable pressures, the operation of virus-filtration systems is the opposite – most virus-filter applications use constant pressures with variable flows. In other words, you may have to raise and lower the operation’s flow rate or speed in order to maintain a constant pressure. As mentioned, the flows change as the virus filter becomes clogged. Most typical virus-filtration systems run at a constant pressure, for example, 2 bar (29 psi), due to the nature of the tight pores in the filtering medium, but the flow rates will decrease as the filter’s pores become fouled. When this happens, the flow rate will not decrease in a linear fashion, which will adversely affect the performance of the filter, product yield and overall quality.

Some virus filters have been designed with a flux-decay capacity of up to 90% of the starting flux rate, which requires a pump that has both a high turndown ratio and produces minimal pulsation in the pumped fluid. Evaluation of viral clearance strategies requires demonstration of the equivalence of scalability from bench to manufacturing scale and vice versa3. Spiking studies for virus-filtration use a pressure vessel with a small surface area, which can be as little as 5 cm2 and demand a pump that has low-shear and low-pulsation operation if commercial-scale production levels are to replicate the small-scale studies. The use of low-pulsing pumps in these circumstances can ensure that pressure conditions during validation of the particular filter are not outside of the validated range. Tangential Flow Filtration (TFF) Also known as cross-flow filtration, in TFF the biologic feed stream flows tangentially Pharma Bio World

across the filter membrane at positive pressure. As it passes across the membrane, the portion of the feed stream that is smaller than the membrane’s pore size passes through the membrane. This is different from what is known as normal-flow (NFF), or “dead-end,” filtration, in which the feed flows entirely through the filter membrane with the size of the pores determining 20  September 2017

which portion of the feed is allowed to pass through and which will remain trapped in the filter membrane. TFF is different from NFF in biologic applications because the tangential motion of the fluid across the membrane prevents molecules from building up a compact gel layer on the surface of the membrane.

This mode of operation means that a TFF process can operate continuously with relatively high protein concentrations with less fouling or binding of the filter. To scale up a TFF process there are two variables that need to be successfully controlled. Recirculation (cross-flow) is required to minimize formation of the gel Pharma Bio World

layer and pressure as the driving force to push the permeate through the membrane. The recirculation rate needs to work in conjunction with the pressure (known as the trans-membrane pressure, or TMP, which is the average amount of pressure that is applied to the membrane). Maintaining a constant TMP is critical because if it is too high it can cause gel-layer formation that cannot be removed by recirculation, and if it is too low it results in low flux that will reduce process efficiency. In this instance, pumps that deliver lowpulsation flow characteristics will perform most reliably by decreasing the fluctuation in the variables. So, in considering the functional design of chromatography columns, virus-filtration systems and TFF systems, the common thread in guaranteeing efficient, reliable, cost-effective operation is found in identifying and using a pump technology that is capable of producing both low-pulsation and low-shear operation despite varying flow rates and pumping pressures. The Challenge With these operational requirements in mind, over the years various pump technologies have been used or tested for chromatography, virus filtration and TFF processes. Two that are among the more popular choices of biopharmaceutical manufacturers are lobe and peristaltic pumps. Both, however, have been found to feature operational inefficiencies that may make them insufficient for use in the processes described above. Lobe Pumps Since many biopharmaceutical materials are contained in a low-viscosity aqueous solution, lobe pumps may not be a good choice because slippage can occur during their operation, which can vary between 10% to 100%, depending on the system’s back pressure. Slip will also result in increased shear damage and energy consumption, and if used in a long-duration recirculation loop, 22  September 2017

such as a TFF filtration system, there can be noticeable heat addition to the product that requires significant cooling efforts to protect the product from overheating. Lobe pumps also have mechanical seals, which is a controlled product leak and does not provide full containment unless special (and oftentimes expensive) seals and seal barriers are used. The sterility required in biopharmaceutical handling also means that no outside contaminants can be introduced into the purification process, which is something that pumps with mechanical seals cannot reliably ensure. Additionally, the necessary contact between a lobe pump’s internal parts can lead to wear and the generation of particles that can result in product contamination. Solid particulates, such as undissolved salt crystals, can cause severe damage to the lobes, resulting in damage to the entire manufacturing batch. Lobe pumps will ultimately cost more to operate because of the increase in power required to overcome the pump’s slippage. Peristaltic (Hose) Pumps The main shortcoming of peristaltic pumps is also the most obvious: their method of operation will undoubtedly produce pulsation, and, as noted, pulsation is always bad in biopharmaceutical manufacturing. Peristaltic pumps also have limited flow and pressure-handling abilities. For example, they cannot reliably produce the higher discharge pressures (such as 4 bar, or 58 psi) that are required in some fluid-handling applications. They are also known to release some small quantity of hose material – in a process known as “spalling” – into the pumped product, which can compromise its purity. If the spalled hose material makes its way to the filter, it can foul the filter, making its operation not as efficient as it needs to be, which will also lead to contamination. Also, inconsistency of flow rate will result due to mechanical deformation of the hose

during the pumping process. In the end, the shortcomings of lobe and peristaltic pumps come down to two main things: • If there is shear, which is common in lobe pumps, you will damage the pumped material • If there is pulsation, an operational certainty with peristaltic pumps, you won’t have even flow, and without even flow, you won’t have accurate flow The Solution An effective solution to the operational shortcomings of lobe and peristaltic pumps can be the quaternary diaphragm pump. The motivation behind the invention of the quaternary diaphragm pump goes back 30 years to the mid-1980s, at the time of what is now referred to as the “birth of the modern biotech industry.” In 1986, Frank Glabiszewski was an engineer for a German filter manufacturer and he was growing increasingly frustrated with the overall operation of the pumping technologies that were commonly used in chromatography and TFF applications. “We were using peristaltic pumps but we found out that these pumps were not made for TFF applications. We were checking the marketplace looking for better pumps and spent 80% of our time looking for pumps,” Glabiszewski recalled. “One night I went home and I was sitting in my car frustrated after a pump failure and asked myself a question, ‘Which type of pump did Mother Nature invent to process sensitive biologic fluids like blood?’”4 The answer, of course, was the human heart, and with that in mind, Glabiszewski began working with his friend and engineering partner, Josef Zitron, to perfect the design and operation of the quaternary diaphragm pump technology. When the new technology was finalized in 2000, the pair created a company that would begin producing quaternary diaphragm pumps for use in biopharmaceutical-manufacturing processes. As the duo’s invention grew Pharma Bio World

in popularity over the past 15 years, the technology was also modified so that it could employ disposable plastic heads and wetted parts to make it applicable in the burgeoning single-use biopharmaceuticalproduction marketplace. The operating principle of the quaternary diaphragm pump most closely resembles the operation of the human heart because the four-piston diaphragm technology enables a gentle pumping action through soft “heartbeats.” This action produces four overlapping pumping strokes of the pistons that efficiently reduce pulsation since each stroke of the four diaphragms is generated by an eccentric shaft that is connected to an electric motor. The quaternary diaphragm pump’s method of operation allows it to gently, safely and securely convey low-viscosity aqueous solutions and biopharmaceutical materials that are highly sensitive to shear forces and pulsation while being pumped. Since the four-piston design of the pump does not require any mechanical seals or wetted rotating parts, total product containment is ensured without any abrasion or particulate generation. The pump’s method of operation also produces risk-free dry-running and self-priming capabilities with high turndown ratios. A pump technology with high turndown ratios allows for the creation of a broad flow range, which makes the pump applicable for utilization in a wide range of process applications. With regards to specific unit operations, quaternary diaphragm pumps can be used to pack chromatography columns and then pump the biopharmaceutical material through the column, both of which are critical concerns that require low pulsation with accurate and constant flow rates and pressures. In TFF applications, quaternary diaphragm pumps deliver the consistent flow control that is essential in producing optimal filtrate yields. In today’s evolving biopharmaceuticalmanufacturing processes, quaternary 24  September 2017

diaphragm pumps are also rapidly becoming a first-choice technology in increasingly popular single-use production setups. Basically, a single-use pump enables biopharmaceutical manufacturers to eliminate the cost of cleaning and validating their pumps by using a pump with a replaceable pump head. The result is not only a quicker production process, but one that delivers preferred levels of product purity and sterility with no chance for crossbatch or cross-product contamination. Here are some of the other advantages that can be realized when quaternary diaphragm single-use pumps are used: • Can be used for one product or in one production campaign • At the conclusion of the production campaign, the pump chamber that has come in contact with the fluids is disposed of • Can be used for a set amount of time before the wetted parts are replaced, which eliminates elevated maintenance costs • If the operator needs to use a stainlesssteel pump, the plastic pumping chamber can be replaced with a stainless-steel one • If there’s a pump failure, the old chamber can be taken out and replaced with a new one in five minutes • Used when cleaning in place (CIP) or steam sterilization is not practical or possible. This represents a significant simplification and cost reduction to the overall process as there are no contaminated cleaning chemical and water solutions that need to be treated and disposed of. The costs to properly treat and dispose the cleaning fluids can alone be the driver to require use of single-use alternatives. Of course, not every pump technology is completely perfect for every characteristic of a specific fluid-handling application. In this instance, the design and operation of the quaternary diaphragm pump limits it to handling fluids that have a maximum viscosity of 1,000 centipoise (cPs) and that contains particulates up to 0.1 millimeter in diameter.

Conclusion The importance of biopharmaceuticals means that any and all products must meet strict demands regarding their manufacture. This includes ensuring that no damage is done to component materials during critical chromatography, virus-filtration or TFF processes. While lobe and peristaltic pumps have been preferred pumping technologies for these unit operations, a better choice can be the quaternary diaphragm pump, the operation of which greatly reduces the chance that pulsation and shear will compromise the safety and effectiveness of the end product. References: 1. h t t p : / / w w w . p a l l . c o m / m a i n / biopharmaceuticals/product. page?id=33058 2. L. Hagel, G. Jagschies and G. Sofer, Handbook of Process Chromatography: Development, Manufacturing, Validation and 3. Economics, 1997 4. H. Aranha and S. Forbes, "Viral Clearance Strategies for Biopharmaceutical Safety" Pharmaceutical Technology, June 2001 5. Video: "Quattroflow TM: The New Standard in Biopharmaceutical Pump Excellence"

Contact: glenn.hiroyasu@psgdover.com Pharma Bio World

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Advances in mAbs Technologies with Changing Business Environment Monoclonal antibodies (mAbs) are currently being used as the leading therapeutics for several diseases across the globe and are being used for treatment of cancer, immune disorders, and infections. This article discusses how the patent expiry is impacting the mAbs manufacturing business framework and is being influenced by the design drivers - to be the first in the market.

onoclonal antibodies (mAbs) contribute almost 60 per cent of market revenue among the top ten bestseller drugs worldwide. Growth of biosimilar market is driven by the numbers of patents getting expired in the coming years, regulations and guidelines for manufacturing of different class of biosimilars and potential demand of these products. Although, a few new mAbs that have gained regulatory approval in last few years, it is expected to have 0 mAbs product in global market by 2020. With more number of new mABs, coupled with the expiry of the patents and more affordability is expected to generate the overall sales of nearly USD 125 billion in next 4-5 years. [1]

The patent of some of the 1st generation mAbs have expired and few more are expected to expire in coming years and this has triggered the development of mAb Biosimilars in the estimated time frame [3]. The patent of drugs such as Rituximab/MabThera, Remicade, Herceptin, Humira, Avastin, Synagis, Erbitux, Ran Raesh Gupta Subject Matter Expert / Director, Process NNE Pharmaplan India Ltd Gaurav bhishe Process Engineer, Biotech NNE Pharmaplan India Ltd

Niharia Ruhela Process Engineer, Biotech NNE Pharmaplan India Ltd Tushar Suhdevrao Shende Process Engineer, Biotech NNE Pharmaplan India Ltd Pharma Bio World

and Lucentis are due to expire in the coming years and the manufacturers are in no mood to let this opportunity go. Market for mAbs is expected to grow in near future due to, patent expiry of few block buster drugs and new products in pipeline. European and US market is wide open due to the patent expiry which influence the Asian drug makers. [3] It is expected that the emerging biosimilar market, especially in China, India and Brazil will record high growth rate driven by costeffectiveness of biosimilars and the growing awareness supported by growing healthcare infrastructure in these countries. Manufacturing Initiatives The common and robust manufacturing platform for mAbs are key for the commercial manufacturer and success for the product. The advent of Biosimilars is driving a desire to achieve lower cost of goods and globalize biologics manufacturing. Biosimilars are the major advantage to reduce the cost and globalize the manufacturing.

Trade name

Type

 Sales SD millions

Patent xpiry S

Adalimumab

Humira

Biologic

1608

2016

Ledipasvir/ sofosbuvir

Harvoni

Small molecule

081

2030

Etanercept

Enbrel

Biologic

884

201

Rituximab

Mabthera, Rituxan

Biologic

8583

2015

Infliximab

Remicade

Biologic

82

2018

Lenalidomide

Revlimid

Small molecule

64

202



Bevacizumab

Avastin

Biologic

652

201

Trastuzumab

Herceptin

Biologic

651

201



Sitagliptin

anuvia

Diabetes

6110

2022

Insulin glargine

Lantus

Biologic

6054

2014 September 2017  25

Brand Name

Generic ver sion

Patent expiry

Indication

Company

Humira

Adalimumab

2018

Crohn's disease, chronic plaque, Rheumatoid arthritis

AbbVie

Mab Thera

Rituximab

2018

Chronic lymphocytic leukaemia, Non-Hodgkin's lymphoma, and rheumatoid arthritis

Roche

Challenges of Continuous Manufacturing

Outsourcing Assembling biosimilars needs particular capacities, fastidious arranging, critical budgetary interest in hardware, exceptionally talented staff, innovation, work force, and materials. The intricacy and costs required in biosimilar advancement keep on rising till they accomplish economies of scale, hampering the underlying achievement of biosimilars production. Subsequently, numerous merchants are progressively deciding on contract fabricating associations and contract examine associations with set up proficiency in the field of assembling biosimilars. These associations are creating and approving explanatory strategies to enable pharmaceutical organizations to stay focused and monetarily feasible in the market. Additionally, producing biosimilars in creating nations, for example, India and China has lessened the imperative venture by around 40 per cent, making India and China a centre for outsourced biosimilar fabrication. Outsourcing the manufacturing process for biosimilars to developing nation will help the supplier to new products in the market in more efficient and cost effective manner. [2] New Technologies Additionally; new trends and technologies are coming in the manufacturing of mAbs like Single use technology, Continuous manufacturing etc which are providing pace to the mAbs biosimilar manufacturing. These mABs based drugs are used for treatment of Cancer, immune disorders, and infections. mAbs manufacturing market is induced by numerous drivers, like cost effective treatment, growing number of patent expiry, favourable regulatory requirement. [3] 26  September 2017

• • Planning and scheduling is a routine action.

Development of biosimilar in comparison to the reference product will consume potentially less time and revenue, since there is no requirement to carry out the process at R&D scale and few stages at clinical trial can also be saved. Due to the fastest growth and profit in mAb business, the new era of the mAb manufacturing facility requires agility, dynamics and flexibility. Introduction and adaptation of Single use and continuous manufacturing technology is giving pace and flexibility to the mAb business. Continuous manufacturing facilities are most cost effective as one can produce faster with smaller footprint requirement of the facility, less manual intervention, and investment. Single facility can be used to manufacture multi product by opting combination of single use technology as the product change over time will be less and chance of cross contamination will be nullified. The continuous operating facilities are expected to be more efficient (in terms of productivity, less changeover time for cleaning and validations) compared to a batch bioprocessing facility.

• • One major challenge is the existing batch infrastructure that many companies already have in place. When this occurs, companies are reluctant to invest in novel machinery and technologies. • • Another challenge is the pervasive mindset of the industry that pharmaceuticals should be produced via outdated methodology simply because that is the way it has always been done. • • Also, there is a lack of experience in continuous manufacturing at most pharmaceutical companies, which is a result of decades of batch manufacturing. [5] This is reinforced by the notion that regulators will balk at approving novel processes. We consider this belief erroneous, based on actions taken by the U.S. FDA and other regulatory agencies (e.g. the FDA has approved drugs produced in a continuous fashion). Benefits to Continuous Manufacturing There are many pros of continuous bioprocessing, many of these similar and complementing those of single-use systems.

• • Reduced time to market: One identical platform for product development and market launch. • • Process cycle time reduction • • Reduced CAPEX and OPEX costs • • Closed system without hold • • Smaller facility footprint requirement • • Easy scale up • • Increased productivity • • Improved quality • • Optimum utilization of resource • • Increased flexibility

At present, we see a merging of these two correlative techniques as manufacturers try to coordinate single-utilize frameworks into a nonstop generation stage. This speaks to an outlook change in how biotherapeutics are fabricated, and it offers promising advantages for the two producers and customers. [6]

Limitations to Continuous Manufacturing [4]

Characteristics Manufacturing

Flexibility to accommodate and process number of products does not exist.

Continuous

Continuous production is used under the following circumstances:

•• Dedicated equipment with zero flexibility. •• Process handling is fully automated. •• Component materials cannot be readily identified with final product.

• • Very high investment for setting flow lines. • • Product differentiation is limited. • • If contamination occurs, huge volumes of product may be lost • • PAT implementation • • Required Intensive Planning: To prepare for the change-over, substantial Pharma Bio World

work is necessary regarding detailed design, preparation, project planning, scheduling, and plans for ongoing maintenance and improvements. •• Costs Significantly to Implement up Front: Purchasing or adapting machinery to be more flexible is costly. Regulatory Challenges The continuous manufacturing is an upcoming technology and it comes with its own package of challenges at the operational level. As mentioned earlier; the continuous manufacturing system is quite complicated, requiring more skilled labour and more expansive technological expertise. An extensive network of software and hardware must work together well consistently. Some of the regulatory challenges faced by the industry exploring in to continues manufacturing includes:

•• •• •• •• ••

Batch/ lot definition, Process dynamics, Bioburden management Deviation management and Lot traceability Definition of design space for continuous manufacturing

Defining the Batch Defining a batch in continuous manufacturing platform is important aspect so as to be able to investigate in case of any deviation, recall the product or if anything goes wrong. Batch - a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture Batch refers to the quantity of material and does not specify the mode of manufacture Lot - a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. Pharma Bio World

Definitions for both "batch" and "lot" are applicable to continuous processes Batch Definition for CPP could be based on the specific time period or/and amount of product produced. Within specified time period, the product uniformity/ consistency must be maintained and it should be within the critical process parameters. Control strategy can be implemented to do the same. Material traceability is an important requirement to identify deviation or nonconformity which includes raw material used, Media/buffer used etc. Process Dynamics Intensive studies are required to understand the process dynamics at the development stage and suitability of materials throughout the process as well as the impact of variations in feed, media and buffer at Continuous Process platform. Bioburden Management Opting single use system, closed process and filter arrangement at appropriate intermediate process steps will help to control the bioburden. Filter sizing and filter change frequency is the challenge for bioburden control in continuous manufacturing and it can be resolved by proper risk assessment and characterising the intermediate product. Deviation Management Traceability

and

Lot

To guarantee batch/ lot in term of quality, residence time distribution model can be used. This will help to identify deviations/ non-conformity throughout the batch/ lot. This model will help to have complete visibility and control over any deviation, and manufacturer will have the option to discard the affected lot or portion of batch. Design Space Bioprocessing

Way Forward The biopharma industry is highly regulated one and the regulators should be fully convinced that the there is no compromise done with the drug quality and safety as far as the patients are concerned. For molecules already in manufacturing; it is difficult to switch over to the continuous mode because of the regulatory pathway. However, for manufacturers which are in early stage of development of biosimilar - post patent expiry in vision; it is much easier to adopt to the new technology. To support this; there is a significant regulatory push in the direction of continuous manufacturing, especially from US FDA and other agencies which are in favour of the advanced control strategies associated with continuous manufacturing. The updated European regulations on e.g. process validation and other GMP aspects are enabling this direction and it is becoming increasingly clear that industry is pushing on an open door when it comes to regulatory endorsement towards continuous manufacturing. References: 1.

3. 4.

Continuous

Concept for the design space used for batch processing can be utilized for continuous process platform. Critical process parameter for individual unit operation can be linked to the critical quality attributes and each unit operation altogether links into a controlled strategy.

Why Monoclonal antibodies (mAbs) are the Future of Medicine; Yale Books Unbound. August 2015. Top 4 Trends Impacting the Global mAb Biosimilars Market Through 2020; Technavio. October 2016. Sample Report - Global Mab Biosimilars Market. What is holding Industry back from Implementing Continuous Processing: Can Asia Adopt More Quickly?; Eric Langer, Managing Partner, BioPlan Associates, Inc. Rockville, MD USA. December 2015. An exclusive Q&A with CONTINUUS Pharmaceuticals on continuous manufacturing operational best practices and trends for 2017; Meg LaTorre-Snyder. December 2016. Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing; Jerry Martin. October 2016.

Contact: SDVE@nne.com September 2017  27

Is Health a Subject Matter of Veg Vs Non Veg?                    

ndian healthcare is experiencing a new wave of opportunity. Providers are reinventing existing delivery models to bring healthcare closer to the patient. The following emerging trends are changing the course of the industry: • The change in the government’s role from provider to payer has expanded the financial risk protection coverage to the marginalised. • Private sector partnerships through health PPPs are gradually gaining acceptance, thereby improving access to care. The Indian pharmaceuticals market is third largest in terms of volume and Fourteenth largest in terms of value in the world. The country's pharmaceutical industry expanded at a compound annual growth rate (CAGR) of 9.4 per cent in 2013 to reach around USD 30 billion in 2015 and is expected to expand at a CAGR of 23.9 per cent to USD 55 billion by 2020. In terms of value, exports of pharmaceutical products from India increased at a CAGR of 26.1 per cent to USD 10.1 billion during FY06–13.The country’s pharmaceuticals industry accounts for about 2.4 per cent of the global Pharma industry by value and 10 per cent by volume. The generics market is expected to grow to USD 26.1 Billion by 2017 from USD 11.3 Billion in 2011.(IBEF). Considered to be a highly fragmented industry, consolidation has increasingly become an important feature of the Indian pharmaceutical market. Pharma Vision 2020 by the government’s Department of Pharmaceuticals aims to make India a major hub for end-to-end drug discovery.

           28  September 2017

India is considered a privatized health economy and around 80 per cent of healthcare expenses are borne privately,

with majority being out of pocket expenses; in this, India is quite different from the USA where insurance pays for more than 90 per cent of health related expenditure and the UK, where a National Health Service covers majority of costs incurred. As, per capita income in India was also low (USD 1800 in 2014), and neither universal healthcare nor universal insurance were available, affordable access to medicines was considered a key policy goal of the Indian government. Thus, economic generic alternatives to expensive medicines were widely available in India which in turn, reduced the likelihood of high priced therapies launching successfully. Given the low per capita income and the lack of universal health care provision and the privatized health care access, the Drug Price Control order came into existence to fulfil a key policy goal of the Indian government - to provide increased access to medicines to people at an affordable price. National Health Policy 2017 is sensible and comprehensive. Significantly, the policy takes a holistic view of the health system and achieving better outcomes across elements of access, cost and quality — all closely inter-related. The policy looks to increase access to care by expanding coverage to the underprivileged and under-served and focuses on primary healthcare packages with geriatric, palliative and rehabilitative services. It also looks at increasing hospital beds to 2 per 1,000 people from an appalling 1.3 in 2012. Importantly, there is a commitment to increasing the public spending on healthcare to 2.5 per cent of gross domestic product (GDP) to help finance these initiatives. The health policy has also sensibly focused on being cost-effective by Pharma Bio World

focusing on preventive and promotive care and trying to fundamentally change the paradigm from sickness to wellness. This is the need of the hour as its cost effectively improves outcomes. In fact, early intervention reduces costs by 10-20 times vis-a-vis late treatment in the case of diabetes and leads to 85 per cent reduced costs and a 2 times increase in survival rates for cardiovascular diseases. Useful lessons can also be learnt from countries such as Singapore which have delivered world-class outcomes by spending among the lowest levels on healthcare (around 4.5-5 per cent of GDP). Other health systems show that a focus on primary care reduces the mortality and morbidity of cancer and cardiovascular diseases by a good 20-50 per cent. It is also great to see the focus on outcomes such as life expectancy and diseasespecific targets. Worryingly, we have missed achieving millennium development goals in infant and maternal mortality. And, if we don’t address the epidemic of non-communicable diseases, our growth potential will be gravely undermined. The policy also focuses on quality, recognizes the role of the private sector and envisages the creation of a public health management cadre to optimize health outcomes. Talent is a constraint at multiple levels and acceleration of capacity is critical to driving access, which the emphasis on affordability alone will not solve. The PHD Chamber of Commerce & Industry ( PHDCCI) has submitted a representation to the Expert Committee headed by Dr. C. K. Kokate, Chairman, Expert Committee, DGHS, Ministry of Health and Family Welfare, in regard to the replacement of Gelatin Capsules with Cellulose Capsules as also the safety and vegetarian or non vegetarian aspects concerning Gelatine capsules versus HPMC capsules. Pharma Bio World

It may be noted that the DGHS vide notice dated June 02, 2017, had sought views of various stakeholders to address all the technical issues pertaining to replacement of gelatin capsules with cellulose based capsules for encapsulation of drugs. The notice states that “A proposal has been received to replace gelatin capsules with cellulose based capsules which are of plant origin and are safe for use as compared to animal based gelatin capsules”. Ministry of Health and Family Welfare vide order dated 20.03.2017 has constituted an Expert Committee to address all the technical issues pertaining to replacement of gelatin capsules with cellulose based capsules for encapsulation of drugs. The Committee has desired that views of stakeholders including manufacturers/ marketers of HPMC capsules as well as NGOs who are working in this area or involved in this subject may also be obtained so that a considered view can be taken in the matter. In order to examine the pros and cons of the proposal, suggestions/comments are invited from the Stakeholder/NGOs/Consumers within 21 days. In the meanwhile, soft gelatine capsules have been given a go-ahead, therefore there is no prima facie issue with the raw material and hence the replacement of the hard gelatine capsules being non-vegetarian is totally misplaced and uncalled for. In this connection, at a meeting of the Technical Advisory Board (DTAB) of the CDSCO (the apex body to decide on technical issues) on May 13, 2016, a proposal to label cellulose based capsules with a green dot to indicate its vegetarian origin was considered. The DTAB turned down the proposal for the required amendment of the Drugs & Cosmetics Act

on the basis that unlike in the caseof food items, the choice of drugs is not that of the consumer (the patient) and is based on the prescription of the doctor where considerations of vegetarian origin or animal origin has no relevance. DTAB also recorded its observation that HPMC capsules are made from a semi synthetic chemical and hence cannot be considered of vegetarian origin. The Supreme Court, in its order dated March 07, 2013, Case No. 641, had ordered that there is no need for non-veg or veg labels on drugs or cosmetics and hence even the red dots which are printed on non-veg products was not implemented for medicines. Gelatine Capsules are consumed by people at large as carriers of important medicines used to cure many terminal and lifestyle diseases. The consumption of medicine is more curative than out of personal choice. Looking at basic fundamental, it is not prudent to enter the Vegetarian and Non-Vegetarian debate in this matter. It may further be noted, that Gelatine used in the manufacture of empty capsules are derived from an extraction process wherein no animals are harmed or killed for this specific purpose. Only the left over bones having hydroxide and collagen, which is a protein widely found in animal bones (and is not more than 2 per cent of the total value of the dead animal) is extracted through sophisticated machineries in WHO GMP approved extraction and manufacturing plants. Accordingly it is misplaced to have any notion that Gelatine Capsules are non-vegetarian in origin. Gelatine capsules are totally safe for human consumption. WHO as per evidence certifies Empty Hard Gelatine Capsules for its total safety for Human Beings. And so do the Pharmacopoeia of USA, Japan, European Union, United Kingdom, Australia and India. September 2017  29

When a scientific body of the Government of India, the Indian Pharmacopoeia Commission, publishes a monograph on gelatine and empty gelatine capsules how can it then be unsafe? Presumably, the ultimate test of safety of a product is if it conforms to the specifications given in a pharmacopoeias, Several other pharmacopoeias around the world, including the British Pharmacopoeia, the United States Pharmacopoeia, and the Japanese Pharmacopoeia have confirmed its safety. Inspite of the repeated requests Professor Kokate’s committee has not yet replied to stakeholders as to why gelatine capsules are less safe than HPMC (cellulose) capsules and what is the scientific and technical evidence for the same, if any. Across the globe over 95% of capsule formulations are gelatin capsules and even among the rest 5 per cent, HPMC is primarily used for nutraceutical formulations. In India only around 2 per cent capsules are HPMC based and almost all of them are nutraceuticals. No cellulose capsules are used for products such as antibiotics, oncology, anti-infectious, painkiller and other medicinal categories. Nor have any tests been carried out by the DCGI in India whether such medicinal products would maintain their stability, bio-availability, bio-equivalence and other properties if filled in Cellulose capsules. Technically speaking:

especially if the medicine has Potassium ions. Similarly for a few of the drugs, Cellulose capsules were better than Gelatine capsules. • At the same time a study of end of shelf life performance for cellulose based capsules needs to be conducted and, hence, the issue of replace of Gelatine should not be taken hastily • The time taken for the above tests of bioequivalence of thousands of drugs and combinations and Pharmacokinetics and Pharmacodynamics properties will take several years followed by the long process of approval from the drug authorities and any such move could mean devoiding the 1.2 billion people of this country of basic medical and health services for that many number of years. Following are the pointwise clarifications detailing the Myths and the Reality: MYTH -1 HPMC capsules are used extensively in many countries Reality Over 95 per cent of capsule formulations are gelatin capsules and even among the rest 5 per cent, HPMC is primarily used for nutraceutical formulations the World over . In India only around 2 per cent capsules are HPMC based and almost all of them are nutraceuticals.

• Pharmacokinetics and Pharmacodynamics properties of the drug has to be tested before it is put in to the market if the drug is encapsulated in Cellulose Capsules

MYTH -2

• Bioequivalence study for each drug would have to be carried out also.

Gelatin has been used for hard and soft capsules over the last 100 years and so far there has been practically no reports of severe or even moderate adverse

• HPMC

capsules

30  September 2017

are

not

suitable

HPMC is safer than gelatin Reality

effects. On the other hand HPMC for Hard Capsules are of recent origin. Unlike in the case of production of Gelatin, HPMC manufacture involves use of reagents and chemicals, some of which are potential carcinogens, in a multi step process.. The track record of HPMC use is just a decade or even less and therefore it is difficult to predict safety over time. MYTH -3 HPMC of the right grade is readily available Reality The limited use of HPMC in India is dependent on imports (mostly from China) and it is not clear whether new generation HPMC, recommended for capsules is readily available and if they are, at what prices. MYTH-4 Replacement of gelatin by HPMC does not require new regulatory approvals Reality Any change of formulation and introduction of a new material or excipient is considered a New Drug under Schedule Y of the D&C Act. That means that every replaced formulation (with HPMC) of every API needs to be validated for safety, efficacy and pharmacokinetic parameters of dissolution, disintegration, release and stability through fresh pre clinical and/or clinical investigations. In fact if all hard gelatin capsules in the market ( close to 20,000 packs) are to be replaced, it will take several years to get them tested and approved and costs would be enormous and that too at a time when every one is attempting to reduce healthcare costs to make it more affordable for the masses. Pharma Bio World

Change over to HPMC will not add to higher costs of the capsule formulations

The process being different, considerable modification and fresh investments in new machinery would be required to produce HPMC capsules

Reality

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95 per cent of the Gelatine manufactured in India is produced by the PHDCCI Association members.

APRIL-MAY 2017

Gelatine is used in Blood plasma substitutes, Haemostatic sponges, Surgical implants, Hydrocolloidal dressings, Collagen for skin cream and Dietary supplements, certain food colours, vaccines, apart from auxiliary treatment for degenerative arthritic diseases and many other products, including a large number of food products.

MUMBAI

Pharma Bio World

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Pumps, Valves, Actuators, Pipes & Fittings

International Exhibition & Conference 21-23, February 2018 : Mumbai, India

JASUBHAI MEDIA PVT. LTD. Taj Bldg., 3 rd Floor, 210

MYTH – 8 Present plant and machinery can be utilized for manufacture of HPMC capsules

Mumbai

If it is an issue of non-vegetarian versus vegetarian capsules, then it should be noted that there has never been a bias against non-vegetarian sources in the manufacture of medicines. Products from non-vegetarian sources are currently widely used in many segments of pharmaceutical industry.

VOL. 14 ISSUE 3

While HPMC is based on Cellulose to start with, it undergoes chemical reactions involving building of new covalent linkages and hence is a chemical by definition and not a natural material

Quality by Design

APRIL-MAY 2017

Reality

www.pharmabioworld.com

OFFSHORE WORLD

HPMC is plant based and therefore natural

` 150

MYTH – 7

MUMBAI - 2019

TOTAL PAGES 60

Raw materials used are waste products of animals and animal derived foods, which are environmentally unsafe and difficult to dispose off . Converting them to Gelatin and derived products adds value to waste material and offers solution to waste disposal issues. No animal is slaughtered for manufacture of Ossein, Gelatin and derived products

23-25, January 2018 20-23, February 2019 Venue: Ahmedabad, Gujarat, India Venue: Mumbai, India

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Reality

GUJARAT - 2018

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MAY 2017

Animals Are Slaughtered For Raw Material (Bones, Hides, Fish Scales Etc.) To Manufacture Gelatin

HYDERABAD - 2017

VOL 15 ISSUE 10

MYTH – 6

With the stoppage of Gelatine Capsules, both Cellulose capsules and Cellulose raw material will have to be imported at huge foreign exchange cost mainly from China, there by further increasing our dependence beyond the APIs which itself is quite precarious. Additionally the capacity to supply HPMC capsules simply does not exist from overseas manufactures.

PHARMA BIO WORLD

At present prices of HPMC , it is estimated that the costs of production of HPMC capsules will be considerably higher and so too prices. The new generation HPMC which is preferred for use in capsules is still patent protected and hence patent holders will have monopoly on prices.

Contact: arun@phdcci.in

Dr. D. N. Road Fort, Mumbai-400 001 Tel.: 91-22-40373636 Fax: 91-22-40373635 E-mail: industrialmags@jasubhai.com

September 2017  31

Falsified Medicines Directive: Don’t Lose Track of Compliance                     

he Falsified Medicines Directive (FMD), otherwise known as Directive 2011/62/EU, was implemented in July 2011 due to a marked increase in falsified medicines making their way into European supply chains. Member states of the EU were required to comply by January 2013, which added to the already heavily regulated sector, and licensing, manufacturing and distribution of medicines remains tightly controlled. Increases in the number of falsified medicines globally have been dramatic. In 2013, the World Health Organization (WHO) launched a global surveillance and monitoring system designed to encourage Member States to report incidents of substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products in a structured and systematic way. Up until January 2016, 920 medical products had been reported across all main therapeutic categories and included both innovator and generic medicines from inexpensive pain medication to very expensive products for the treatment of cancer. Benoit Goyens of the World Customs Organization (WCO), speaking at the Medicines for Europe Conference in Croatia last year, predicted that criminal organisations could generate up to £1bn in 2017 from the sale of illicit medicines – many of which will be purchased through seemingly bona fide websites via the internet. The figures are staggering, therefore improvements to the regulations were necessary to help in the fight against this highly dangerous, often fatal , practice. What are falsified medicines?

       32  September 2017

Falsified medicines are products that have been made illegally to ‘mimic’ real medicines. Essentially they are fakes that pass themselves off as the real thing. The ingredients used in these products can be of a significantly lower quality than the approved genuine version and often have

lower levels of the active ingredient require for effectiveness. Dosage levels can also be wrong, or the wrong ingredients altogether could be used in their preparation, and fake packaging is generally used to conceal the source of the product and the identity of its manufacturer. Medicines that are falsified are often confused with counterfeit products and it is very important to make the distinction between the two. While counterfeit products are illegal, they are generally produced using patented technologies that are not the rightful property of the manufacturer. This technology can be used accurately to produce medicines that do not comply with intellectual property rights or trademark laws – thus making them counterfeit. Falsified medicines, by contrast, represent a higher risk to the public as they are made to resemble genuine products. Unfortunately, this distinction between falsified products and counterfeit products made in the EU is not necessarily used around the world, and in the language people use they will sometimes refer to counterfeit when they actually mean falsified. How has the FMD changed where coding and marking is concerned? The introduction of the FMD has presented challenges to the pharmaceutical industry, in that it requires a far higher level of data management than ever before. Section 11 of the FMD states that: ‘Safety features for medicinal products should be harmonised within the [European] Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products. Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering’ . These requirements were set out recently in a Deregulated Regulation (EU2016/161), Pharma Bio World

published in February 2016. It states that two new safety features must be present on the packaging of most medicines that are intended for human use – a unique identifier and an anti-tampering device. Serialization will be required at secondary pack level, information for which must be provided via a 2D barcode and in human readable form. The information present must include a unique serial number, expiry date, batch number and product code. At present, there are differences that exist in terms of classification of medicines. Some member states may consider a product a prescription item, for example, while another deems it an over the counter product. The directive only applies to prescribed medicinal products so, depending on the destination country, a national reimbursement number may also be required. This will be added by manufacturers and repackagers accordingly. Products will need to be guaranteed authentic via an end to end verification system, in addition to risk-based verification by wholesalers. A final level of security is provided by further verification of the product at pharmacy level – ensuring authenticity at point of sale. For products sold via the internet, a new online logo has also been designed to indicate companies that are operating legally. This can be clicked to check the authenticity of the company in question against a verified database. These new measures will apply as of 9 February 2019.

Coding and marking – a vital piece of the FMD puzzle The two most common technologies for serialized marking are laser and thermal inkjet (TIJ), as both are able to produce high resolution codes that meet the detail requirements for 2D DataMatrix codes. TIJ printers fire tiny ink drops onto 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 underneath each Pharma Bio World

nozzle. These resistors boil a small amount of ink which creates a small steam bubble that propels the ink drop. In contrast, laser coders 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. In the first instance, manufacturers should look at the packaging substrate they intend to code or mark. Pharmaceutical cartons and paper labels are commonly used and often feature an aqueous overcoat to protect the packaging material. Historically this would be an issue for TIJ, as water-based inks would not adhere to the surface of the packaging. Advances in ink technology, however, have seen the introduction of methyl ethyl ketone (MEK) or other light-solvents - broadening the spectrum of applications TIJ can address. Substrates such as foils, films, plastics and coated paper stocks are all now addressable with a TIJ technology that utilizes MEKbased inks. Laser systems are able to mark on a wider range of materials, such as paper, plastics, metal and glass. Lasers are also able to code on curved surfaces such as vials or bottles. There are two considerations when it comes to verifying suitability of the substrate with laser technology: absorption of laser light and creating a print window with sufficient contrast for high quality codes. Absorption is a function of the substrate and the selected wavelength of the laser and the correct combination should be recommended by an expert coding and marking supplier. For proper code contrast, it is commonly required to modify packaging with a print window of dark ink, referred to as a “flood fill.” The laser burns off the top layer of dark ink to expose the lighter underlying substrate – making a negative image. Data management is critical Manufacturers will find it necessary to adopt track and trace technology to enable compliance with the FMD and its associated delegated regulations, and the ability of

coding and marking systems to interact with these technologies cannot be overlooked. There are a number of ways in which these interactions can take place. Asynchronous communications, for example, allows the coder to send unsolicited information to the line control system. This functionality provides the dual benefits of active notification of a printer event and reduced network traffic, which translates to faster notifications and higher potential throughput. Remote communication protocols too enable sensitive information and commands to be passed between the coding system and the host data system. This is important to remember when choosing a coding and marking system, as using a printer that features a tested, validated and secure protocol and command set designed specifically for managing sophisticated communications is critical. Finally, buffer management is key to consider. Can your chosen system code and mark unbuffered, where variable data is received and printed one record at a time, or buffered, where multiple records are sent at the same time but are only printed once each. These features are particularly important to consider in countries where serial numbers have to be purchased. Correct management will enable manufacturers to redeem those codes that have not been used, which represents a useful cost saving. Whichever technology is best for your individual needs, what is clear from the legislation is that coding solutions for FMD need to feature robust data management, seamless integration into manufacturing equipment and high resolution print capability to convey information throughout the supply chain. Through working with an expert supplier, manufacturers can ensure that the products they produce can be 100% authenticated at all points along the supply chain – helping to make the illegal falsification of medicines a far more difficult practice going forward. Contact: itan@abipr.com September 2017  33

How Technology Transform the Pharmaceutical Industry in India                                      

arket in general, has been greatly impacted by the might of technology and the Pharmaceutical sphere is not lagging behind. Catalysts such as Mobile communications, the cloud, advanced analytics, and the Internet of Things has influenced the way pharmaceutical industry operates, with players opening their visions to the disruptive potential. Yet many find it hard to determine what initiatives to scale up and how, making it a precarious yet enriching ally to bring on the table. Here are a few Trends reshaping healthcare: Patients are becoming more engaged In the current digital age, patients are increasingly able to take greater control of their own health, decreasing the blind dependence on prescriptions to a minimal level. They feel empowered by the vast amount of health information available online and on apps. With an array of health and fitness wearables such as FitBit and Apple Watch, consumers have grown confident in their ability to take responsibility for their health, alongside becoming keener to evaluate different healthcare products and services, making it patient engagement a key to the success of any pharma organization. Digital-centric competitors are moving in

a aa        34  September 2017

Insights into clinical pathways are no longer the prerogative of the traditional healthcare establishment, as technology companies such as Apple, IBM, and Qualcomm Technologies moving into healthcare with their vast array of solutions to aid consumers. These are able to engage with patients through apps, health and fitness devices, and online communities, collecting petabytes of data

while capturing valuable insights. Pharma companies need to optimally position themselves for competition/collaboration, while building complementary capabilities . More information is available about product performance Gone are the days of pharma companies controlling both the generation and dissemination of information as Digital technologies spurred an array of new, independent information channels for sharing and discussing patients’ experiences, advanced data aggregation and analysis to link disparate, complex data sets and generate new insights into drug safety and efficacy. Players are building channels to anticipate these new sources of evidence, and respond efficiently. Efficiency and agility is improving dramatically Advanced analytics, sensors, and the automation of complex decisions are delivering a remarkable change in the efficiency, speed, quality, and responsiveness of the pharmaceutical operations. Players are deploying nextgeneration technologies to streamline their business processes, through championing real-time transparency of their clinicaltrials and frictionless sales and operations planning, while satisfying new expectations in efficiency and agility from customers, employees, patients, and suppliers. Personalized care The ability to personalize interactions with stakeholders may have been a fodder for post 70’s science fic fares, but in the present generation, it has risen to Pharma Bio World

be a key value driver in pharma. This is facilitated through the use of sensors and digital services, providing tailored care on a monitored basis. Medication has become personalized, targeting the needs of each patient with greater precision than before. Advanced data analytics that mine electronic medical records, including diagnostic results, medication history, and genomic, proteomic, and gene-expression data are helping identify optimal therapies, while predict how individual patients will respond to treatment. Omnichannel conversations physicians and patients

with

Digital-engagement technologies open up a whole new world for marketing, the exchange of information, and recruitment for trials. Pharmaceutical sales reps, medical-science liaisons, and patientservice teams can inform and influence patients, physicians, and caregivers in person or via mobile phones, the Internet, apps, or social media. Virtual care is becoming become increasingly commonplace with specialist virtualcare apps ruling the roost. Consultation through medical portals and social media Pharma Bio World

have become a thing to vouch for as patients to use Skype to call their general practitioners. Data-driven insight: Advanced analytics to increase pipeline and commercial value Pharma companies are utilizing a wealth of data, usually locked away in different technical and organizational portals, for the growth of their trajectory. Some are already linking and mining their data sets to improve their pipelines, products, and strategies.Insights are being harnessed through use of AI to cull out valuable data that would help conjoin patient’s data to give rise to a well rounded perspective. Healthcare devices to monitor personal health and robot-assisted surgeries are direct results of successful AI integration, replacing the need for human reviewing. This in turn, has made operations and diagnosis possible on a much rapider pace, decreasing time taken to recover to a minimum level.

patient outcomes, putting an even greater pressure on pharmacy companies to demonstrate the value of their drugs in the real world to retain market access and premium pricing. In this technologically charged atmosphere, digitally enabled “an extent beyond the pill” solutions, which including not just drugs but also sensors to collect and analyze data to monitor a patient’s condition, have become the season’s favourite. These solutions are driving the adherence to treatment and outcomes that consumers and governments seek, while maintaining a delicate balance between technology and humanity. Conclusion Although these may be minor changes, but as it takes small ripples to create a storm, these too will usher in a breath of fresh air for everyone to sit up and take notice.

Outcomes-based care is moving to center stage Playersn have adopted a sharper focus on managing costs while delivering improved

Contact: monalisadas@mediamantra.in September 2017  35

Market Research

Time to Look at Pharma Funds

e think it may be a good time to relook at Pharma funds after the pharma stocks have seen a large de-rating over the last almost two years. While we do not expect a sharp and immediate upmove from here for pharma stocks and hence pharma funds, SIP in pharma funds could generate decent returns over 1-3 years at a time when the other sectors/stocks seem to be close to topping out/have already have topped out. Aggressive investors could opt for large value small period SIP. Pharma is more of a long-term play and investors who can remain invested for long should only venture into this sector and deploy a buy-on-dips / SIP strategy to accumulate quality bets. Reasons for underperformance of the Pharma sector during the past two years: • Headwinds in both supply side (spike in filings/ approvals by “increased” number of players) and demand side (channel consolidation leading to fewer buyers implying pricing pressure for manufacturers); • Potential pricing probe impact in the US and appreciating INR/USD; • Overhang from increased quality compliance issues raised by the US Food & Drug Administration (USFDA) (due to higher /more scrutiny) resulting in stoppage of profitable exports of APIs and formulations from these units; • Delay in getting drug approvals; • While the Indian pharma companies feel that there is an opportunity for them due to intended abolition/dilution of Obamacare, worries that the Trump administration might get tough on issues like intellectual property rights, or invoke the Trade Facilitation and Trade Enforcement Act of 2015 to curtail imports of medicines from India are impacting sentiments.

36  September 2017

• Increased competition in the US generics market and the resulting erosion in pricing power for domestic drug makers and • Price control in the domestic market has weighed on the profitability of firms. Two Key Risks that materialized in the past two-three years: 1) Pricing Pressures in the US/Europe: Prices of drugs have fallen with rising competition and distributors buying jointly. As new companies enter US and existing ones seek to introduce more products, competition has increased, depressing prices and making it tough to maintain market share. While there is higher competition from more Indian companies in the US, Chinese firms are also increasing their presence. This increased competition has squeezed the revenues and margins of the companies. For eg, generic oral solid drugs, which fetched 40-60 per cent margins till about five years ago, now earn only 20-25 per cent. Also, the Drugs (Price Control) Order of 2013 in India which inducted a list of 348 drugs under the price control mechanism has been hurting the domestic profitability of the pharma companies as well. 2) Inspections: With India accounting for 40 per cent of US generic drug filings, FDA has over the last few years decided to ensure the drugs from India are of top quality. Inspections rose from 108 in 2009 to 290 in 2015. India has the highest number of US FDA-approved plants outside the US, with the total at 572 currently, compared with 433 in 2013. One-fifth of the FDA inspections happen in India and China currently, up from 11 per cent in 2012. FDA has also made other changes. It has cut prior intimation

time for plant inspections to as little as 24 hours from 25-30 days and inspection frequency has increased to once or even twice a year from once in two-to-three years earlier. This has highly increased the uncertainty associated with this sector, further eroding investor confidence. However, the performance of the midcap pharma players relative to the larger peers has been healthier. Revenue growth over the past five years for the mid-cap pharma firms has been higher and they have clocked faster operating profit growth of 17.18 per cent compared to large-cap firms’ 14.76 per cent. Also, while operating margins for the latter have remained constant at around 22.5 per cent over the past five years, the smaller players have exhibited a 314 bps expansion. Outlook for the sector: • Large companies remain under pressure as they await approval for complex/ niche products to take some pain off in the wake of intense competition. Small companies, which are yet to gain scale in the US, are yet to gain critical mass. Even on the domestic front, sales are expected to decline by midsingle digit for the Q1FY18 because of the disruption caused by destocking as a result of Goods and Services Tax or GST implementation. Growth in emerging markets (EMs) is expected to continue, but it is unlikely to move company revenues significantly. However, despite near term volume disruption due to GST implementation, there are structural positives on India business given the strong GDP growth, improving insurance coverage, healthcare infrastructure, etc • Improving outlook for accelerated new ANDA approvals and resolution Pharma Bio World

Market Research Trailing Return Scheme Name

Rolling Return

Inception Date

ISIN

NAV

Corpus

6 Months Absolute

1 Year CAGR

3 Years CAGR

5 Years CAGR

6 Months Absolute

1 Year CAGR

3 Years CAGR

5 Years CAGR

SBI Pharma (G)

31-Dec-04

INF200K01446

119.11

997.04

-12.12

-16.02

6.29

17.10

-2.74

-5.65

19.61

23.52

Reliance Pharma (G)

5-Jun-04

INF204K01968

121.23

1469.80

-10.81

-13.72

5.15

14.18

-1.21

-3.85

17.18

19.50

Tata India Pharma (G)

28-Dec-15

INF277K016A9

8.01

88.21

-10.07

-17.07

-3.51

-7.95

UTI-Pharma (G)

25-Aug-99

INF789F01695

79.94

325.67

-9.74

-14.33

2.98

12.53

-1.59

-4.32

13.98

17.11

-15.59

-20.15

0.66

12.00

-2.78

-6.59

13.93

18.93

S&P BSE Healthcare

Figure 1 of outstanding FDA queries while consolidation of distribution channel in the US is almost over.

which is evident from the increase in their R&D spends. Nearly half of the

• The domestic players have now started to look at the specialty drugs business with increased focus and

goes towards specialty therapies.

value by reducing cost and increasing efficiency. • US FDA inspections might prove to be a short term pain, long term gain

Moreover, new product launches in

scenario as companies will improve

specialty therapies have been higher

upon their quality standards which

importance. Specialty margins are

than in traditional therapies, due to substantial unmet needs. • Firms are evolving their model to profitably serve other regulated markets like Europe and Japan, as well as in emerging markets.

will in turn help them fare better

significantly higher and much more stable than the generic side. Typically, brand margins are 90 per cent plus, generic margins are 50 per cent or thereabout.

Leading

Indian

drug

makers such as Sun Pharma, Dr.

medical spend in the US currently

• Inorganic growth can help Indian

pharma firms access new markets and Reddy’s Laboratories, Lupin Ltd, Cipla, enhance technological capabilities in Glenmark Pharmaceuticals, Cadila Healthcare Ltd, Aurobindo Pharma developing new drugs. Collaborations Ltd, and Biocon Ltd have been making in areas such as R&D, manufacturing From out of the above four, we feel that SBI Pharma fund has been a consistent performer. investments to create such products, and marketing, can also help enhance The relative performance of SBI Pharma Fund with BSE Healthcare Index:

competitively degree

and

obtain

pricing

certain

power.

Vis-a-

vis China, Indian units will be at an advantageous position if the Chinese units are not cooperative in FDA investigations. • Local pharma policy may come in for a change, going by the pronouncements of

the

RESEARCH recently RETAIL to promote

affordable drugs. Though this could be negative if implemented with full zeal,

300 SBI Pharma Fund (G)

S&P BSE Healthcare

250

200

150

100

-50 1-Apr-11

11-Nov-11

22-Jun-12

1-Feb-13

13-Sep-13

25-Apr-14

5-Dec-14

17-Jul-15

26-Feb-16

7-Oct-16

19-May-17

Rebased to 100

Figure 2

Pharma Bio World

September 2017  37

Market Research

RETAIL RESEARCH

SBI Pharma Fund

Figure 3

RETAIL RESEARCH

the impact of this on R&D efforts in India and Make-in-India initiative may prevent any drastic negative impact on the sector. Pharma companies are solid franchisees with long term credibility. As the industry reduces its dependence on the US and creates emerging market/Rest of the world franchisees, they will become more attractive. BSE Healthcare index rose at a CAGR of 35 per cent p.a. between Mar 2009 and Mar 2015. It has later fallen -18.39 per cent in absolute terms till now. Similarly NAV of SBI Pharma fund rose at a CAGR of 39 per cent over the same period and later fell -1.28 per cent till now. There are 4 mutual fund schemes that predominantly invest in Pharma stocks. (See Figure 1) 38 ď&#x201A;&#x192; September 2017

Page |4

From out of the above four, we feel that SBI Pharma fund has been a consistent performer. The relative performance of SBI Pharma Fund with BSE Healthcare Index. (See Figure 2)

per cent in July (and hence does not figure in top 10 stocks in July 2017). The other stocks hold more or less similar weightage as of July. As on July 2017, the scheme has replaced Sun Pharma, Lupin and Glenmark with Cadila Healthcare, Thyrocare Technologies and Sequent Scientific.

The top holdings during the past one year of this scheme are: Sun Pharmaceuticals, Aurobindo Pharma Ltd, Strides Shasun Ltd, Lupin Ltd, Divis Laboratories Ltd, Cipla Ltd, Torrent Pharmaceuticals Ltd, Natco Pharma Ltd, Glenmark Pharmaceuticals and Alkem Laboratories Ltd. These stocks indicate the top holdings during the entire previous year. Out of these, the scheme has considerable reduced its exposure to Sun Pharma from 15.93 per cent in March to just 1.60

Source: Company, HDFC sec Inst Research Pharma Bio World

prevent degradation of raw materials

case study

Case Study

national products s grown dia and ous with ucts are llions of nal care

angalore ver 200 section, 2 RMS), form of g it into and the summer. the raw

ed HMX hat the C. HMX udy and ssumed perature CFM of ate even perature he ideal ine with supply 2 M. Also, ting as it obstruct

HMX-Ambiator Helps Himalaya Prevent Degradation The HMX team then executed the project keeping the ofsame Raw Materials ducting without any interference in factory working, with successful air balancing. the herbal/ayurvedic medicine in the form of

Company background

granules/powder or liquid is stored before The The Himalaya Drug Company is a leading taking it into production. This space was only result multinational medicinal drug company. It ventilated and the temperature usually soared produces health care products under the above 35°C in the summer. Generally when the The HMX-Ambiator wasItcommissioned last October and name Himalaya Herbal Healthcare. has temperature crosses 30°C, the raw material has successfully passed the lumpy 2014 summer. The grown multifold and is spread across locations turns which then has to be rejected. in India and abroad. has Today,never the Himalaya temperature crossed 28°C since then. Earlier brand synonymous with more safe andthan efficacious onisan average 2 tons of a storage capacity Theout solution herbal products; their products are prescribed of 20 tons base medicines used to invariably get by 400,000 doctors worldwide, and millions This is when the Himalaya management degraded andforrejected. This has now approached HMX forbeen its IDECtotally system. The of customers trust them their health and eliminated. requirement was that the temperature in any personal care needs. weather should not cross 30°C. HMX then carriedis out delighted a comprehensive heat load The management at Himalaya with thestudy The challenge and based on the calculated room sensible results. The store manager at the factory said “We are Himalaya’s revamped state-of-art factory in heat gain, assumed delta T of 5°C-6°C extremely satisfied of HMX units. Bangalore commenced operationwith in 2006the and performance (difference between room temperature and Earlier than 10% of raw material be is spread over more 200 acres. Its production blockthe grill temperature) it was used estimatedtothat 30,000 2, raw material section, comprises an area of rejected due to temperature spikes; dueevaporative to controlcooled of air CFM of now dual stage approximately 13,000 there ft2 (PB2is RMS), temperature zerowhere rejection.” would be adequate even in the worst condition

to ensure that the space temperature does not cross 30°C. This was re-checked with the ideal number of air changes and it was found to be in line with industry standards. Himalaya then invited HMX to supply 2 x 15,000 CFM machines totaling to 30,000 CFM. Also, Himalaya wanted to continue with the existing ducting as it was relatively new and changing the same would obstruct the factory working. The result The HMX-Ambiator was commissioned last October and has successfully passed the 2014 summer. The temperature has never crossed 28°C since then. Earlier on an average more than 2 tons out of a storage capacity of 20 tons base medicines used to invariably get degraded and rejected. This has now been totally eliminated. The management at Himalaya is delighted with the results. The store manager at the factory said “We are extremely satisfied with the performance of HMX units. Earlier more than 10% of the raw material used to be rejected due to temperature spikes; now due to control of temperature there is zero rejection.” About HMX HMX, a business unit of A.T.E., designs and manufactures unique, energy-efficient, and eco-friendly products forspace and process cooling for the industrial and commercial sectors, using its patented and highly successful DAMAtechnology. The product range includes the HMX-Ambiator, and the fresh air pre-cooling units, HMX-PCU-F and HMX-PCU-R. With an installation base of 19.5 million CFM covering more than 3.7 million ft 2. all over India, HMX is makingfast strides in providing eco-friendly cooling solutions for people and process comfort.

15000 CFM HMX-Ambiator installed at Himalaya’s Bangalore plant

15000 CFM HMX-Ambiator installed at Himalaya's Bangalore plant

Pharma Bio World

A.T.E. ENTERPRISES PRIVATE LIMITED T : +91 - 80 - 2372 1065 / 2372 2325 E : ambiator@hmx.co.in W : www.hmx.co.in / www.ateindia.com September 2017  39

marketing initiative

Fermenters

ermenters/Bioreactors plays the major role in the life science industry where they use the micro-organisms to produce valuable products like primary or secondary metabolities (vaccines, enzymes, probiotics, recombinant proteins, monoclonal anti-bodies and biosimilar) which are useful to human beings. Biotech industry/Universities use variety of fermenters at various stages like R&D, pilot and production scale fermenters

Fermenters are used to grow the living organisms/strains (bacteria, fungus) in a controlled environment where all the parameters that support the growth of micro-organisms will be provided in a closed controlled environment within the fermenter to achieve the desired product of interest. Scigenics India Pvt Ltd fabricates fermenters which are unique based on

Control Panel 40 ď&#x201A;&#x192; September 2017

customer application that fulfil customer satisfaction in terms of yield, operation and services. All their fermenters are designed as per latest standards in the market, which are user-friendly with latest available technology with LAN facility, remote operating facility, Ethernet facility, redundancy PLC to protect the process date, SCADA software to satisfy the 21 CFR compliance, and emergency alarms with auto cut-off. Based on the process requirements and level of automation Scigenics India fabricates: Automatic fermenter â&#x20AC;&#x201C; the system is designed that total fermenter operation is done through PLC/SCADA commands. All the valves and electronics are controlled through PLC with precise operation and data acquisition facility through SCADA; and

Semi-automatic fermenter - the system is designed with automation where the automation is restricted to the critical areas like jacket operation, SIP, CIP and valve operations. In this fermenter total operation can be done through PLC and data acquisition facility through SCADA. Scigenics India has successfully completed the turnkey projects which involves complete engineering (civil, structural, electrical, mechanical), supply, installation, erection and commissioning of the total project in India and abroad. Scigenis India has dedicated engineering team who are into this domain having more than 25 years of experience. Scigenics India has done more than 1,000 fermenter installations in India and abroad of various capacities in various biotech industries.

For details contact Scigenics India Pvt Ltd Plot No: H-4, 5 & 6, 3rd Cross Street Nehru Nagar, Perungudi Chennai 600 096 E-mail: Sales@scigenics.in Website: www. scigenics.in Pharma Bio World

marketing initiative

Advanced rotational control

New software package suppresses rotational sway

&R is providing a new function for crane control. Cranes that transport payloads suspended from sling sys-tems can be particularly sensitive to rotation about the vertical axis. If left unchecked, this can lead to uncon-trollable sustained oscillations. The new mapp Crane solution suppresses this rotational sway. Fast and safe payload delivery It is also possible to execute a controlled rotation, which can be helpful in cases where a payload needs to be positioned at a specific angle. With simultaneous control of both pendulum and rotational oscillation, payloads can be brought to their destination with maximum speed and precision.

mapp Crane actively controls rotation about the vertical axis to prevent unwanted rotational oscillation.

B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.

About B&R B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation,

For details contact B&R Industrial B&R Industrial Automation B&R Strasse 1, 5142 Eggelsberg, Austria t +43 7748 6586-0 press@br-automation.com www.br-automation.com.

Automatic path correction mapp Crane also offers automatic path correction, which adjusts for changes to the end position while the crane is in motion. This is an especially challenging task with regard to path planning, because the recalcula-tions must account for the systemâ&#x20AC;&#x2122;s oscillation dynamics in addition to its axis boundaries. With mapp Crane, this function can now be implemented with very little programming.

mapp Crane actively controls rotation about the vertical axis to prevent unwanted rotational oscillation. Pharma Bio World

September 2017 ď&#x201A;&#x201E; 41

marketing initiative

Two operating systems on one device

B&R is introducing a hypervisor for its automation system

&R is introducing a hypervisor there is a reserved memory area that is a single device and communicate with for its automation system. This not assigned to either operating system. each other via a virtual network. software allows Windows or Linux About B&R to run alongside B&Râ&#x20AC;&#x2122;s own real-time Maximum flexibility B&R is an innovative automation operating system. That enables you to combine the control and HMI applica- The user configures the hypervisor company with headquarters in Austria tions on a single PC, for example, or and allocates hardware resources and offices all around the world. On have an industrial PC double as both in the B&R Automation Studio soft- July 6, 2017, B&R became a business a real-time controller and an edge ware development environment. The unit of the ABB Group. As a global controller that sends preprocessed data configurations are defined separately leader in industrial automation, B&R to higher level systems and the cloud for each system, providing maxi-mum combines state-of-the-art technology flexibility in how resources are utilized. with advanced engineering to provide via OPC UA. Whereas previous parallelization customers in virtually every industry solutions were tailored to a specific with complete solutions for machine and Virtual network Windows version, B&Râ&#x20AC;&#x2122;s hypervisor factory automation, motion control, HMI The hypervisor provides a virtual network is completely independent of which and integrated safety technology. With Industrial IoT communication standards connection that allows applications operating systems are used. like OPC UA, POWERLINK and to exchange data between operating openSAFETY as well as the powerful systems. Like with the usual Ethernet interface, this is done using standard The B&R hypervisor allows multiple Automation Studio software development B&R is constantly network protocols. In place of a cable, operating systems to run in parallel on environment, redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial automation is driven by a commitment to simplifying processes and exceeding customer expectations.

The B&R hypervisor allows multiple operating systems to run in parallel on a single device and communicate with each other via a virtual network. 42 ď&#x201A;&#x192; September 2017

For details contact B&R Industrial B&R Industrial Automation B&R Strasse 1, 5142 Eggelsberg, Austria t +43 7748 6586-0 press@br-automation.com www.br-automation.com. Pharma Bio World

marketing initiative

HRS technology for Mega Food Parks & food processing sector showcased at Anutec International Foodtec 2017, Delhi

RS Process Systems Ltd. (HRS PSL), part of HRS Group, UK, participated in Anutec International Foodtec 2017 organized by Koelnmesse India from 21st to 23rd August 2017 at Pragati Maidan, New Delhi. The company exhibited its innovative range of heat exchangers and food processing systems for fruit pulp, juice, beverage processing, dairy & nutraceutical processing sectors and other process industries. Mr. V Gokuldas, Managing Director, HRS Process Systems Ltd said, “The start of Food Parks and Mega Food Parks announced by MoFPI (Ministry of Food Processing Industries) has enabled many prospective processors to invest and give further boost to the food processing sector in India. HRS is one of the most trusted names in food processing equipment segment with globally accepted technology trusted by food and beverage giants. This credibility has enabled HRS bag some key turnkey projects for fruit pulp, juice & beverage. Mega Food Parks are looking forward to advanced technology for global competitiveness and HRS plays a key role in processing technology. We have commissioned one Mega Food park near Pune for processing of fruits and working on another in Andhra Pradesh. We are executing a special Mega Food park in Chhattisgarh for processing of fruits and vegetables. International Foodtec 2017 organized by Koelnmesse was a good platform to update customers and industry at large with our efficient and sustainable solutions. Our application engineering and solutions have been well appreciated by Customers. We are committed to our Customers for quality product, performance satisfaction and efficient service.” HRS’ heat transfer and processing solutions like the HRS Monobloc Aseptic Steriliser cum Filler, single & multiple effect evaporation systems, HRS ParaDice* dice pasteurizer, juice & beverage processing systems, UHT systems for dairy and nutraceutical

Pharma Bio World

processing systems were detailed at the event to the visitors. The heart of these systems is the flagship heat exchanger Ecoflux* Corrugated Tube Heat Exchangers (CTHE), and also HRS Funke Plate Heat Exchangers (PHE), Unicus scraped surface heat exchanger, Hygienic Piston Pump and similar range of products which enable continuous processing, retention of nutritive value, better quality and shelf life of the end product. These systems have been developed for a range of applications for fruits such as mango, tomato, guava, pomegranate, citrus fruits such as orange, sweet lime, banana, papaya, and many more. HRS also caters to processing technology for sensitive dairy products & infant food products show cased at the exhibition. This event took place along with three other co-located events Packex 2017, Sweet & Snacktec 2017 and Dairy Universe 2017. HRS’ clients and some of the well-known companies such as Mother Dairy, Pepsico, ITC Foods, Haldiram Foods, Jadli Foods, Devraja Foods visited this exhibition. About HRS PSL: HRS Process Systems Ltd (HRS PSL), India, is part of the UK based HRS International group of companies, a prestigious name in the field of innovative heat transfer solutions.

HRS Group is globally recognized for providing sustainable, energy efficient range of heat exchangers and heat exchanger based systems. In India since year 2003, HRS PSL has built its repu¬tation in value-added engineering, manufacturing excellence and customer service. The company is ISO 9001:2008 certified with over a decade of experience in supplying state-of-the-art solutions for heating, cooling, pasteurizing, sterilization, evaporation and aseptic processing of various fruit pulps/ beverages for the food/fruit/beverage industry. HRS also offers heat transfer solutions across a wide spectrum of other industries like pharmaceu¬ticals, chemical, fertilizer, agrochemical, textile, edible oil & fats, paper & pulp, oil & gas, steel, power, effluent treatment, automotive etc. Their innovative products include ECOFLUX* corrugated tube heat exchanger, UNICUS® Scrapped surface heat exchangers, HRS Funke plate heat exchanger, HRS Piston Pump, HRS ParaDice* dice pasteurizer, Aseptic Fillers, Integrated systems for food processing and evaporators. For details contact HRS Process Systems Ltd 201/202 Karan Selene, 851 Bhandarkar Instt Rd, Pune - 411004. Tel: 020 25663581/82/ 66047894 Email: info@hrsasia.co.in Web: www.hrsasia.co.in September 2017  43

press release Piramal Pharma Solutions Names John Fowler as its Chief Operating Officer Piramal Pharma Solutions (PPS), part of Piramal Enterprises Limited, announce the appointment of John Fowler as its Chief Operating Officer. PPS is a leader in Integrated Contract Development and Manufacturing, with a global network of 12 development and manufacturing facilities across North America, Europe and Asia. PPS offers a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies and Commercial supply of APIs and Finished dosage forms. As Chief Operating Officer, John will be responsible for Global Operations and Research & Development (R&D), and will play a lead role in ensuring that our customers consistently experience differentiated and excellent levels of service. Most recently, John served as the Divisional CEO of the Global Fine Chemicals business at Johnson Matthey (JM), with responsibility for JM’s Services (Custom API Development, Manufacturing, Catalyst & Chiral Technologies), and Products (Generics Development and Manufacturing) portfolio. Before leading JM’s Fine Chemical Division, John held senior leadership roles in several business verticals at JM, including Pharmaceutical Materials and Services, Environmental Catalysts and Technologies, among others. John has a Chemical Engineering degree from Bucknell University and an MBA from St. Joseph University.

Aurigene and Curis Announce CA-170 Program Update Aurigene Discovery Technologies Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, announced plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India. This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc, a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial. CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treat-

44  September 2017

ment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses. Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.

SCHOTT Integrates Big Data Solution into Pharma Tubing Production SCHOTT has recently integrated a specially developed big data solution into its pharmaceutical tubing production in India, replacing statistical sample-based quality assurance with 100 percent on-line measurement. With the new IT-based process called perfeXion, process- and product-quality data of each individual glass tube is collected online and in real-time – an innovation that sets new standards in the pharmaceutical glass industry. During the multi-layered process of pharmaceutical tubing production, statistical quality control is not 100% thorough. However, thanks to a unique big data approach, SCHOTT Glass India is now able to measure 100% of every single glass tube in production. Instead of selecting a few glass tubes from each batch for statistical quality control, the new perfeXion system measures the entire glass tube many times over as it is drawn from the melt. Lasers recognize deviations in diameter and wall thickness, for example, and camera and IR inspection systems can even detect the smallest inclusions in the glass. Around 100,000 data tags are generated every minute. An integrated IT system, evaluating the continuous glass tube with real-time data measurements, calculates incidents of imperfection with such precision that it can later differentiate corresponding individual tubes which can then be sorted out. Each tube is checked again at its completion. The system’s development took several years. Analyzing a curved tube surface zooming down a production line was a particularly difficult challenge. The effort, however, has paid off – not least because the data analysis is a source of insight into how production can be further optimized. Pharma Bio World

press release Align National TB Strategies with Commitment to End TB by 2030: WHO World Health Organization has called on countries in South-East Asia Region to build on recent momentum aimed at ending TB by 2030, commending their resolve to take action and urging all countries to review and align national plans with the Delhi Call to Action. “The Region-wide momentum established to ‘bend the curve’ and end TB by 2030 is laudable. The Delhi Call for Action, issued by health ministers in March, demonstrates high-level awareness that business as usual is not enough, and that intensified efforts are needed. We have reached a critical consensus; the pressing need now is to translate commitment into action,” Dr Khetrapal Singh, Regional Director, WHO South-East Asia, said. Across the Region, TB remains the largest cause of death and suffering due to any communicable disease among the most productive age groups. Although the Region accounts for approximately one quarter of the world’s population, it has nearly half the number of new TB cases and close to 40% of TB deaths globally. In recognition of TB’s outsized burden, accelerating progress towards the 2030 target – which requires a 90% reduction in TB deaths and 80% decrease in TB incidence – is now one of WHO South-East Asia Region’s Flagship Priority Areas of work. As a critical first step in implementing recent commitments, Dr Khetrapal Singh emphasized the need for countries to align national plans with the 2030 target. “By reviewing and amending national TB plans countries will enhance their ability to mobilize and utilize resources efficiently. Good planning is key to establishing the foundations for success,” she said.

Merck to Join Forces with Project Data Sphere Merck, a leading science and technology company has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck’s Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain. The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, Pharma Bio World

and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

IIL Forays into Herbal Market with ‘Zuspray’ Hyderabad-based Indian Immunological Limited (IIL), a leading player in human and animal health has launched its first herbal product ‘Zuspray’ for animals. The launch of this herbal topical spray marks IIL’s entry into the Rs 480 crores valued domestic animal health herbal market. The herbal ingredients in ‘Zuspray’ will help in the treatment of all types of open wounds including surgical wounds. IIL has forayed into the herbal market with Zuspray. This will expand IIL’s target market by a diversification strategy of entering into the herbal market. In the coming years IIL will plan to enrich their portfolio with few more products related to animal health care particularly the productivity of the animal. Zuspray is a reliable wound healer for all animals. The product will be available in 100 ml spray bottles across all retail shops in India which caters to animal health products.

Dr. Reddy’s Launches USP (XL) in the US Market Dr. Reddy’s Laboratories Ltd. announced that it has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, a therapeutic equivalent generic version of Wellbutrin XL (Bupropion Hydrochloride Extended-Release) Tablets, approved by the US Food & Drug Administration (USFDA). The Wellbutrin XL brand and generic had US sales of approximately USD 754 million MAT for the most recent twelve months ending in July 2017 according to IMS Health. Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, are each available in bottle count sizes of 30, 90 and 500. Wellbutrin XL is a trademark of GlaxoSmithKline LLC. September 2017  45

Compact Vacuum Packages

Hybrid - LRVP Toshniwal, leaders in vacuum engineering for over 70 years, now provide further solutions to your vacuum needs. Pompetravainiâ&#x20AC;&#x2122;s the most advanced manufacturing technology in liquid ring vacuum pump has now created as improved liquid ring pump that offer optimum performance and reliability. They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extending its life even under harsh condition. Pompetravaini has the most advanced manufacturing process is with the objective to reduce manufacturing times and shortening delivery times.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Toshniwal provides solution to your vacuum application, provide solution to your vacuum application, replace multi-stage water/liquid ring pumps, and steam jet ejectors with compact vacuum packages. The volume flow is from 180 to 97,000-m 3/hr. Energy savings resulting from low motor rating. Integral pipe work allows easier installation. Constant vacuum is in the range 0.1 to 400-mbar (absolute). Booster and rotary pump may be started at the same time. Built-in bypass value to protect from overloads.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilapuk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net

Liquid Ring Vacuum Pumps Toshniwal leader in vacuum engineering provides further solution to your vacuum needs in manufacturing of liquid ring vacuum pumps that offer optimum performance and reliability. They offer minimal water consumption and an innovative impeller design that assure extremely quite operation and extends its life even under harsh condition the most advanced manufacturing process with the objective to reduce manufacturing and delivery time. Hydrotwin, PLC controlled roots + LRVP package for high vacuum application with total liquid recirculation capacity to 3,900-m 3/hr and max vacuum 2-mbar. Hydrosys, centralized package vacuum units with total or partial water recirculation capacity to 3,500-m 3/hr and max vacuum 33-mbar. It finds application in distillation, drying, material transfer, power and steel, food processing, paper, general vacuum and textile. For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26445626, 26448983 E-mail: sales@toshniwal.net

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Smooth-Surface Motors The new permanent-magnet synchronous motors without cooling fins achieve level IE4 / super premium efficiency. This can greatly benefit the food, beverage and pharma industries, and other hygienically demanding applications. The efficient smooth-surface motors are suitable for use in dry areas as well as in applications requiring frequent cleaning. As they generate very little excess heat, they need no fans and therefore do not contribute to the spreading of germs. The IE4 or Super Premium Efficiency synchronous motors operate significantly more efficiently than induction motors, specifically in the partial load range. This results in substantially lower cost for energy consumption and lower TCO. The motors furthermore feature a particularly high power density and a very long product life. Frequency inverters can be mounted directly onto the motor or near the motor for perfect flexibility. Three motor sizes (80, 90 and 100) with power ratings from 0.75 to 2.2 kW are available. They complement the existing smooth-surface induction motor range, which already covers outputs from 0.37 to 1.1 kW. The motors can be supplied with a brake. For washdownenabled inverter-controlled drive systems with an IP66/IP69K protection rating, NORD can draw on four different suitable gearbox series. Wash-down drive configurations all feature die-cast aluminum housings with smooth surfaces, designed so that cleaning fluids and foams easily run off. For extra corrosion protection, they can be fitted with the nsd tupH Sealed Surface Conversion System, which is approved for food and drink applications in accordance with FDA Title 21 CFR 175.300. For more information, please contact:

NORD Drivesystems Pvt Ltd 282/2, 283/2, Village Mann Tal. Mulshi, Adj. Hinjewadi MIDC II Pune, Maharashtra 411 057 E-mail: Muthusekkar@nord.com / marketing.in@nord.com

Platinum Cured Silicone Hose Reinforced with SS 316 Helical Wire Imavac is platinum cured silicone hose reinforced with SS 316L helical wire. It has better transparency to visualize flow and kink resistance. Imavac is designed for material transfer application under high vacuum in pharma industries. The product is more superior compared to Imafit in high pressure and high vacuum rating applications. It is also used for anti-static application. Imavac conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI, and ISO 10993-1. It is certified by ROHS and TSE/BSE Certification (free of animal derived material), free of restricted heavy metals. It is free of Phthalate/Bisphenol/ Volatile Plasticizer. It has US FDA DMF accreditation #26201. Complete validation package available upon request.Imavac has high burst pressure resistance compared to Imafit. It is designed for high vacuum rating applications. It has anti-static properties to dissipate static electrical charge makes it suitable for highly volatile flammable fluid transfer. It imparts no taste and odour. It is lot traceable. Its temperature range is -80°C to 180°C. It is available with SS-316 L TriClover end. It is sterilizable by Autoclave, Ethylene Oxide Gas & Gamma Radiation. For more information, please contact:

Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E), Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

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Multi-mill Oil Lubricated Vacuum Pumps Toshniwal supplies oil lubricated vacuum pumps. These oil lubricated vacuum pumps of the TMS Series are single stage, oil-lubricated rotary vane vacuum pumps with oil re-circulation system. Pumping capacity ranges from 15-m 3 /hr, 35-m 3 /hr, 65-m 3 /hr and 100- m 3 /hr. TMS Series pumps has economical features which matches together to achieve high pumping speed over the range of absolute pressure of 1,000-mbar to 0.5-mbar; high water vapour tolerance and low noise level; air-cooled; and built-in anti-suck back system. Designed for continuous operation at high intake pressure the pump is used in various applications like pick and place, packaging, degassing, low boil distillation, solvent recovery, heat treatment, bottle filling, vacuum drying, etc. Toshniwal also provide special B Series oil lubricated pump for high pressure (rough vacuum) application upon request.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448983, 26448558 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

GC/Q-TOF System Agilent Technologies Inc offers a new high-resolution, accurate-mass system designed for laboratories doing food and environmental testing, life science research, forensics and chemical analysis. The Agilent 7250 GC/G-TOF system combines gas chromatography and quadrupole time-of-flight mass spectrometry with a Low Energy Electron Ionization source that enables greater exploration of unknown chemical samples. The new system represents the only commercially available combination of a high-resolution, accurate-mass GC/MS and lowenergy ionization source, making it possible for scientists to employ analytical techniques that were not previously practical or in some cases even possible. The capabilities of the 7250 GC/Q-TOF system will now allow labs to quickly and easily identify volatile and semi-volatile compounds that, in the past, would require them to perform alternative techniques or longer sample preparations to detect and determine the compounds present in their samples. Furthermore, with Low Energy Electron Ionization, scientists will be better able to elucidate chemical structures. Agilent offers a range of GC/MS technologies for both qualitative and quantitative analysis across a wide variety of applications.

For more information, please contact: Agilent Technologies Inc 5301 Stevens Creek Blvd Santa Clara, CA 95051, U.S.A. Tel: +1 408 553 2005, +45 29 33 69 80 E-mail: victoria.wadsworth-hansen@agilent.com

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Triplex Series Pumps

Density Meter The DIMF Series density / concentration meter is based on the oscillating element principle. Major applications are process control and quality monitoring of fluids in all areas of industry. The device can also be used for density mass flow conversion for custody transfer in connection with the corresponding volumetric meters and flow computers. Features direct measurement of density, reference density or concentration; long service life and high reliability due to the very robust construction; very high long-term stability; highest accuracy/repeatability; maintenancefree; measuring element suitable for CIP and SIP,self-draining (Type 2.0); independent of mounting position; and no deadzones and gaskets. For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-2644 8558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

Mouvex offers the integration of Finder Triplex Series pumps into its growing portfolio of transfer solutions for the energy and industrial markets. Triplex Series pumps are highly reliable reciprocating plunger pumps specifically designed for a wide variety of critical applications found in oil and gas (onshore and offshore), nuclear and general industrial industries. These pumps are also compliant with API 674 to provide the best in reliability and safety. Triplex Series pumps are available in seven models – TD18, NF50, NH77, NJ116, NL171, TN 260 and TP420 – with power rating ranging from 13 to 310 kW (18 to 420 HP). Typical applications include water jetting, methanol injection, glycol recirculation, descaling, boiler feeding, and others.

For more information, please contact: Dover India Pvt Ltd – PSG 40 Poonamallee By-pass, Sanneerkuppam Chennai 600 056 Tel: 044-26271020, 26271023 E-mail: sales.psgindia@psgdover.com

Mass Flow Controller The mass flow meters and controllers consist of a metal body with a straight throughflow path. Two sensors are encased with stainless steel and protrude inside this bore; one is designed as a heater and the other one is designed as a temperature probe. The working principle is based on King’s law of the ratio between the mass flow and the heater energy, which means, the higher the flow, the more energy is required to maintain the chosen. Features direct inline measurement principle; useable for virtually every kind of gas or gas-mix; mass flow measurement and control for a wide scope of applications; compact and robust design; IP65 for full product range; sensor made of stainless steel; no inlet pipe required; measurement without moving parts; customised adjustable multi-functional display: actual flow, totaliser with memory and reset alarm, setup and much more. For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-2644 8558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

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Check Weigher

Cage Blender Cage blender is available in standard cGMP and customized models with SS 304/316/316L contact parts. It is mainly used for blending of dry powders for tablet production and capsule, facilitating better flow for tablets and capsules. Totally dust-free operation and adaptable to handle more than one container, equipped with advanced control systems and modern PLC with manual operating system. Available in batch capacities ranging from 50 to 1,500 kg as per client’s requirements, depend on bulk density. For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC, Ankleshwar Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

Check weigher CW 600HSA uses the state-of-the-art technology weigh cells (EMFC) to achieve greater accuracy in dynamic weighing at high speed. The system provides 100 per cent online weighing, ensuring compliance with international standards of pharma, food, chemical and cosmetic industries. Check weigher CW 600HSA also improves production line profitability through significant reduction in product-give-away. The entire system is made from SS and designed for easy removal for cleaning purpose. It finds application in pharma – mono cartons, vials, ointment tubes, etc; food – snack food, spices, chemicals, agro chemicals, dairy, confectionary, glass/HDPE bottle, etc. For more information, please contact:

Technofour Electronics Pvt Ltd Gat No: 3 (PT), 5 (PT), 243 (PT) Kasurdi (Kheba) Khed Shivapur-Saswad Road Post: Khed Shivapur,Tal: Bhor, Dist: Pune Maharashtra 412 205 Tel: 02113-305200, 305246, Fax: 91-02113-305250 E-mail: pcssales@tepl.co.in / teplinbox@gmail.com

Vacuum Dryers Vacuum dryers are widely used in the industry for drying in variety of products. Vacuum dryers are batch dryers ideal for drying of heat sensitive products, drying of products in solvents (for subsequent solvent recovery), drying requirements necessitating achievement of very low moisture or low oxygen drying environments to minimise oxidation or for explosion-prone products. AVM offers customised vacuum drying systems with variety of configuration: In agitated cylindrical vacuum dryer, heat is supplied to jacket of stationary cylindrical housing. The material to be dried is kept in agitation by means of specially designed rotor. In double cone vacuum dryer, heat is supplied to double conical shaped rotating jacket. The material to be dried is kept in continuous tumbling within the rotating housing. Conical shape facilitates easy drain-out of material at the end of the batch. For more information, please contact:

New AVM Systech Pvt Ltd AVM House, 3B+3 Part, 1/3, Akurdi Indl Estate Opp: Ador-Welding Ltd, D-1 Block, MIDC, Chinchwad Pune, Maharashtra 411 019 Tel: 020-27459986, 27459987 Fax: 91-020-27459988 E-mail: avmtechnologies@vsnl.net

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NGS Target Enrichment Solution Agilent Technologies Inc offers it’s newest next-generation sequencing (NGS) library prep solution - Agilent SureSelect XT HS a complete target enrichment research solution that provides total workflow management for laboratories, from QC to target enrichment, to analysis and interpretation. SureSelect XT HS is a streamlined, high-sensitivity (HS) solution for research, optimized for labs with a requirement to sequence DNA from formalin-fixed paraffin-embedded (FFPE) samples, which may have degraded over time. By incorporating molecular barcodes, SureSelect XT HS improves overall precision and produces higher complexity libraries than competing products, on a broad range of tissue types and low- and high-quality FFPE samples. SureSelect XT HS libraries, with higher percentage reads in targeted regions, require as little as 10 ng of starting DNA, and use molecular barcodes to assist error correction. Additionally, faster and more efficient processing with master-mixed reagents that require less hands-on time, coupled with a 90-minute hybridization - the most rapid hybridization on the market - enables labs to now move from sample to sequencer in a single day. For more information, please contact: Agilent Technologies Inc 5301 Stevens Creek Blvd Santa Clara, CA 95051, U.SA. Tel: +1 781 266 2819 E-mail: naomi.goumillout@agilent.com

Leak Detector Edwards offers the new ELD500 precision leak detector. It is designed for fast, accurate leak detection and is customisable for any application. Edwards’ ELD500 is ready to go in under two minutes from power On. Users can benefit from simple pass/fail readings through to detailed analysis via the easy to read control interface, and due to the low weight and integrated carry handles it is mobile enough to be bench top or trolley mounted. At the push of a button the ELD500 can easily be set to work in either vacuum mode for precise measurement of leak rate or sniffer mode for identifying the leak location. The proven design of Edwards’ ELD500 leak detector, combined with low energy consumption, extended warranty and even longer life ion source, ensures exceptional low cost of ownership with no compromise on performance. Edwards’ ELD500 achieves excellent repeatable accuracy through calibration with the integrated test leak source and high quality mass spectrometer, so it could be used on a production line, where consistent measurement repeatability is critical or in a laboratory environment where typically the measurement of extremely low leak rates is needed. The ELD500 has three variants, the FLEX, WET and DRY plus an extensive catalogue of accessories. For more information, please contact:

Edwards Ltd Innovation Drive, Burgess Hill West Sussex RH15 9TW, U.K. Tel: +44 (0) 1293 52 88 44 E-mail: rebecca.walder@edwardsvacuum.com pr@edwardsvacuum.com

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Coating Pan

Strip Packing Machine Strip packing machine is designed to handle a wide range of products with almost precision and speed up to 2,400 units per minute. It finds usage in pharma, engineering and industrial product sectors; machine is most suitable for heat sealable foils.

For more information, please contact:

Pharma Chem Machineries 311/2484, Motilal Nagar No: 2 M G Road, Goregaon (W) Mumbai 400 090 Telefax: 01-022-28735321 E-mail: pharmach@gmail.com / pharmachem79@gmail.com

Available in different sizes from 300 to 1,800 mm dia SS pan, polishing pan can be interchanged with coating pan. The unit can be supplied with hot air blower system of suitable capacity, with electrical or steam heating system.

For more information, please contact: Pharma Chem Machineries 311/2484, Motilal Nagar No: 2, M G Road Goregaon (W), Mumbai 400 090 Tellefax: 91-022-28735321 E-mail: pharmach@gmail.com pharmachem79@gmail.com

Flat Dry Disconnect Coupler and Adaptor OPW Engineered Systems offers it’s new Kamvalok flat dry disconnect coupler and adaptor. Engineered with all the same industry-leading features and benefits as traditional OPW Kamvaloks, the major technological advancement in the Kamvalok Flat is the incorporation of flattened connection points, including patent-pending smooth, flat-face poppets. This design effectively eliminates all cavities where liquid can pool and subsequently spill upon disconnection, reducing up to 85% of fluid loss at disconnect. OPW Kamvalok dry disconnect couplers are ideal in liquid-transfer applications involving a variety of chemicals such as petroleum products, solvents, paint, lacquers, inks, adhesives, fatty acids, pharma, soaps, detergents, agrochemicals, caustics and many acids, to name a few. They feature easy-toclose stainless-steel Autolok locking arms and an industry-standard stainless-steel locking handle, which secures both the opened and closed positions to prevent accidental release or uncoupling. The Autolok locking arms also provide added protection with an automatic locking mechanism that is signaled by an audible, positive click, whereas uncoupling requires only an easy tug on the lock release. In addition, Kamvaloks feature vibration-resistant Twin-Kam arms. The OPW Kamvalok Flat is available in aluminum and stainless steel, and offered in 1.5-, 2-, and 3-inch sizes. A variety of temperature ranges are also available.

For more information, please contact:

Dover India Pvt Ltd – PSG 40 Poonamallee By-pass, Sanneerkuppam, Chennai 600 056 Tel: 044-26271020, 26271023 E-mail: sales.psgindia@psgdover.com

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Zero Hold-up Filter Press In reverse flow zero hold up type, the direction of flow of liquid is exactly opposite to the flow in standard filter, ie, the impure liquid to be filtered enters the filter from the bottom into the center channel and goes to the top of each plate. The clear filterate flows out from openings on side of plates to the shell and then to the outlet. This flow ensures almost 100 per cent filtration of the liquid. Complete filtration of the batch without any hold up due to reverse flow of liquid hence large saving in time and cost. Backwash facility can be provided for continuous operations. No scavenger arrangement required.The cake, filteraid and solids remain totally enclosed allowing filtration of toxic, hazardous and explosive liquids. The top dome structure ensures fast and easy removal of cartridge assembly and cleaning of cake.

For more information, please contact:

Brilliant Process Machinery Pvt Ltd Unit No: 1, 2, 14 Mordan Indl Estate Opp: Ipol, Waliv Phata, Vasai (E), Dist: Thane Maharashtra 401 208 Tel: 0250-3293636 E-mail: brilliantprocess@rediffmail.com

Dry Disconnect Couplings OPW Engineered Systems offers it’s new Twist-Lok dry disconnect coupler. With its user-friendly operation and simple handling, the new Twist-Lok provides a quick, easy connection with minimal product loss. Representing the latest addition to OPW’s industry-leading range of dry disconnect couplings, the Twist-Lok has been specifically designed to be fully interchangeable with other dry disconnect couplers in the marketplace. The Twist-Lok has also been manufactured in accordance with the NATO STANAG 3756 Standard, and features SS316 construction and an integral heavy-duty swivel to aid connection and minimize hose wear. In addition, this new coupler is designed with unique safety features for the operator, such as the ability to be fully interlocked when connected, while it includes a locking mechanism in the open position. Product selectivity is also available via mechanical keying to minimize risk of cross-contamination. Twist-Lok couplers are offered in 1-, 2-, 3- and 4-inch sizes (with larger sizes available upon request) and are available with a range of seal materials, including fluorocarbon, EPDM and FFKM with FNPT and ANSI flanged connections. The Twist-Lok is available with pressure ratings up to 360 psi, making it ideal for LPG and other high-pressure applications. It is also suitable for vacuum service, and meets or exceeds all European and American railcar approvals.

For more information, please contact:

Dover India Pvt Ltd – PSG 40 Poonamallee By-pass, Sanneerkuppam, Chennai 600 056 Tel: 044-26271020, 26271023 E-mail: sales.psgindia@psgdover.com

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Rapid Mixer Granulator This type of granulator is used extensively in pharma industries. The machines have a SS mixing bowl containing a three-bladed main impeller, which revolves in the horizontal plane, and a three-bladed auxiliary chopper (breaker blade) which revolves either in the vertical or the horizontal plane. For more information, please contact:

Kunal Machines 104 Kothari Indl Estate Next to Asian Paints, LBS Marg, Bhandup (W), Mumbai 400 078 Tel: 022-61271111, 67251949 E-mail: kunalmachines@gmail.com

Vibro Shifter This machine is specially developed by separation of solids from solids, liquids from solids and gradation of materials in accordance with their sizes which has always presented problems, specially when large quantity of material is to be processed.

For more information, please contact: Pharma Chem Machineries 311/2484 Motilal Nagar No: 2 M G Road, Goregaon (W), Mumbai 400 090 Telefax: 91-022-28735321 E-mail: pharmach@gmail.com

Producing WFI Using Membrane Processes Bosch offers its new system for the production of water for injection (WFI). WFI is used in solutions for injection and infusion, making it a key component in pharma manufacturing. However, the revised European Medicine Agency (EMA) Pharmacopeia allows, for the first time, WFI to be obtained using other comparable processes. The generation unit employs the “cold” membrane processing methods reverse osmosis and electrodeionization, together with an additional ultrafiltration step. Reverse osmosis is a physical filtration process that removes ions from the water, and the subsequent electrodeionization further reduces the remaining salt content through a combination of ion exchange and electrodialysis. The unit’s ultrafiltration module then separates out particles such as microbes and pyrogens on the basis of their weight and molecular size. Essentially, the unit must produce water under conditions that prevent the growth of microorganisms and other impurities. For reverse osmosis systems, the EMA stipulates regular sanitization of the unit using hot water – primarily to prevent the formation of biofilms. Biofilms are caused by microbes, such as bacteria, and are difficult to remove from industrial systems. For additional protection, chemical sanitization must also be an option. Total organic carbon (TOC) is a key indicator of the water’s quality, and since it is also a parameter for the risk of microbial contamination in the overall system, it has to be continually monitored. Conductivity is another important parameter, and here the EMA stipulates inline process control. The unit is equipped with an online measuring system to monitor specific conductivity. In order to routinely test the water in real time, Bosch has also installed an online microbe counter, which continuously records and quantifies the level of microbes and inert particles using light-induced fluorescence measurements and algorithms. All parameters are centrally monitored and controlled by means of an intuitive interface. For more information, please contact:

Commha Consulting Poststraße 48, D-69115 Heidelberg, Germany Tel: +49 6221 18779-23, Fax: +49 6221 18779-11 E-mail: mark.haverkamp@commhaconsulting.com

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Pharma Bio World

Die-cut Strip Packaging Siebler unites heat-sealing technology with die-cut packaging formats. Formats for both standard and individual-shaped strips can be produced using Romaco Siebler heat-sealing technology. The Siebler HM 1 machines can be configured to manufacture die-cut strips at the customer’s request. Individual-shaped strips can be designed entirely according to each Romaco customer’s requirements. There are no limits to the possible geometries. With integral grooves as opening aids, the heat-sealing technology unites design with functionality. Bespoke strip perforation patterns are also no problem. The unique primary packaging helps strengthen the product’s brand personality. To enable individual-shaped strips to be manufactured, a heat-sealing machine belonging to the Romaco Siebler HM 1-350 series is equipped with a continuous cutting station. Two servo-driven punches cut strips out of the foil layer with a drawing cut. Nothing more is needed to create air, light and moisture-tight unit dose packaging with an individual design. Several specimen sealing pattern options are likewise available. Any machine configured for die-cutting individual-shaped strips can also be used to make standard strip formats. All in all, the Romaco Siebler HM 1-350 is capable of delivering up to 900 individual-shaped strips per minute. Choosing the right heat-sealing foil is crucial in order to produce strip packaging efficiently and reliably. The machinability of a foil in relation to the speed at which it is to be processed is always the decisive factor. This calls for a detailed analysis of the sealing parameters, so that the processes and features of the heat-sealing machine can be adapted accordingly. The aim is to achieve packaging which remains absolutely tight in any circumstances. All packaging must pass various stability tests before it is approved by the pharma regulatory authorities for a particular product. For more information, please contact: The Romaco Group Am Heegwald 11, 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Aluminium Lidding Foil A premium grade lidding foil is manufactured with high quality inspection. ACG Pharmapack offers ALUMLID, a premium grade lidding foil for thermoform, coil form and tropical blisters. The foil exhibits exceptional sealability of sealing layer made of PVC, PVdC, polyethylene and propylene. ALUMLID is made from validated raw material sources that are compliant to the global regulatory standards of the pharma market. The foil serves as ultra high barrier packaging solution assuring utmost product protection and an enhanced shelf life. ALUMLID is a cost-effective lidding foil that runs smoothly on all blister packaging machines ensuring high production efficiency. For more information, please contact: ACG Pharmapack Pvt Ltd SciTech Centre, 7 Prabhat Nagar Jogeshwari (W), Mumbai 400 102 Tel: 022-30462832 E-mail: sales@acg-weld.com

Pharma Bio World

September 2017  55

events diary                

                                                                      

                                                                                 

      

    

  

       

           

                                                                                                              

                                                                 



     

    

56  September 2017

Pharma Bio World

bookshelf Vaccines and Autoimmunity (Hardcover) Authors: Yehuda Shoenfeld, Nancy Agmon-Levin, Lucija Tomljenovic (Editors) Price: USD 110.80 No of Pages: 384 pages In light of the discovery of Autoimmune Syndrome Induced by Adjuvants, or ASIA, Vaccines and Autoimmunityexplores the role of adjuvants – specifically aluminum in different vaccines – and how they can induce diverse autoimmune clinical manifestations in genetically prone individuals. Vaccines and Autoimmunity is divided into three sections; the first contextualizes the role of adjuvants in the framework of autoimmunity, covering the mechanism of action of adjuvants, experimental models of adjuvant induced autoimmune diseases, infections as adjuvants, the Gulf War Syndrome, sick-building syndrome (SBS), safe vaccines, toll-like receptors, TLRS in vaccines, pesticides as adjuvants, oil as adjuvant, mercury, aluminum and autoimmunity. The following section reviews literature on vaccines that have induced autoimmune conditions such as MMR and HBV, among others. The final section covers diseases in which vaccines were known to be the solicitor – for instance, systemic lupus erythematosus – and whether it can be induced by vaccines for MMR, HBV, HCV, and others.Edited by leaders in the field, Vaccines and Autoimmunity is an invaluable resource for advanced students and researchers working in pathogenic and epidemiological studies.

History of Vaccine Development (Hardcover) Author: Stanley A Plotkin (Editor) Price: USD 201.97 No of Pages: 349 pages Vaccinology, the concept of a science ranging from the study of immunology to the development and distribution of vaccines, was a word invented by Jonas Salk. This book covers the history of the methodological progress in vaccine development and to the social and ethical issues raised by vaccination. Chapters include “Jenner and the Vaccination against Smallpox,” “Viral Vaccines,” and “Ethical and Social Aspects of vaccines.” Contributing authors include pioneers in the field, such as Samuel L. Katz and Hilary Koprowski. This history of vaccines is relatively short and many of its protagonists are still alive. This book was written by some of the chief actors in the drama whose subject matter is the conquest of epidemic disease.

Advanced Vaccine Research: Methods for the Decade of Vaccines (Hardcover) Authors: Fabio Bagnoli, Rino Rappuoli (Editors) Price: USD 360.00 No of Pages: 484 pages Since the publication of Fabio Bagnoli’s and Rino Rappuoli’s first book in 2011 (Vaccine Design: Innovative Approaches and Novel Strategies; ISBN 978 1 904455 74 5), the field of vaccinology has advanced significantly. The application of new sophisticated ‘omics’ technologies and the use of pioneering approaches have yielded a wealth of new data. This new book distills the most important new findings to provide a timely overview of the field. Written by leading experts in the field, each chapter affords a critical insight to a particular topic, reviews current research, discusses future direction, and aims to stimulate discussion. The provision of extensive reference sections in the book’s chapters positively encourages readers to pursue the subject in greater detail. The book has retained the format of the 2011 book and is divided into two main parts. The first section explores in considerable depth the key innovations that are dramatically changing the field, both for preclinical as well as clinical vaccine research fields. Pharma Bio World

September 2017  57

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Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use. Quality assurance is a good practice in the manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet the standard for the proposed use. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability. Quality is a benchmark of perfection for the end-user. In the October issue of Pharma Bio World, we intend to cover views of industry honchos that address trends, issues, opportunities and challenges pertaining to Quality Assurance. To ensure Pharma Bio World continues to meet your needs, we would appreciate your feedback. Please feel free to write to us at mahesh_kallayil@jasubhai.com if you think we can serve you better.

58  September 2017

Pharma Bio World

                                   

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