Single Use & Disposable Technology in Biomanufacturing

Single Use &Disposable Technology in Biomanufacturing Industry Overview Pharma IQ Sector Report & Resources June 2011 In Association With Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Contents 3. Single Use Technologies Changing the Biomanufacturing Landscape 5. In Demand: Prefilled Syringes 6. FDA publishes guidelines on H1N1 diagnostics tests 7. Creating new disposable solutions in Biomanufacturing 9. Economic Analysis of Single Use Tangential Flow Filtration for Biopharmaceutical Applications (White Paper) 10. Additional Resources 11. Disposable Solution Online 2011Authors: Andrea Charles | Tim Haidar | Helen Winsor | Richard DeSilvaPharma IQ 2010 - 2011 Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ ReportSingle Use Technologies Changing the BiomanufacturingLandscape by Eric Langer During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and running. Now, single use products have pushed beyond an early-stage technology, and are poised to emerge into the much larger, GMP commercial-scale operations. The emergence of single use devices onto the commercial stage is likely to create radical changes in the biomanufacturing landscape. Key to this is first to resolve safety issues associated with leachables and extractables. Comparability with existing processes (stainless steel) will result in more rapid adoption rates. The needs in single use technologies that will assure GMP operations—and biomanufacturers’ applications and integration of them--have driven end-users to demand vendors put R&D efforts into these devices. In fact, according to BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production[1], single use devices top the list of key areas where biomanufacturers want to see product development. Source: 8th Annual Report and Survey of Biopharmaceutical Manufacturing; Preliminary data, pub April 2011; BioPlan Associates, Inc. http://www.bioplanassociates.com/ These responses for where new products are being demanded reflect both the growing acceptance of disposable/single-use devices, and the growing need for better systems. Nearly 39% of the industry wants vendor innovation in basic single-use devices, suggesting significant opportunities for companies with inventive R&D initiatives and product development capabilities. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ ReportThe need for more effective, standardised single use equipment is generally felt by both vendorsand end-users. Improvement is most strongly called for in "extractables and leachables” whichleads the list in “Reasons for Restricting Use of Single-Use Devices”, cited by 74% of 2011respondents (up from 68% in 2010). These data suggest an opportunity for vendors with R&Dthat delivers better materials. Both significant levels of innovation and incremental changes areneeded to spark improvements that facilitate use of single use devices. Survey respondentsindicated the following as specific areas in need of improvement:• Simplifying change-over and cleaning operations• Reducing overall capital investments• Reducing risks of product cross-contamination• Speeding up time to get facility up and running• Improving campaign turnaround times• Standardising devices to avoid costs of system modifications• More ‘modular’ approaches• Reducing space requirements• Improving assurance of sterility• Decreasing documentation requirements; simplify QA/QC• Improving sterile-sampling• Simplifying overall operations to reduce learning curve for new operators• Improving control of bioreactors• Reducing the need for operations staff• Improving strength and reliability—to reduce bag breakageSuch solutions will require innovative leadership, process documentation, and training thatdemonstrate how devices can be effectively integrated into operations. In fact, industry expertsbelieve process simplification will be the real driver for single use success. Single use vendorsare likely to see profitable opportunities when they go beyond the current new product strategy ofsimply replacing stainless steel with plastics.Hand-in-hand with innovation will be the need for standardisation of the currently-proliferated,unique designs and devices. “While there is a huge amount of specific activity, we believe thefuture of single-use technologies will include higher levels of integrity and quality, supply chainsecurity, faster delivery to customers and global material and specification standards for fasterimplementation,” says Doug Neugold, CEO, ATMI.To get to the next level of growth and efficiency will likely require a more ‘plug-and-play’ deviceapproach guiding product design and innovation. This kind of standardisation will also permitgreater efficiency and lower costs. Thus, to get beyond the current steady rate of adoption,innovation may focus on making production easier for people with fewer skills, on a globalperspective.[1] 8th Annual Report and Survey of Biopharmaceutical Manufacturing, Preliminary Data,Publication Date April, 2011, BioPlan Associates, Inc. www.bioplanassociates.comWhat do you think? Leave your feedback here Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ ReportIn Demand: Prefilled Syringes The prefilled syringes sector has witnessed healthy growth in recent years and demand is expected to rise. This is due to the increased number of injectable biological drugs in the pipeline and healthcare professionals and patients demanding safer more convenient drugs, devices and delivery systems. According to a recent iRAP report, PH-1 Nano-Enabled Packaging for the Pharmaceutical Industry—A Global Technology, Industry and Market Analysis: “Global demand for prefillable inhalers and prefilled syringes will generate the fastest growth opportunities among all pharmaceutical packaging products, based on performance advantages in drug delivery and the introduction of new bioengineered medicines.” Advantages of prefilled syringes A prefilled syringe is a single–dose packet of a parenteral drug attached to a needle by the manufacturer, although traditionally used for vaccines and blood stimulants, they are now used in a wide range of therapeutic areas. The main advantage when compared to single glass vials is their ease of use. The user does not need to withdraw the required amount of vial from a vial before using the syringe. By removing this step, prefilled syringes provide a safer more convenient way for health professionals and patients to administer injectable drugs. Prefilled syringes reduce human error and administer drugs with a higher degree of accuracy because of this their popularity in the medical community continues to rise. It is not surprising that many pharmaceutical companies are adopting prefilled syringes as their preferred way to deliver injectable drugs. In an article for OndrugDelivery entitled Unilife – Developing Prefilled Products of Choice, Stephen Allen, Vice President of Marketing and Communications at Unilife said: “More than 20 pharmaceutical manufacturers are using prefilled syringes as a preferred delivery device for over 50 injectable drugs and vaccines that have a total combined annual sales of approximately US$ 50 billion.” Increased demand to throw away Originally made of metal and glass, we are now seeing developments in disposable prefilled syringes. In recent years, there has been a shift from glass to plastic syringes, due to advances in materials construction and manufacturing processes. Innovation in prefilled syringes and injection devices has also been spurred on by a demand for disposable medical supplies on a global scale. Recent outbreaks of the H1N1 virus and a rise in nosocomial infections have pushed Infection prevention and vaccine administration safety up the agenda. The Freedonia Group predicts in the Disposable Medical Supplies report,thatUS demand for disposable medical supplies will increase 4.1 per cent annually to more than $79 billion in 2013. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ Report "Demand will also gain upward momentum as hospitals, outpatient facilities and other health care establishments adopt stricter safeguards to meet infection prevention standards,” said the report. Injectable biotherapeutics on the rise- The prefilled syringes sector is also set to grow as the use of biologics increases and the number of injectable biotherapeutics coming onto the market is rising. The demand for prefilled syringes and other injection devices is high and many contract manufacturers are taking advantage of this opportunity. Earlier this year AMRI acquired Hyaluron for $27m (€22m) to enter the prefilled syringe contract manufacturer sector and expand the customer base for its existing operations.FDA publishes guidelines on H1N1 diagnostics tests The U.S. Food and Drug Administration has released guidelines for manufacturers developing diagnostic tests for the 2009 H1N1 influenza virus. The Secretary for the Department of Health and Human Services declared a national public health emergency last April. Manufacturers are now able to submit requests to the FDA for an emergency use authorization (EUA) for the test. The guideline provides advice on exactly what information these requests should include. During such a period of emergency, EUA provides the right for the FDA to sanction the use of uncleared or unapproved medical supplies and the use of these materials, provided that specific criteria has been met. The FDA recognizes that manufacturers may not be able to produce full data of any clinical validation normally related in premarket applications, but the new guideline offers suggestions for fundamental facts, such as safety, effectiveness and careful interpretation of trial results. A recent approval by the Administration to allow the expansion of a flu vaccine produced by Australia’s CSL Ltd. to children over the age of 6 months, was achieved through an accelerated approval regulation. Analysis was undertaken of the company’s seasonal antibody-inducing vaccine in order to begin its distribution in the U.S. as a measure of protection from the life- threatening disease. The FDA also had to issue statements of assurance in the wake of doctors voicing concerns over the limited trials of the vaccine. Commissioner Dr. Margaret Hamburg has expressed her understanding of such anxiety, but confirmed safety has and continues to be closely monitored, a stance so far reinforced by the lack of adverse effects found in clinical trials of 3600 patients. Meanwhile, manufacturers are finding the need to push for more efficient processes in developing vaccines for current and future pandemics. U.S. based Novavax, a company developing a recombinant vaccine for H1N1, teamed with GE Healthcare to further the use of disposable vaccine manufacturing systems based on GEs portfolio of single-use systems, and more recently with Xcellerex, also known for its innovative disposable technology. The aim is to avoid the extensive downtime accrued from the sterilization process required on older, stainless steel biomanufacturing equipment, which in large-scale operations can struggle to meet the need for rapid response. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ ReportCreating new disposable solutions in Biomanufacturing The cost-savings which disposable biomanufacturing systems can bring are well known, but the problem for many organisations is how to take full advantage of these. A key consideration for companies is how to generate savings in all areas of development and manufacturing, as this can help to maximise both the efficiency and output of facilities. One organisation which recognises the importance of this is ATMI, which recently announced it has acquired the Belgian biotechnology firm Artelis SA, a specialist the field of highly-efficient bioprocesses and technologies for cell culture research and manufacturing scale-up. According to ATMI, the acquisition complements its work in ultra-pure single-use films, bioreactors and mixing systems for characterising, developing, and manufacturing biopharmaceuticals, as well as extends its global capabilities to a "broad range" of biopharmaceutical process expertise. In the last four years, the two firms have partnered to develop technologies that address the rising demand for disposables in the life sciences research and manufacturing sector. ATMI was an early investor in Artelis and this latest transaction has seen it acquire the remaining equity position in the Brussels-based firm. Doug Neugold, ATMI chief executive officer and president, said Artelis is an "innovator and leader" in cell culture process optimisation for vaccine, veterinary and cell therapy applications. He added: "This acquisition integrates those capabilities with ATMIs industry leading - and in many instances enabling - single-use mixing and bioreactor technologies." "Our combined capabilities make us an even stronger partner for our customers, as they look for innovation to support their objectives of getting drugs to market more quickly and in the most efficient way." Jose Castillo, president of Artelis, said that the firms customers will obtain the "immediate benefit" of ATMIs global presence. He pointed to ATMIs has state-of-the-art manufacturing operations in both Europe and North America, which he claims is an "important consideration" for companies who rely on suppliers for critical, single-use products. In addition, ATMI also has project management, supply chain and quality assurance expertise, as well as established distribution channels which are demanded by customers, the expert added. As part of the transaction, the Artelis executive team have assumed new roles within ATMI LifeSciences, while researchers and scientists working at Artelis will continue their cell culture research and development as part of ATMI LifeSciences R&D team. Mario Philips, senior vice president and general manager of ATMI LifeSciences, said Artelis represents a "compelling strategic" fit for the company and expands its commitment to the life sciences market. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Pharma IQ ReportWhile still at an early stage from a commercial ramp standpoint, the close collaboration withcustomers and "world-class results" in cell line development and cell culture technology allowthem to provide the biopharmaceutical sector with comprehensive single-use solutions andtechnical support, he noted.Speaking to in-PharmaTechnologist shortly after the acquisition, he said the key motivation forthe acquisition was to "create more value for customers by going beyond the traditional valueproposition of disposables".The need for a more flexible and reactive bioprocessing approach has been well publicised inrecent years, with the H1N1 outbreak and its industry response notable examples, but there aresome kinks in the chain that need to be addressed when it comes to issues such as thevalidation and integration of single-use systems.Mr Philips acknowledged that there is still work to do, but added that the companys aim is to"bring high-purity and ultra-clean products to a level of breadth and depth not seen before in thelife sciences market".He noted that both firms can help support the development of human and animal vaccines,monoclonal antibodies and cell therapy applications.Companies are finally beginning to recognise that money can be saved, yields increased and thatdisposables are more environmentally sound, the expert argued."This shift in attitude is taking place as a result of the now proven benefits of single-use systems,highlighting budding growth of this new disposable manufacturing industry," he concluded.As these benefits become more well-known, the importance of devising a long-term, globalstrategy to maximise the economy and flexibility of disposable biomanufacturing systems andspeed time to market will only continue to grow in the months ahead. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

White PaperEconomic Analysis of Single Use Tangential Flow Filtrationfor Biopharmaceutical Applications Tangential flow filtration (TFF) is a common processing step in concentration and diafiltration (buffer exchange) operations in the downstream processing of biopharmaceutical products. Using a pre-sanitised, disposable TFF membrane makes it possible to reduce the number of process steps and thus reduce labor by 50% or more and reduce buffer and water usage by 75% or more. In addition to the cost savings realised from the reduced labor and buffer usage, single use TFF can increase productivity, by >45% in many cases. This article outlines an economic model for comparing the costs of reusable and single?use TFF in biopharmaceutical applications. By Michael LaBreck, global product manager for TangenX technology, and Mark Perreault, director of membrane application development for TangenX technology, both at Novasep. Download Here Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Additional ResourcesINTERVIEWAssessing the Impact of Single-Use Biomanufacturing SystemsWith Dr. Kit Erlebach, Head of Technical Commercial Manufacturing at Avecia,and Tony Hitchcock, Head of Process Science at Cobra Biomanufacturing Whilst single-use systems have brought many advantages for bioprocessing, such as accelerated downtime and reduced costs, there are still some challenges that need to be addressed. Dr. Kit Erlebach, Head of Technical Commercial Manufacturing at Avecia, and Tony Hitchcock, Head of Process Science at Cobra Biomanufacturing, discuss new single-use technologies in the industry. They examine the potential of these designs over the coming decade, assessing the environmental impact, the ability to respond to emergency outbreaks, and the means by which companies can introduce products into their existing facilities.INTERVIEWTransforming Biomanufacturing with Single-Use SystemsWith Jerold Martin, Sr. V.P., Global Scientific Affairs, Biopharmaceuticals, Pall Life Sciences In this interview Jerold Martin, Sr. V.P., Global Scientific Affairs, Biopharmaceuticals, Pall Life Sciences and Chairman of the Board and Technology Committee at the BPSA, speaks to Andrea Charles from Pharma IQ, about future trends for Single-Use biomanufacturing and the advantages of Single-Use systems for biomanufacturing. Martin also shares his experiences regarding what factors to consider when implementing a Single-Use technology and their environmental impact.INTERVIEWA Comparative Analysis of Single-Use Bioreactors – The ResultsWith Aurore Poles Lahille, New Technologies and Manufacturing Support at Merck Serono Aurore Poles Lahille, Assistant Scientist and Specialist in New Technologies and Manufacturing Support at Merck Serono Biodevelopment, joins Helen Winsor from Pharma IQ, to discuss a comparative analysis of single use bioreactors and understanding the most effective implementation. Poles begins with an overview of the comparative study – the rationale, challenges and results, before talking about the criteria used to assess whether the SUB is right for a particular system and the best integration approaches. Disposable & Single Use Technology Pharma IQ Sector Report & Resources 2011

Devise a Long-Term, Global Strategy to Maximise Economy and Flexibility of Disposable Biomanufacturing Systems and Speed Time to Market GlossaryBe part of the worlds first online single use summit Event HighlightsRecent reports indicate that the market for disposables has been growing at 30% a year for the past few How it Worksyears, which can be attributed to many things, primarily the huge cost-saving potential. Agenda FAQ’sWith speed and flexibility also at the top of the priority list when it comes to biomanufacturing, it’s clear Check out thewhy single use systems have seen such growth in recent years. However, streamlining your Early Bird Sale!!biomanufacturing facilities, managing suppliers and achieving operational excellence are all still areaswhere much change and improvement is needed. Meet Your SpeakersDo you have a strategic approach to implementing disposables or are you new to single use Pricingsystems? Register TodayPharma IQ brings you an exciting industry first - Disposable Solutions for Biomanufacturing Online, which takes placeacross September 2011. This is a truly global event, allowing us to bringing together the international biomanufacturingand regulatory community in a dedicated forum to help you implement an effective single use systems strategy.This interactive online event will bring together an international panel of thought leaders to discuss and debate theopportunities and challenges that single use systems present for the biomanufacturing industry – all of this in a convenientonline format.What Would you Ask the FDA? Heres your chance to hear directly from Ingrid Markovic, Expert review Scientist, CDER,FDA and ask any burning questions! Ingrid is a resident expert on extractable and leachable studies and will be sharing herknowledge on developing a risk based testing programme and the regulatory expectations are - get approval FIRST TIME!This 100% online event begins September 6 and runs through to September 28, 2011.In order to accommodate your schedule, we have spread this event over the course of a month so that you may attend atyour convenience. Simply log in to 2 sessions, twice a week. Presentations will also be available on-demand so if you missa session, you will always have an opportunity to catch up at a time that is convenient! Be sure to secure your spot on the only single use system focused online summit - Best practice guide to assessing the cost saving benefits of single use vs. fixed systemsHighlights - A first hand overview on disposable systems regulatory requirements from FDA - Establishing an effective supplier qualification process - Successfully implementing the next steps to a global, industrial manufacturing scale using single use systems - A compare and contrast study of different bioreactors from Merck Serono - Applying QbD principles to disposable biomanufacturing - Disposing of your disposables - efficient and sustainable waste management strategies Disposable & Single Use Technology Meet the Speakers Pharma IQ Sector Report & Resources 2011

Single Use & Disposable Technology in Biomanufacturing

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