2 BioProcess International 10(8) September 2012

Volume 10 Number 8 September 2012

Issue Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4From the Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Editorial Advisory Board . . . . . . . . . . . . . . . . . . . . . . 6Awards Spotlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Focus on . . . The Regs . Creating a Corporate Compliance Program: What You Cannot Afford to Miss . . . . . . . . . . . . . . . . . . . . . . . . . . 14 David Restaino and Leslie Gladstone Restaino

Quality . QbD for Biologics: Learning from the Product Development and Realization (A-MAb) Case Study and the FDA OBP Pilot Program . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Steve Koslowski, Wassim Nashabeh, Mark Schenerman, Howard Anderson, Ilse Blumentals, Kowid Ho, Rohin Mahtre, Barbara Rellahan, and Victor Vinci, with Lorna McLeod

special RepoRtLegacies in Bioprocessing: Freezing and Thawing Progress Over Time . . . . . . . . . . . . .30 Ellen M . Martin

technical aRticlesProduction of a Viral-Vectored Vaccine Candidate Against Tuberculosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46 Ingo Jordan, Nigel Woods, Gary Whale, and Volker Sandig

Novel Single-Use Sensors for Online Measurement of Glucose: Use with Online DO and pH Monitoring . . . . . . .56 Irina Bauer, Iris Possendorf, Stefan Spichiger, Ursula E . Spichiger-Keller, and Gernot Thomas John

VendoR VoiceAdvancements in Processing That Optimize Samples for Future Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Andy Brooks and Aleks Davis

Global Marketplace . . . . . . . . . . . . . . . . . . . . . . . . . .70Global Meetingplace . . . . . . . . . . . . . . . . . . . . . . . . .72BPI BioMall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74Index of Advertisers . . . . . . . . . . . . . . . . . . . . . . . . . .74

elucidationHow an Obscure Asian Rodent Took Over Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76 Ellen M . Martin

Read more about the articles and themes in this issue on page 4.

oN the CoVerA fermentation suite worker at AstraZeneca’s Alderley, UK, facility illustrates this month’s production theme. (www.aStrazeneca.com)

editorial offiCeS SaleS aNd admiNiStratiVe offiCeS1574 Coburg Rd . #242 Eugene, OR 97401 editors@bioprocessintl .com

Submit manuscripts at www .editorialmanager .com/biop

Editor in Chief S. Anne Montgomery amontgomery@bioprocessintl .com (article and supplement queries, editorial policies)

Senior Technical Editor Cheryl Scott cscott@bioprocessintl .com (press releases, art submissions, design)

Managing Editor Maribel Rios mrios@bioprocessintl .com (article queries, special projects)

Find BPI citations online in the Chemical Abstracts Database (www.cas.org).

One Research Drive, Suite 400A Westborough, MA 01581 (sales inquiries, media kits, advertising)

Publisher and Interim Western Regional Sales Manager Brian Caine 1-508-614-1443 bcaine@bioprocessintl .com

Eastern Regional Sales Manager Christopher Johnson 1-508-614-1273 cjohnson@bioprocessintl .com

European Sales Manager Mary Jane Riddell 44-(0)-20-7017-4218 maryjane .riddell@informa .com

Sales and Marketing Coordinator Kim Rafferty 1-508-614-1226 krafferty@bioprocessintl .com

Production and Creative Manager Yusef Ramelize 1-212-520-2715 yusef .ramelize@informausa .com

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Marketing Manager Damon Mastandrea 1-212-520-2739 damon .mastandrea@informausa .com

List Rental Amy Miller 1-508-614-1251 amiller@ibcusa .com

Reprints Rhonda Brown 1-800-382-0808 rhondab@fosterprinting .com

©2012 BioProcess International (USPS 0022-044, ISSN 1542-6319) is published eleven times a year by Informa Life Sciences Group at 52 Vanderbilt Ave ., New York, NY 10017, Phone: 1-212-520-2777, fax 1-212-661-5052, www .bioprocessintl .com . Periodicals postage is paid in Westborough, MA and additional mailing offices . POSTMASTER: Send address changes to BioProcess International, PO Box 1170, Skokie, IL 60076 . Canadian publication agreement No . 41067503 . Canadian return address DPGM 7496 Bath Road Unit 2, Mississauga, ON L4T 1L2 . Electronic subscriptions are available online . Articles are abstracted by the Chemical Abstracts database at www .cas .org .

For subscription inquiries, call 1-847-763-4930, toll free 1-877-232-2399, or email bioprocess@halldata.com.

4 BioProcess International 10(8) September 2012

iN thiS iSSueFocus on The Regs“Regulatory compliance” is an evolving concept that must adapt to each company’s unique business climate as well as changing regulatory circumstances . Standard operating procedures are just the beginning . Compliance requires thought in creating a code of conduct and in setting up a process to allow for internal complaints — and to test a company’s success and failure rates . As the Restainos describe on page 14, anything less is doomed, and in a worst-case scenario, will encourage fraud and severely threaten a company’s reputation and financial bottom-line .

Focus on QualityFor the third time, the CASSS CMC Strategy Forum focused on the topic of quality by design (QbD) for biologics in July 2010 . As discussed on page 18, presentations and discussions detailed implementation strategies and key practical QbD elements that are readily achievable in the short-term . In addition, the forum examined key learnings from two important QbD Industry-FDA collaborations: the A-MAb case study and the FDA OBP pilot program .

Special Report: Bioprocess LegaciesData, computer systems, people and expertise, corporate history resulting in best practices, products — it is hard enough to maintain continuity of records and practices over time in probably any industry . But in a highly regulated industry, maintaining such knowledge is essential throughout every product’s lifetime . On page 30, Ellen Martin describes characteristics that freeze some key biotechnology industry legacies in place . How do companies make improved or next-generation versions of sometimes very old products using very new technologies? How can they move into the future without weakening their own historical foundations? What forces and decisions can help “thaw” processes that may be frozen in outmoded practices?

Viral Vector ProductionTo make a less costly tuberculosis vaccine that can be made more widely available than those currently on the market, the Oxford-Emergent Tuberculosis Consortium and Emergent Biosolutions engaged the help of a contract manufacturer . On page 47, authors from ProBioGen describe development of a scalable manufacturing process incorporating a novel avian cell line . They used disposable technologies suitable for high-capacity and low-cost production .

PAT for Online Glucose MeasurementProcess analytical tools exist to support innovation and efficiency in pharmaceutical development . The FDA encourages manufacturers to use a PAT framework for

development, manufacturing, and quality assurance . On page 56, authors from two sensor companies collaborate with an academic to described a possible response to the requirement of systems that can analyze and control a critical cultivation parameter (glucose) using real-time process measurements .

Optimizing Samples for Future ResearchMany factors contribute to the quality of biospecimen collections . How a company can assess the value of a clinical or preclinical biosample at the time of collection may be very different than at the time of analysis, which can be and often is a distant-future event . To help ensure the quality of such specimens Andrew Brooks and Aleks Davis suggest on page 62 some general sample life-cycle management principles that can retain the maximum value of any collection .

A Brief History of CHO CellsIn support of this month’s special report, on page 76 Ellen Martin provides an in-depth look at one special legacy in bioprocessing: the Chinese hamster ovary cell lines that dominate production of complex, glycosylated proteins for biotherapeutic use .

Production

Special Report: Bioprocess Legacies

6 BioProcess International 10(8) September 2012

from the editor

A nother successful BioProcess Theater at the Biotechnology Industry Organization’s annual BIO Conference and Exposition (Boston, MA) led BPI into the

summer on a high note . In fact, a number of our presentations this past June attracted standing-room–only audiences in the exhibit hall’s BioProcess Zone, with steady attendance throughout the three days of the event .

The BioProcess Theater creates a forum for discussion of technologies and applications for both exhibit-hall–only attendees and full-conference registrants . Presenters enjoy long conversations afterward with attendees, and we are always delighted to see those discussions continuing on the “periphery .” BPI continues to enjoy a productive collaboration with BIO’s event organizers to manage the logistics of this forum (this year enabling us to record the presentations) — and we are already planning for our 2013 program .

Roundtables: This year, three panel discussions on Monday afternoon (18 June 2012) offered insights on building biomanufacturing in emerging markets (chaired by Stephen Flavin, provost of Worcester Polytechnic Institute); CGMP operational excellence and infrastructure harmonization from laboratory to plant (chaired by John Helfrich, vice president of GMP automation programs at Accelrys); and regulatory and technical advances toward biosimilar development (chaired by Charles Squires, vice president of discovery and partnerships at Pfenex) .

On Tuesday (19 June 2012) BPI’s publisher, Brian Caine, chaired a panel that continued the discussion from BPI’s single-use supplement article on the potential for standardization of disposables . Representing some major suppliers of single-use technologies/components, panelists fielded practical questions from the audience, indentifying the pros and cons of standardization, how it might or might not happen, and whether it could hamper still-needed innovations in materials and supply chain management . When vendor representatives such as these can step outside their individual product lines to address common concerns, the audience and industry benefits tremendously . We are grateful to Jerry Martin (Pall Corporation’s senior vice president of public affairs), Jeffery Craig (director of global marketing and North American sales for ATMI Life Sciences), Paul Priebe (FMT director at Sartorius

Members of the BioProcess International Editorial Advisory board volunteer their time to advise the editors about industry trends, technologies, potential authors, and topics of interest. They review all technical manuscripts, and their recommendations help the editors make final publication decisions. Members of the advisory board are not expected to endorse any products, technologies, or companies mentioned; the editors refrain from soliciting reviews from any advisor for whom such a conflict of interest may be involved.

Siddharth Advant, Senior Director CMC Project Management, ImClone Systems, Branchburg, NJ, USA

Hazel Aranha, Head of Virus Safety, Catalent Pharma Solutions, Raleigh RTP, NC, USA

Milton J. Axley, Fellow, Process Biochemistry, MedImmune LLC, Gaithersburg, MD, USA

R. Lee Buckler, Managing Director, The Cell Therapy Group, Bellingham, WA (USA) and Vancouver, BC (Canada)

Michel Chartrain, Distinguished Senior Investigator, Merck and Co ., Rahway, NJ, USA

Nancy Chew, Principal Consultant, Regulatory Affairs North America LLC, Durham, NC, USA

Laurel Donahue-Hjelle, Director of Cell Line Development, Invitrogen Corp ., Rockville, MD, USA

John J. Dougherty, Regulatory Scientist, Eli Lilly & Company, Indianapolis, IN, USA

Don R. Durham, Consultant, Durham Consulting LLC, Chapel Hill, NC

Jim Faulkner, Vice President, CMC Manufacturing and Supply, Rare Diseases, GlaxoSmithKline R&D, Brentford, UK

Pete Gagnon, Chief Scientific Officer, Validated Biosystems, Inc ., Singapore

Hélène Gazzano-Santoro, Director, Analytical Development and Quality Control, Genentech (Roche) South San Francisco, CA, USA

Rick Hancock, President, Althea Technologies, Inc ., San Diego, CA, USA

Timothy K. Hayes, Vice President, Analytical Chemistry, Quality and Regulatory Affairs, ProMetic BioTherapeutics Inc ., Gaithersburg, MD, USA

Kenneth Hughes, President, Roker Biotechnologies, Inc ., Toronto, ON, Canada

Susan Dana Jones, Senior Consultant, BioProcess Technology Consultants, Acton, MA, USA

Alex D. Kanarek, Senior Consultant, BioProcess Technology Consultants, Acton, MA, USA

Dennis M. Kraichely, Associate Director and CMC Team Leader, Johnson & Johnson Pharmaceutical R&D, Malvern, PA, USA

Vadim Klyushnichenko, First Vice President, Preclinical Services and Process Development, Paragon Bioservices, Inc ., Baltimore, MD, USA

Fred Mann, Program Manager, Downstream Process Solutions, Millipore Corporation Billerica, MA, USA

Adriana E. Manzi, Managing Director, Atheln, Inc., San Diego, CA, USA

Otto-Wilhelm Merten, Gene Therapy Program, Généthon II, Evry, France

Thomas J. Pritchett, Senior Consultant, Quality Services Consulting, Palm Desert, CA, USA

T. Shantha Raju, Assistant Director, Centocor Inc ., Radnor, PA, USA

Nadine M. Ritter, Senior Consultant, Biologics Consulting Group, Alexandria, VA, USA

Sally Seaver, President, Seaver Associates LLC, Concord, MA, USA

Robert P. Shaw, Program Director, Millipore Corporation, Billerica, MA, USA

Abhinav Shukla, Vice President of Process Development, KBI Biopharma, Raleigh-Durham, NC, USA

Michiel Ultee, Chief Scientific Officer, Laureate Pharma, Princeton, NJ, USA

Scott M. Wheelwright, President, Strategic Manufacturing Worldwide SMW Biotech, Saratoga, CA, USA

William G. Whitford, Senior Manager, Bioprocessing Market Thermo Fisher Scientific, Logan UT, USA

Shuichi Yamamoto, Professor, Process Design and Engineering Laboratory, Graduate School of Medicine, Yamaguchi University, Tokiwadai, Japan

Jianguo Yang, Principal Scientist and Senior Manager, Commercial Cell Culture Development, Genzyme Corp ., Framingham, MA, USA

Xiaoming (Jerry) Yang, Scientific Director, Process and Product Development, Amgen Inc ., Thousand Oaks, CA, USA

editorial adViSorS (peer-reView board)continued on page 12

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8 BioProcess International 10(8) September 2012

SpotlightThermo Fisher Hosts a Series of BioProcessing Seminars by Maribel Rios

Thermo Fisher Scientific wrapped up its North American series of BioProcessing Technology Seminars in June 2012 in North Carolina . Over two months, the company and local biomanufacturers hosted six all-day events at different venues focusing on cell culture media design, single-use systems, bioreactor technologies, and performance optimization . Agendas included interactive presentations from industry experts and typically ended with a tour of a local bioprocessing facility .

On 21 June in Cambridge, MA, Eric Langer (BioPlan Associates) kicked off the fifth meeting in the series by reviewing the current state of cell culture processing and of the biopharmaceutical industry in general . Results of his company’s 9th Annual Report and Survey of Biopharmaceutical Manufacturing indicated that the industry is growing at a pace of 15–18%, fueled by higher expression titers and growing interest in biosimilars/biobetters . “Outsourcing has increased overall but is slowing,” said Langer . Investments have increased, with “the most prominent of vendor investments in process and product development .” That emphasis on performance has created a greater need for training so that companies can focus on productivity without further straining their already limited budgets for travel to conferences and seminars .

Ann Pisania (Acceleron) started the technical portion of the seminar with a discussion of her company’s implementation of single-use technologies . After reviewing the capabilities of clinical manufacturing and pilot-production facilities, she pointed out real-world examples of challenges with some (earlier) single-use bioreactors, including bag failure . The company now uses stirred-tank disposable bioreactors to “obtain tighter control of the process and allow for more straightforward transfer” to contract manufacturers . She also reviewed Acceleron’s other experiences with single-use systems, including obstacles that were surmounted before implementation .

Leland Paul (CMC Biologics) presented case studies demonstrating the advantages of single-use technologies at 50-L to 2,000-L capacities: single-use mixers, upstream seed trains, single-use bioreactors, and harvest (depth-filter) systems . Some related issues companies have had to address for cell culture, said Paul, include bag placement, leaks, and poor growth in seed-train culture bags . His case studies reviewed lessons learned and benefits from using single-use technology platforms, especially disposable bioreactors .

Thermo Fisher Scientific’s Millie Ullah then spoke of “next-generation” single-use systems that address manufacturing needs for greater flexibility, faster turnaround times between product campaigns, and reduced set-up times . Elaborating on Langer’s point regarding the industry’s increased emphasis on product performance, she demonstrated how advances in single-use bioreactors are meeting high-titer demands .

Currently, most sites that use disposable components or systems are “hybrid” facilities, a combination of traditional stainless-steel equipment and disposable units . Andrew Sinclair (BioPharm Services) reviewed

hybrid systems for cell culture, focusing on costs associated with scale-up and scale-out . His examples included configurations for facilities using multiple 1,000-L or 2,000-L bioreactors and configurations for pooling bioreactor harvests .

Wesley D . Marner (Applikon) concluded the meeting by reviewing control equipment for disposable bioreactor systems . Considerations for selecting a controller platform include equipment layout and configuration as well as control hardware, sensors, and actuators . A good bioprocessing strategy, said

Marner, ensures that all such considerations lead to an integration of one “single-use concept .”

The North American seminar series ended with similar presentations in Raleigh, NC . Earlier venues were in Bellevue, WA; Los Angeles, CA; Foster City, CA; and King of Prussia, PA . Thermo Fisher Scientific is hosting a two-day European seminar on 6–7 November in Frankfurt, Germany . That event will feature speakers from BioPlan Associates, BioPharm Services, CMC Biologics, Crucell, Cobra Biologics, Applikon, and Thermo Fisher Scientific . For more information (and to register), visit http://events .SignUp4 .com/eu-seminar-2012 .

A Decade of Animal Cell Culture by Cheryl Scott

Eukaryotic cells are fragile and finicky, requiring very specific culture conditions and nutrients to survive, grow, and be productive in ex vivo environments . Even so, they are vital to the biopharmaceutical industry’s ability to make complex biological products — having overtaken yeast as a production system around 1990 and surpassing bacteria in the number of associated product approvals five years later (1) .

Since then, animal cell culture has become even more useful, expanding its reach into the vaccine world . Mammalian cell lines can express correctly formed proteins with complicated posttranslational modifications that are essential to their biological function . And the baculovirus expression vector system (BEVS) for transient protein expression by insect cells

— well established in laboratory settings but slow to be adopted in bioprocessing — has come into its own as a vaccine production system . New vaccines such as those for human papilloma virus are made using the BEVS, and influenza vaccine makers are transitioning from egg-based production to mammalian cell culture (2) . Transient expression as a concept has even begun to see use with mammalian cells, too .

Cell Line Engineering: A decade ago, a commonly discussed topic at industry conferences was a manufacturing capacity crunch that was predicted around the turn of the century . Biopharmaceutical manufacturers (especially those using mammalian cell culture to make antibody products) were projecting market demands that their existing facilities and processes could never meet . Many potential solutions were discussed, among them transgenic production options . But amazing scientific and technological advancements led to animal cell lines and culture systems that could make a lot more protein within the space available . It wasn’t long before we were reporting on those results and an averted crisis .

Using technology such as the Genetix automated ClonePix system (now from Molecular Devices), cell line engineering took mammalian cell protein expression titers from hundreds of milligrams to several grams per liter of culture through a number of mechanisms (3) . These include special promoter genes, enhancer elements, polyadenylation sequences, introns, chromatin modifiers and insulators, and internal ribosome entry

sites, all used to improve transcription efficiency (3) . Selection markers help developers identify the most stable cells that have fully integrated the expression cassette (gene sequence) into their own genomes . Resulting cell lines may then be adapted to grow and thrive in culture media that have necessary properties for commercialization (4) .

Media and Supplements: As early as its second published issue, BPI was helping to make the case for serum-free media in biopharmaceutical production (5) . Eliminating animal-based products from culture feeds provides several advantages in bioprocessing: defined composition, reduced contamination risk, and lower costs . But serum-free, animal-free, protein-free, and chemically defined media present their own challenges . They require supplementation with special ingredients that have particular functions as cell nutrients . In addressing those issues, cell culture engineers have discovered a whole new use for the analytical methods that are becoming ever more important in bioprocess development: media and supplement characterization and optimization . In the 21st century, it seems as though the more you can define your process, the more you need to do so .

Production PAT: As part of the US FDA’s 21st-century risk-based approach to pharmaceutical quality, the process analytical technology (PAT) initiative arrived on the scene about the same time as BPI — with the “final report” and guidance document published in 2004 . At first, everyone was talking about PAT, but no

BPI ADV INSTRUMENTS 0911.indd 1 9/23/11 1:21:13 PM

one quite knew what to say about it . Some vendors saw opportunity and helped to make the case (6–8) . Visionary contract manufacturers saw a way to distinguish themselves (9, 10) . And large biopharmaceutical organizations could devote staff and resources to finding a path through the new landscape of quality by design (QbD) relating to production processes (11–13) .

Process Optimization: Cell line engineering is just the first step in bioproduction — and it’s only the first part of the animal cell culture success story . Under the influence of QbD, analytics have become more important to biopharmaceutical production process development than ever before . In the interest of establishing design space and controlling outcomes, companies are characterizing cell lines and culture media as well as delving into the details of scale-up and flow dynamics — especially for new processes using disposable bioreactors . Fed-batch production is still the most commonly used culture mode, but interest in perfusion is on the rise as process and hardware improvements are improving its suitability for large-scale animal cell culture (14–17) .

refereNCeS1 Coco-Martin JM, Harmsen MM. A Review of Therapeutic

Expression By Mammalian Cells. BioProcess Int. 6(6) 2008: S28–S33.2 Nechaeva E, et al. New Technology for Producing Live Influenza

Vaccine. BioProcess Int. 2(3) 2004: 52–55.3 Ludwig DL. Mammalian Expression Cassette Engineering for

High-Level Protein Production. BioProcess Int. 4(5) 2006: S14–S23.4 Johnson T. Promises and Pitfalls of Cell Line Adaptation.

BioProcess Int. 4(5) 2006: S52–S56.

5 Broedel SE Jr., Papciak SM. The Case for Serum-Free Media. BioProcess Int. 1(2) 2003: 56–58.

6 Carvell JP. Monitoring “Live” Cell Concentrations in Real Time. BioProcess Int. 1(1) 2003: 70–76.

7 Logan D, Carvell J. A Biomass Monitor for Disposable Bioreactors. BioProcess Int. 9(1) 2011: 48–54.

8 Kaiser C, Carvell J, Luttmann R. A Sensitive, Compact, In Situ Biomass Measurement System. BioProcess Int. 5(1) 2007: 52–55.

9 Tholudur A, et al. Comparing Automated and Manual Cell Counts for Cell Culture Applications. BioProcess Int. 4(9) 2006: 28–34.

10 Abts H, Arain S. Process Monitoring in Suspension–Adapted CHO Cell Cultures. BioProcess Int. 6(1) 2008: 64–66.

11 Venable D, et al. High-Throughput and Quantitative Detection of Residual NS0 and CHO Host Cell Genomic DNA. BioProcess Int. 5(6) 2007: 56–61.

12 Schmidt J, et al. Monitoring ATP Status in the Metabolism of Production Cell Lines. BioProcess Int. 6(11) 2008: 46–54.

13 Tsai WL, et al. Noninvasive Optical Sensor Technology in Shake Flasks. BioProcess Int. 10(1) 2012: 50–56.

14 Li L, et al. A Single-Use, Scalable Perfusion Bioreactor System. BioProcess Int. 7(6) 2009: 46–54.

15 Whitford WG. Interest in Hollow-Fiber Perfusion Bioreactors Is Growing. BioProcess Int. 7(9) 2009: 54–64.

16 Bonham-Carter J, Shevitz J. A Brief History of Perfusion Biomanufacturing. BioProcess Int. 9(9) 2011: 24–31.

17 Langer ES. Trends in Perfusion Bioreactors. BioProcess Int. 9(10) 2011: 18–22.

Cheryl Scott is cofounder and has been senior technical editor of BioProcess International since the first issue; 1-646-957-8879; cscott@bioprocessintl.com.

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Stedim North America), and Richard Pearce (EMD Millipore’s director of strategy and business development) for their willingness to share their knowledge of the industry with us .

Wednesday’s roundtable (21 June 2012) began where BPI’s March cell-therapy supplement had left off to address “Cell Therapies: Building the Pillars to Success .” Under the expert guidance of chair Jon Rowley (innovation director of cell processing technologies at Lonza), the group talked about ways in which cell therapies can be brought to full commercial realization . Panelists Chris Mason (University College London professor), Robert Speziale (Invetech’s vice president of business development), and Barry Rosenblatt (president of SME Biotech Consulting) kept the discussion lively and topical . And one final roundtable on Thursday morning (22 June 2012) was chaired by John Helfrich of Accelrys, who presented insights on “CGMP Operational Excellence and Infrastructure: Harmonization from Lab to Plant .”

Tuesday morning’s upstream talks looked at optimizing strain design and development, technologies for closing single-use upstream processes, and the economic impact of single-use bioreactors . The afternoon’s downstream presentations addressed using disposable resins in harvest operations, next-generation PEGylation technologies, high-concentration buffer reformulations, single-use depth filtration, new methods of screening for microbial contamination, and technologies for driving down purification costs .

Wednesday’s presentations continued the cell-therapy theme from that morning’s panel . Speakers addressed cell expansion and scale-up strategies, controlling and optimizing cellular raw materials, and in general, further steps and technologies needed for commercial manufacturing .

Check them out: You can listen to the BPI Theater podcasts online at www .bpidm .com .

With BIO scheduled much earlier next year (22–25 April 2013, in Chicago), we are already signing up speakers and researching themes for our next BioProcess Theater . On behalf of BioProcess International, I wholeheartedly thank everyone who helped this year’s audiences enjoy such state-of-the-art presentations . And I invite you to contact us (by emailing Brian Caine, bcaine@bioprocessintl .com) if you have a topic to suggest for 2013 .

S . Anne Montgomery editor in chief

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The Votes Are In!

BioProcess International Announces Finalists for the 2012 Program, A Decade of BioProcess

On 15 August 2012 BioProcess International announced the 36 finalists for the 2012 BioProcess International Awards — Honoring a Decade of BioProcess. Finalists were determined through an independent judging process, and the results were tabulated and certified by Deloitte & Touche, LLC.

To view the names of the finalists and descriptions of their industry contributions, please visit http://awards.bioprocessintl.com/finalists — or read the special 20-page award finalist insert in BioProcess International’s September supplement, The Official Pre-Event Planner of the BPI Conference & Exhibition (which you have received with this issue).

The 2012 BioProcess International Awards recognize the outstanding products, services, partnerships, and people that have had the greatest impact on upstream processing, downstream processing, and manufacturing.

Awards Dinner and Ceremony: On Tuesday, 9 October 2012, at the BioProcess International Conference & Exhibition, BPI will host a special, closed-door awards reception, dinner, and ceremony to honor all 36 finalists and announce the 12 winners for each of the four categories: Technology of the Decade, Technical Application of the Decade, Collaboration of the Decade, and Thought Leader of the Decade.

If you would like to purchase a seat ($125) for the 2012 BioProcess International Awards Dinner and Ceremony, please visit www.ibclifesciences.com/BPI/register.xml?step=start and enter priority code BPIEHO12BC. If you purchase a dinner ticket, you may also register for a complimentary exhibit hall and keynote pass or receive a special 20% discount to attend the conference.

The staff of BPI congratulates the finalists and looks forward to announcing the winners in October!

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