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Innovations in Cell Culture | Bioprocess Vol. 12, Supplement 5 A SPECIAL SUPPLEMENT TO BIOPROCESS INTERNATIONAL Innovations in Cell Culture IN ASSOCIATION WITH New Flexsafe Bag Family. New PE Film. New Benchmark. Our new Flexsafe bags ensure an excellent and reproducible growth behavior ONE FILM FOR ALL with the most sensitive production cell lines. The optimization of the resin formulation, the complete control of our raw materials, the extrusion process and the bag assembly guarantee a consistent lot-to-lot cell growth performance. www.sartorius-stedim.com/flexsafe USP – DSP – F+F VOLUME 12 SUPPLEMENT 5 SEPTEMBER 2014 From the Editor ................................... 2 Robust and Convenient Single-Use Processing: The Superior Strength and Flexibility of Flexsafe Bags......................38 SECTION 1: UPSTREAM TECHNOLOGIES Elisabeth Vachette, Christel Fenge, Jean-Marc Cappia, Automated Miniature Bioreactor Technology: Optimizing Early Lucie Delaunay, Gerhard Greller, and Magali Barbaroux Process Development in Fermentation and Bioprocessing . 3 Enhanced Assurance of Supply for Single-Use Bags: Mwai Ngibuini Based on Material Science, Quality By Design, Single-Use, Stirred-Tank Bioreactors: Efficient Tools for Process and Partnership with Suppliers ..............................43 Development and Characterization ...........................7 Jean-Marc Cappia, Elisabeth Vachette, Carole Langlois, Andre Grebe, Christel Fenge, and Jean-François Chaubard Magali Barbaroux, and Heiko Hackel Design of Experiments with Small-Scale Bioreactor Systems for Development and Qualification of a Scalable, Disposable Efficient Bioprocess Development and Optimization..........10 Bioreactor for GMP-Compliant Cell Culture ...................47 Andree Ellert and Conny Vikström Anne Weber, Davy De Wilde, Sébastien Chaussin, Thorsten Adams, Susanne Gerighausen, Gerhard Greller, and Christel Superior Scalability of Single-Use Bioreactors ................14 Fenge Davy De Wilde, Thomas Dreher, Christian Zahnow, Ute Husemann, Gerhard Greller, Thorsten Adams, and Christel Fenge Verification of New Flexsafe STR Single-Use Bioreactor Bags: Using a CHO Fed-Batch Monoclonal Antibody Production Process Integrated Optical Single-Use Sensors: Moving Toward a True at 1,000-L Scale..............................................53 Single-Use Factory for Biologics and Vaccine Production......20 Regina Reglin, Sebastian Ruhl, Jörg Weyand, Davy De Wilde, Henry Weichert, Julia Lueders, Joerg Weyand, Ute Husemann, Gergard Greller, and Christel Fenge Thorsten Adams, and Mario Becker Pressure Decay Method for Post-Installation Single-Use Diatomaceous Earth Filtration: Innovative Single-Use Concepts Bioreactor Bag Testing .......................................58 for Clarification of High-Density Mammalian Cell Cultures ....25 Magnus Stering, Martin Dahlberg, Thorsten Adams, Tjebbe van der Meer, Benjamin Minow, Bertille Lagrange, Davy De Wilde, Christel Fenge Franziska Krumbein, and François Rolin Total Solutions Support the Growth of a Dynamic Industry: An Designing Full Solutions for the Future: Interview with Reinhard Vogt and Stefan Schlack.............62 An Interview with Christel Fenge.............................29 Brian Caine and S. Anne Montgomery Brian Caine and S. Anne Montgomery LAST WORD SECTION 2: DEVELOPMENT OF Disposables for Biomanufacturing: A User’s Perspective ......67 THE NEW FLEXSAFE BAG FAMILY Berthold Boedeker Consistently Superior Cell Growth Achieved with New Polyethylene Film Formulation...............................34 Christel Fenge, Elke Jurkiewicz, Ute Husemann, Thorsten Adams, Lucy Delaunay, Gerhard Greller, and Magali Barbaroux EDITORIAL OFFICES SALES AND ADMINISTRATIVE OFFICES PO Box 70, Dexter, OR 97431 One Research Drive, Suite 400A Production and Creative Manager Westborough, MA 01581 Genevieve McCarthy 1-212-520-2752 Editor in Chief (sales inquiries, media kits, advertising) [email protected] S. Anne Montgomery [email protected] Publisher Director of Audience (article and supplement queries, editorial policies) Brian Caine 1-508-614-1443 Development and Manufacturing [email protected] Nora Pastenkos 1-212-520-2733 Senior Technical Editor [email protected] Cheryl Scott Eastern Regional Sales Manager [email protected] Christopher Johnson 1-508-614-1273 Marketing and Digital Content Strategist (press releases, art submissions, design) [email protected] Leah Rosin 1-508-614-1167 [email protected] Managing Editor Western Regional Sales Manager Maribel Rios [email protected] Mike Kelly 1- 646-957-8974 List Rental Amy Miller (article queries, special projects) [email protected] 1-508-614-1251 [email protected] Reprints Rhonda Brown Editorial Assistant Alison Center European Sales Manager 1-866-879-9144 x194 [email protected] Joanna Taylor 44-(0)-20-7551-9392 [email protected] [email protected] Find BPI citations online in the Chemical Sales and Marketing Coordinator For subscription inquiries, call 1-847-763-4930, Abstracts Database (www.cas.org). Kim Rafferty 1-508-614-1226 toll free 1-877-232-2399, or email bioprocess@ [email protected] halldata.com. ©2014 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. SUPPLEMENT SEPTEMBER 2014 12(8)S BioProcess International 1 FROM THE EDITOR his special issue has come about through a long Among products highlighted in these articles and interviews collaborative process with our contacts at Sartorius is the company’s new bag tester. Proper handling of single-use T Stedim Biotech in Göttingen, Germany. It is the third such materials is another common theme these days. Users want to sponsored issue that BPI has published over the years with the prevent leaks and tears as well as ensure bag compatibility with company and the first one that we have produced in-house. We the products that come into contact with them. The bag tester is could not be happier with the results. yet another element of the company’s goal to provide total The aim here is to highlight technologies and responses to solutions to its customers. Along with a focus on training, key industry challenges rather than focus over much on offering clients such a tool should increase confidence in Sartorius itself. But the company’s long-standing culture of adoption of single-use systems overall. developing its own and integrating acquired technologies and The topic of scalability is often the proverbial elephant processes — toward its goal of providing total biomanufacturing lounging in the back of the room at single-use conferences. How solutions — is worth underscoring. In the two interviews in this large can single-use bags go? The consensus in this issue is that issue you will read about a company that has a long history of 2,000 L may be perfectly adequate, now that titers are higher investing in and positioning its technologies and related and processes can be scaled to run in parallel. This is not the last equipment for future needs, even when the current industry has word on the topic, of course, but a number of authors herein not been quite ready for them yet. In this risk-averse era, such discuss reasons for that conclusion. long-term thinking can require no small amount of corporate One of those reasons is that with Sartorius Stedim Biotech’s courage. Through its own R&D activities and combinations of recent acquisition TAP Biosystems and its scalable line of ambr licensing, partnering, and acquisitions the company has crafted bioreactors, the company just doesn’t see the need for larger its current identity and continues on a well-defined path. systems. Customers can use TAP systems to effectively optimize As part of this issue’s preparation, BPI publisher Brian Caine their processes and titers. Also, many larger companies still have and I traveled to the Sartorius Stedim Biotech facility in Göttingen, stainless steel equipment to which they transfer processes for Germany. There we interviewed Christel Fenge (vice president of large-scale manufacturing — so questions remain in the marketing for fermentation technologies), Reinhard Vogt industry about what biomanufacturing companies want and (executive vice president of marketing, sales, and services and a truly need at later processing stages. member of the administrative board), and Stefan Schlack (senior Thus, authors in this issue are primarily examining bioreactor vice president of marketing and product management). Brian and design innovations, qualification and GMP development, use of I were grateful for the time they devoted to speaking with us — those bioreactors with the company’s line of Flexsafe bags, all during a very busy few days. That week the company was also testing and qualification of the new film, and the status of conducting a two-day conference at its Sartorius College. sensor development. The latter will be an essential component Academic and industry speakers presented analyses
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