Bioreactor Systems: Development, Design and Operation

Gain understanding for the development, selection, design, validation, operation and regulatory compliance of large scale bioreactor systems used for production of therapeutic proteins and related products. Workshops on the interaction of product characteristics, host cell selection, and bioreactor development, and on the troubleshooting of manufacturing bioreactors will involve all participants working in teams. Two special lectures will highlight fundamental and practical aspects of bioprocesses for cell therapy products.

Course Directors

Donald Kirwan, Professor of Chemical Engineering at the University of Virginia, Director of the Center of Bioprocess Development, fellow of the AIChE and AIMBE, founding director of SBP.

• BSChE, Illinois Institute of Technology
• MSChE and Ph.D.ChE, University of Delaware
• Conducted research in protein purification and recovery at Monsanto. Academic research program has included fermentation and cell culture; biocatalysis, the recovery of pharmaceuticals and proteins by precipitation and crystallization.

Dan Stark, Director of Manufacturing Sciences and Technical Services, Genentech, Inc., Vacaville, CA

• Ph. D. ChE, University of Virginia
• Worked for Zymogenetics, Bristol-Myers Squibb, Eli Lilly and Company and Exxon in various engineering and process development positions. Experience includes cell culture, bacterial and yeast process development, facility design and therapeutic protein manufacturing.

Bioprocessing Overview Icon
A (B) next to a course description indicates that it is part of the “Bioprocessing Overview.”

Monday, May 21

08.30 - 10.00
Protein Properties (B)
Warren MacKellar, Senior Research Advisor, Biosynthetic Technical Services, Eli Lilly and Co.

10.30 - 12.00
Mammalian Cell Characteristics (B)
William M. Miller, Professor of Chemical and Biological Engineering, Northwestern University

13.00 -14.30
Quantitative Analysis of Cell Cultures (B)
Donald J. Kirwan, Professor of Chemical
Engineering, University of Virginia

15.00 - 16.30
Host Cell Systems for Protein Production (B)
Gary Wilson, President, Wilson Bioscience
Consulting

Tuesday, May 22

08.30 - 12.00
Development of Cell Culture Reactors and Processes: I and II (B)
Chris Hwang, Senior Director, Technology
Development, Genzyme Corp.

13.00 - 16.30
Workshop I: Bioreactor Development
Gary Wilson, President, Wilson Bioscience
Consulting Shawn Lawrence, Staff Engineer, Regeneron Pharmaceuticals

Wednesday, May 23

08.30 - 10.00
Introduction to Cell Therapies (B)
William M. Miller, Professor of Chemical and Biological Engineering, Northwestern University

10.30 - 12.00
Cell Therapy Case Study: GVAX, GM -CSF Cellular Immunotherapy for Cancer (B)
Andy A. Lin, Vice President, Process Sciences, Cell Genesys, Inc.

13.00 - 14.30
Impact of Regulatory Requirements on Bioreactor Design and Operation (B)
Gretchen Bowker, Consultant,
Safis-Solutions, LLC.

15.00 - 16.30
Cell Culture Bioreactor Process Characterization and Validation (B)
Michael Glacken, Head, Biologics Process
Development, Millenium Pharmaceuticals, Inc.

Thursday, May 24

08.30 - 10.00
Manufacturing Scale Bioreactors: Design and Implementation (B)
Dan Stark, Assoc. Director Manufacturing
Sciences, Genentech, Inc.

10.30 - 12.00
Large Scale Bioreactors That Work! (B)
Tim Hughes, Senior Director, Class A Initiatives, Genentech, Inc.

13.00 - 16.30
Workshop II: Bioreactor Trouble Shooting
Tim Hughes, Senior Director, Class Initiatives, Genentech, Inc.
Dan Stark, Assoc. Director Manufacturing
Sciences, Genentech, Inc.