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Symposium #1: Prevention of Microbial and Viral Contamination of Mammalian Cell Culture Processes Lessons Learned and Case Studies (Room 554) 1:00 Chairperson’s Remarks Robert D. Kiss, Ph.D., P.E., Director, Late Stage Cell Culture - Pharma Technical Development, Genentech, Inc. 1:15 How to Prevent Microbial Contaminations of Bioreactors, and Successful Strategies for Addressing Them if/when They Occur Andrew Brewer, Senior Engineer, Biologics Manufacturing Science and Technology, Genentech, Inc. 1:45 CSI GMP Production; Lessons from the Contamination Scene Katie Stewart, M.S., Technical Training Supervisor, Technical Training, Human Genome <strong>Sciences</strong> Inc. 2:15 CASE STUDY Microbial Contamination in a CHO Based Production Culture – A Case Study Jim McColgan, Associate Director, Pilot Lab and Production Operations, Pfizer Global Manufacturing 2:45 Networking Refreshment Break 3:15 Successful Elimination of Parvovirus (MVM) Infections of Industrial Scale Cell Cultures – Two Case Studies Tim Hughes, Director, Processes & GMP Facilities, CSL Ltd., Australia 3:45 Inactivation of Viruses and Mycoplasma by Several Barrier Methods Houman Dehghani, Ph.D. Principal Scientist, Biosafety Development Group, Amgen Inc. 4:15 Audience Interactive Panel Discussion 5:00 Close of Symposium Monday, September 20, 2010 • Pre-Conference Symposia 12:00 Registration (Exhibit Hall Foyer) Symposium #2: How Much Data is Enough The Statistical Approach to Process Validation (Ballroom C) 1:00 Chairpersons’ Remarks Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; Former Senior Staff Fellow, OPS, CDER, US FDA 1:05 Statistical Assurance of Process Knowledge and Control: The Means to a Validated Process Ali M. Afnan, Ph.D., Principal, Step Change Pharma, Inc.; Former Senior Staff Fellow, OPS, CDER, US FDA 1:50 Elements of a Quality by Design Approach for Biopharmaceutical Drug Substance Bioprocesses Nathan McKnight, Ph.D., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 2:35 Networking Refreshment Break 3:00 New, Unpublished Data CASE STUDY Process Understanding: How do We Demonstrate that We Know What We Know Carl A. Anderson, Ph.D., Associate Professor of Pharmaceutical <strong>Sciences</strong>, Duquesne University 3:45 Strategies for Multi-Variate Studies of Critical Process Parameters Ronald D. Snee, Ph.D., Founder and President, Snee Associates 4:30 Audience Interactive Panel Discussion 5:00 Close of Symposium Symposium #3: Technology Transfer for Biopharmaceuticals (Ballroom E) 1:00 Chairperson’s Remarks Jean Bender, Ph.D., Principal Engineer, Genentech, Inc. 1:15 Technology Transfer from Development to Manufacturing John Knighton, MBA, Director, Pharmaceutical Development & Manufacturing <strong>Sciences</strong>, Johnson & Johnson Pharmaceutical Research & Development 1:45 Technology Transfer and Scale-up of an Antibody Process Magnus Glad, Ph.D., Senior Project Manager, Biopharmacy & Protein Technology, BioInvent International, Sweden 2:15 Technology Transfers: Internal versus External, Domestic versus International Younok Dumortier Shin, Ph.D., Technical Lead, Manufacturing Technology, Bristol-Myers Squibb 2:45 Networking Refreshment Break 3:15 Applying Principles of Operational Excellence in Managing Technology Transfer Projects Greg Zarick, M.S., PMP, Associate Director of Project Management, Lonza Biologics, Inc. Michael J. Gorman, M.S., Certified Lean Six Sigma Black Belt and Project Manager, Operational Excellence, Lonza Biologics, Inc. 3:45 Integration of Quality Risk Management into Technology Transfer Lori Richter, Quality Risk Management Associate, Global Quality Risk Management, Genentech, Inc. 4:15 Audience Interactive Panel Discussion 5:00 Close of Symposium Two Day Training Courses • Tuesday, September 21, 2010 - Wednesday, September 22, 2010 Introduction to Biopharmaceutical Manufacturing (Room 554A) Scott M. Wheelwright, Ph.D., President and CEO, Strategic Manufacturing Worldwide, Inc. Bioprocess Training Academy Protein Characterization for Biotechnology Product Development (Room 558A) Christine P. Chan, Ph.D., Senior Manager, Technology Development, Genzyme Corporation Cell Culture and Fermentation Bioprocessing (Room 554B) Regulatory Compliance in CMC Development (Room 558B) Antonio R. Moreira, Ph.D., Professor, Chemical and Biochemical Engineering, Vice Provost, University of Maryland, Baltimore County Bruce K. Burnett, Ph.D., RAC (US, EU), Director, Regulatory Affairs, Duke University Sneak Preview: Be the first to visit the newest Xcellerex FlexFactory Tuesday, September 21st at 12noon Please join Xcellerex and <strong>IBC</strong> for a tour of our newly completed FlexFactory® facility in Marlborough, Massachusetts. This biomanufacturing facility will open for GMP production in October, less than 6 months from completion of final design. The facility, which encompasses upstream and downstream operations, demonstrates the unprecedented speed at which new capacity can be achieved with FlexFactory technology. Coach transportation will be provided, at 12:00 noon on Tuesday, September 21. Please register for the Site Tour at the BPI Registration Area. BioProcess International Conference & Exhibition 7
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