Agenda
Topic Overview
The contamination of large-scale cell culture manufacturing processes has occurred at a number of biopharmaceutical companies. These have resulted in significant negative impacts to companies, including unanticipated costs, delays in product development, and stock-out of commercial product. The impact of new broad-spectrum virus detection methods, contamination preparedness, and strategies to reduce the risk of contamination will be presented and discussed.
Presenter Biography
Michael E. Wiebe, Ph.D., President, Quantum Consulting, LLC
Dr. Wiebe is Founder and President of Quantum Consulting based in Redwood City, California. His consulting practice is focused on biotechnology development, biosafety, manufacturing, quality assurance and GMP compliance. He has 24 years of experience in the CMC aspects of biotechnology and has participated as a member of numerous product development teams that were successful in bringing new biotech products through the development pipeline and into commercial life. He has held positions at the following companies: Genentech, 1984-1998 (Senior Scientist, Cell Culture Development; Sr. Director, Quality Control); BioReliance, 1998-2001 (Chief Scientific Officer and Vice President of Quality & Regulatory Affairs); IDEC Pharmaceuticals, 2001-2003 (Vice President of Quality); Biogen Idec, 2003-2005 (Vice President of Corporate Quality & Drug Compliance); Novartis (formerly Chiron), 2005-2007 (Vice President of Quality Assurance for U.S. Biopharmaceutical Operations). Earlier in his career Dr. Wiebe held positions at Duke University Medical School (Research Fellow), Cornell University Medical College (Assistant & Associate Professor), and the New York Blood Center (Associate Investigator). He received his Ph.D. in Microbiology from the University of Kansas and his B.S. in Natural Sciences from Sterling College (Kansas).
Registration
Submit registration requests via e-mail to rsvp@wccpda.org with "WCC PDA June Dinner RSVP" as the subject line. Indicate name and company affiliation for each registrant. Seating is limited to the first 100 registrants! It is strongly encouraged that you register in advance to ensure seating at this event, and to allow us to provide an accurate head count for meals.
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Venue:
WCC PDA is hosting the 2010 Dinner Meeting Series at Dominic's Banquet Hall, located adjacent to the Inn at Oyster Point, 360 Oyster Point Blvd., South San Francisco, CA, 94080, (650) 589-1096. This venue overlooks the Oyster Point Marina and the Bay. To get there, take Hwy 101 to South San Francisco, exit at Oyster Point Boulevard. Head East on Oyster Point Boulevard and proceed approximately 1 mile to turn right on Marina Boulevard just past Gull Avenue stoplight. Turn immediately left into the first parking lot and proceed left to the Banquet Hall building that is separate from the Inn.
"Virus Contamination of Cell Culture Manufacturing Operations A Question of When, Not If"
Presented by Michael E. Wiebe, PhD, President, Quantum Consulting, LLC
June 17, 2010 | 6:00-9:30 PM | Dominic's at Oyster Point SSF, CA