Biopharmaceutical Production Conference - July 20 - July 22 2005 - San Francisco, CA

Dear Colleague,
The mission of the Biopharmaceutical Production event is to assist biopharmaceutical process scientists in optimizing scalable and transferable cell culture, purification, comparability and in-process analytical testing processes. This conference is designed to help you maximize your limited resources to identify and streamline the critical steps and reduce development time and cost of biopharmaceutical production. The conference is organized over three days.
Full Day Workshop
8:00 Registration and Morning Coffee
8:30 Chairperson?s Welcome and Opening Remarks
Feroz Jameel, PhD, Principal Scientist Drug Product and Process Development,
AMGEN
8:45 Freezing and Thawing - Lab Scale vs Bulk Scale
Effect of controlled vs uncontrolled freezing and thawing-Cryoconcentration
Effect of rates, Degree of supercooling ? Does ice crystal size matters? How do you control it? PAT?
Does the lab-scale developed freeze/thaw process work for production scale? If not, what are the additional challenges?
Physical techniques to characterize the stability/integrity of drug active in frozen state
Storage temperature? Should be above Tg? or below Tg?
Techniques available
Vial breakage- Causes for vial breakages and solutions to eliminate