Implementation of the USP GMP Potency Bioassay Suite - Webinar By ComplianceOnline (Biotech Training)
Venue: Online Event
|Event Date/Time: Jan 26, 2012||End Date/Time: Jan 26, 2012|
Potency bioassays are a regulatory requirement for release and stability testing of all biopharmaceutical products. Guidelines have remained vague on bioassay expectations due to the large assortment of mechanisms, end points and targets required for these assays. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy, precision and parallelism expectations. The draft USP Bioassay suite consists of the following new chapters: USP 1032, 1033 and 1034). These chapters will be finalized soon and are already being accepted as a coherent data-driven approach to develop, analyze and validate potency assays.