Why Should You Attend:
Potency bioassays are an integral part of release testing and stability studies for biotechnological products. There is a lack of clarity of how much work is required at each clinical phase to maintain scientific rigor and meet regulatory expectations.
This presentation provides a logical plan to take the potency bioassay from pre-clinical development throughout final commercial implementation. The main body of the talk describes current regulatory guidances and discusses options to determine acceptance parameters not only for the method but also for each sample. Participants in this seminar will learn a common sense chronological pathway that can easily be adapted for any biopharmaceutical assay.
Areas Covered in the seminar:
* Differences between qualification and validation.
* Situations when can a binding method be used.
* Timeline and expectations for Master and Working Cell Banks.
* Overview of USP1034 chapter of analyzing bioassays.
* Overview of USP1033 chapter of bioassay validation.
* Phase appropriate specifications for system suitability.
* Implementation and interpretation of process charts.
lease contact CustomerCare to avail 15% Christmas Offer on Regular Pricing (650-620-3937)
Send to friendSign In to get started!
