Implementation of the USP GMP Potency Bioassay Suite

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

Why Should You Attend:

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.

This presentation provides logical advice on how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products. We will also review critical validation parameters and use case studies to highlight the benefits of using the new chapters.

Areas Covered in the seminar:

• Step by step guide to interpreting new USP Bioassay suite.
• Review current expectations for parallelism.
• Decrease failure rate for precision and accuracy.
• Set specifications for the validation protocol and sample analysis.
• Recognize differences between Phase I/II and Phase III Validations.
• Case Studies.

Who Will Benefit:

The following personnel from biotech and pharmaceutical companies and laboratories will benefit:

• Bioassay and Analytical Scientists
• Validation specialists
• Project Management
• Regulatory staff
• QA/QC
• Outsourcing Professionals
• Consultants