Implementation of the USP GMP Potency Bioassay Suite
Instructor:
Ana Menendez
Product ID: 701275
- Duration: 60 Min
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.
- 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
Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular molecular and immunological procedures. Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.
Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.
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