Life Cycle Validation of GMP Potency Bioassays

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 development phase to maintain scientific rigor and meet regulatory expectations.

This webinar provides a logical plan to progress the potency bioassay from a tool to assist in pre-clinical process evaluation throughout final commercial implementation. The presentation provides strategies to comply with current regulatory guidance like the new USP chapters for bioassay potency (USP 1032, USP 1033 and USP 1034) and discusses options to determine acceptance parameters not only for the precision, parallelism and accuracy of the method but also for the potency of each sample. The participants in this webinar will learn a common sense chronological pathway that can easily be adapted to the successful fit-for-purpose validation of any biopharmaceutical method.

Areas Covered in the Seminar:

• Rational approaches to bioassay selection and optimization.
• Effective transition of bioassays from early to late stage product development.
• Strategies to increase accuracy and repeatability.
• Techniques to avoid common technical problems.
• Guidelines for bioassay validation and regulatory documentation.
• Steps for preparing a method for technology transfer and commercial validation.
• Implementation of USP 1032, 1033 and 1034.

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

Instructor Profile:

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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