This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.
Potency bioassays are a regulatory requirement for all biopharmaceutical products yet validation guidelines are vague due to the large assortment of end points and targets. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy and precision. The seminar also reviews critical validation parameters and uses case studies to highlight common pitfalls and their solutions.
What will Attendees Learn?
- Selecting the appropriate bioassay for your product
- Preparation of GMP cell banks
- Maximizing precision and accuracy
- Setting specifications for the validation protocol
- Recognizing differences between Phase I/II and Phase III Validations
- Common pitfalls and solutions
- Case Studies
Who Will
Benefit
- Bioassay and analytical scientists
- Validation specialists
- Project Management
- Regulatory staff
- QA/QC
- Outsourcing Professionals
- Consultants
Instructor Profile:
Ana T. Menendez ,is Senior Director of Biotechnology at Catalent, a full-service solution provider to the pharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Cellular Technologies, Molecular Technologies and Virology. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers.
Dr. Menendez joined Catalent from Bristol-Myers Squibb (BMS) where she held a number of positions of increasing responsibility from 1995 to 2001. As the head of the Cancer Cell Biology department Dr. Menendez identified and/or optimized several compounds currently in clinical trials, including second-generation taxanes and inhibitors of the ras and src oncogenes. Her seminal apoptosis research (programmed cell death) was critical to the incorporation of a drug’s pro-apoptotic potential into the BMS decision pathway for oncology drug generation. While Associate Director of Regulatory Sciences she assisted the transition of Oncology and Infectious Diseases leads from the lab bench to the clinic. From 1982 to 1995, Dr. Menendez pioneered monoclonal antibody technology at American Cyanamid/Wyeth and was responsible for all the immunoassays and in vitro bioassays for Mylotarg, an anticancer monoclonal antibody – toxin conjugate that was approved in 2000.
Dr. Menendez obtained her Ph.D. in Microbiology/Immunology in 1995 from NY Medical College while simultaneously fulfilling her supervisory functions at Wyeth. She teaches courses and leads workshops on Bioassay Method Development and Validation and is a frequent speaker at biopharmaceutical conferences.
