Phase Specific Validation of Potency Bioassays

Instructor: Ana Menendez
Product ID: 701530
  • Duration: 60 Min
Learn the current regulatory guidances in USP1034 chapter of analyzing bioassays, and USP1033 chapter of bioassay validation and know how to take the potency bioassay from pre-clinical development throughout final commercial implementation.

recorded version

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Last Recorded Date: Jan-2010

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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.

Who Will Benefit:
  • Bioassay and analytical scientists
  • Validation specialists
  • Project Management
  • Regulatory staff
  • QA/QC
  • Outsourcing Professionals
  • Consultants

Instructor Profile:
Ana T. Menendez, Ph.D. is Senior Director of Biotechnology at Catalent, a full-service solution provider to the biopharmaceutical industry. Dr. Menendez implemented biotesting at Catalent with the following services: Potency bioassays, PK/PD, immunogenicity and viral clearance. 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. 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 from NY Medical College. She is an international speaker and course instructor on Immunogenicity and Bioassay Method Development and Validation..

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