Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies

By Ming Li, Ph.D., Principle Scientist & Team Lead, Biopharmaceutical Developmental and Aryo A. Nikopour, SVP of Scientific & Technical Services

Dr. Ming Li, Principle Scientist and Team Lead in the Biopharmaceutical Developmental department at Nitto Avecia Pharma Services, discusses some basics of cell-based assay and why it's the preferred method to support potency analysis for bio therapeutic drugs. Understand developing and optimizing cell-based potency assay as well as phase appropriate method validation. The webinar concludes by covering a typical workflow to transfer cell-based potency assay into a GMP environment, and best practices to maintain the long term performance of the assay. Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services at Nitto Avecia Pharma Services joins the Q&A session at the end of the webinar.

This presentation demonstrates that in vitro, cell-based assays is an indispensable tool to quantify the biological activities, and to support the potency tests, for bio therapeutics. Development of cell-based potency assay should be based on mechanism of action, systematic approach to identify and control variability, and to reduce bias, will help to build a more robust method. Also, applying a proper curve fitting and parallelism assessment, as well as setting proper assay acceptance criteria, will insure the consider assay performance over time. Key parameter trending, critical reagent management, as well as rigorous analyst training, will all contribute to a long term successful sample testing program in the GMP environment.

Speakers

Ming Li, Ph,.D
Principle Scientist and Team Lead in the Biopharmaceutical Developmental
Nitto Avecia Pharma Services

Aryo A. Nikopour,
Senior Vice President of Scientific and Technical Services

Nitto Avecia Pharma Services

Nitto Avecia Pharma Services is your single solution for premier contract development and manufacturing services. Nitto Avecia Pharma Services supports the pharmaceutical, bio pharmaceutical, and medical device industries with a complete package of cGMP services, small to large molecules including, formulation and processing development, parental manufacturing, analytical development, analytical chemistry, stability, structural chemistry, microbiology, and drug delivery device testing.