Developing Robust Potency Assays for Validation

Dr. Peter Wunderli

In this episode, Dr. Wunderli discusses PPD's recent laboratory facility expansion, outlines challenges and critical factors in cell-based bio bioassay product development, talks about disease states suitable for this type of technology, and finally, takes a look into the future of cell-based assays.

Thought Leader:
Peter Wunderli, Ph.D., Associate Director, Biopharmaceutical Services at PPD

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Development and Qualification of Potency Assay Methods to Support Early Phase Release and Stability Testing of a Biotherapeutic Formulated with a Bioresorbable Carrier

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PPD's Cell Based Assay Laboratory was contracted by a client to improve the performance of a potency assay that had been developed for their biological product. The assay met pre-established qualification specifications for linearity, precision, and specificity and has been successfully implemented in testing the release and stability of multiple product lots, across an 18 month testing period.

Provided by: PPD