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PharmaVOICE Editors' Blog

Showing posts with label biotherapeutic. Show all posts
Showing posts with label biotherapeutic. Show all posts

Wednesday, May 1, 2013

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

Potency Assay Methods