Tag: <span>certificate of authenticity</span>

Among the battery of assays needed to release viral-based gene therapy biologics products, the potency assay is typically the most customized and unique of all the tests found on a Certificate of Analysis (COA). Where many safety, purity, and to some extent, identity assays can be applied with little to no custom modifications, the potency assay should be directly related to the biological activity of the construct. This aspect of the potency assay requires that development, characterization, and validation efforts be started early in the lifecycle of the product, and adequate resources should be allocated to this end. This article will cover a brief overview of available regulatory guidances, discuss hallmarks of a good cell-based potency assay, and provide a case study of an assay that was developed for a Phase 3 gene therapy product…