Potency Assays 101: How to Develop a CMC Relative Potency Assay

The potency assay for a typical biologic is usually the most complex assay in the release and stability specification. Potency methods should be designed to be as simple as possible to still reflect the mechanism of action (MOA) as is required in the regulations. The more steps, the more opportunities for variation and the worse the ultimate results will be. In some cases, multiple potency assays may be required if there are multiple MOAs of a molecule or to fully reproduce the MOA in vitro. In this eBook, we break the development of a potency assay down into its constituent steps to provide an understanding of the process.

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Manufacturing Support (CMC)