How is a potency assay defined and developed throughout the course of a products life cycle?
Because potency is a product specific measurement, assays must be evaluated for each product individually. Because knowledge of the MoA generally increases through the product lifecycle, a potency assay used early in development may not be suitable at later stages. So it is unlikely that a single assay platform could be used between products or even between development phases for a single product. It is generally expected that during early clinical phases the critical biological activity of a product will be investigated and a related potency assay developed. As products or assays are better understood, assays may be added, removed, or refined to best demonstrate product quality, consistency, and potency. As product development proceeds, an improved or more relevant assay should be developed.
