'Hard Cell'': Potency Testing for Cellular Therapy Products

摘要

Potency testing is defined in 21 CFR Part 600.3(s) as "the specific ability or capacity of the product, as indicated by appropriate laboratory tests or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to effect a given result" (l). Potency measurement is especially important for complex products such as cellular therapies (CTs). It is considered an essential aspect of the quality-control system for a CT drug substance and drug product.It is performed to assure identity, purity, potency (also called strength in FDA documents), and stability of products used during all phases of clinical study as well as for licensed products (2, 3).