Building a Robust Biological Assay for Potency Measurement

摘要

Potency is a critical quality attribute of a biological product and is often determined by a biological assay (also called bioassay or biopotency assay). Specifically, potency is the biological activity or capacity of a product directly linked to itsclinical efficacy. Potency tests are performed as part of product release, comparability studies, and stability testing. Nonbiological methods — which measure a product's molecular or biochemical characteristics (e.g., ligand-binding assay) — have gained interest as replacements for often troublesome bioassays. Even with recent advancements in alternative methods, regulatory agencies expect manufacturers to make considerable efforts to first develop a bioassay, largely because of the method's abilityto direcdy assess a product's biological function. The results of a bioassay can be used to gauge manufacturing consistency and product shelf life.