White Paper

Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance

By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). Cell culture-based potency assays are often the preferred format for determining biological activity since they measure the physiological response elicited by the product and can generate results within a relatively short period of time unlike typical animal-based assays. Cell-based potency assays are also often the only functional assays used for product release and stability programs. Other uses of cell-based assays include qualification of internal reference standards; characterization of process intermediates, formulations and degradation products; and support of changes in the product production process.