The economic challenges faced by today’s biopharmaceutical industry are well documented. Revenues are contracting due to patent expiries, generics competition and pricing pressure from payers that are demanding clearer demonstration of product value. By 2016, patent expiries in developed markets will save payers $127 billion, primarily in the US.1 Innovative new products are scarce as R&D budgets chase increasingly difficult scientific problems. For those products that successfully make it through development, the regulatory approval bar is higher than ever.

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Introduction
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.