Why Cell-based Assay Is The Preferred Method To Support Potency Analysis For Biologics

By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services and Ming Li, Ph.D., Principle Scientist and Team Lead in Biopharmaceutical Development, Nitto Avecia Pharma Services

Unlike small molecule therapeutics, which are chemically synthesized, stable, and easily characterized, the biotherapeutics must be produced in in a living cell and present a number of challenges. Biotherapeutics are high molecular weight products with complex secondary and tertiary structure and post-translational modifications. All of which are critical to the molecule’s function and desired therapeutic effect.

Following the ICH Q6B guideline, when extensive physico-chemical information is insufficient to confirm the higher order structure for these complex molecules, the biological activity needs to be determined. Biological activity is measured by potency assays.