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

March 4th, 2019 by Aryo A. Nikopour

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

Life science - cells in petri dishes

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.

Posted in: BioProcess Online

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