How To Transfer Cell-based Potency Assays Into A GMP Environment And Maintain Performance

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

Like all living things, cells are sensitive to change. Cell-based assays, due to their high variability, are probably the hardest methods to transfer between labs.

Cell-based potency assays are especially challenging. They require significant experience and finesse to transfer from a non-GMP originating lab into a GMP environment.

Nitto Avecia Pharma Services provides cell-based assay expertise in a variety of relevant potency assays to support drug development, lot release, and stability programs through all phases of the product life cycle. To ensure a smooth and expedient transfer process, a typical workflow includes these initial steps.