Article | January 22, 2019

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

Source: Nitto Avecia Pharma Services

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

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

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.