Evolution of an Early-phase Cell Potency Assay

Thursday, May 23, 2019
11:00AM Eastern

Join us May 20-23, 2019 BioProcess International Digital Week, a global 4-day series of live educational webcasts and downloadable resources providing the latest insights for ground breaking bioprocessing, manufacturing, and supply chain strategies. To sponsor future digital events, contact partners@knect365lifesciences.com or request details.

Cell potency assays for determining biological activity are an important part of establishing safety and efficacy profiles of biologic drug products (ICH Q6B Guidance). These cell-based potency assays are key to characterisation programs, support of changes in production processes, product release and stability programs. Developing and maintaining a cell potency assay across its lifecycle can be challenging and this webcast covers the critical points in the evolution of an assay from the first steps in method development, method transfer through to longer-term assay maintenance where careful consideration of the regulatory issues and implementation of scientifically robust approaches are key to a well-performing assay.


Tom Miles
Potency Assay Team Leader, Biologics Characterization
Intertek Pharmaceutical Services