Evolution of an Early-phase Cell Potency Assay
Thursday, May 23, 2019
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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.
Potency Assay Team Leader, Biologics Characterization
Intertek Pharmaceutical Services