Outcomes from a cell viability workshop: fit-for-purpose considerations for cell viability measurements for cellular therapeutic products

Published: 14 May 2021
Commentary
Laura Pierce,
Laura Pierce
Author for correspondence: Biosystems and Biomaterials Division, Materials Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, USA laura.pierce@nist.gov
Sumona Sarkar,
Sumona Sarkar
Biosystems and Biomaterials Division, Materials Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, MD, USA
Leo Li-Ying Chan,
Leo Li-Ying Chan
Department of Advanced Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA, USA
Bo Lin,
Bo Lin
Department of Advanced Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA, USA
Jean Qiu
Jean Qiu
Department of Advanced Technology R&D, Nexcelom Bioscience LLC, Lawrence, MA, USA

Fit-for-purpose cell viability measurement methods are urgently needed for the characterization and testing of cellular therapeutic products (CTPs) and their manufacturing processes. A cell viability workshop held at the virtual Cell Therapy Analytical Development Summit in December 2020 brought together stakeholders from academia, federal government institutes, instrument manufacturers, and cellular therapeutic product manufacturers to explore common challenges in viability measurements, as well as to address control measures and considerations for the selection of viability assays that are targeted toward the intended use of the biological sample. This report summarizes the key findings of the workshop and identifies needs and gaps for cell viability assay standards development.

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