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

Cell & Gene Therapy Insights 2021; 7(4), 551–569

10.18609/cgti.2021.076

Published: 13 May 2021
Commentary
Laura Pierce, Sumona Sarkar, Leo Li-Ying Chan, Bo Lin, Jean Qiu

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.