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Outcomes from a Cell Viability Pre-Conference Workshop: Fit-For-Purpose Considerations for Cell Viability Measurements in Cell and Gene Therapy

Published

Author(s)

Laura Pierce, Sumona Sarkar, Leo Chan, Bo Lin, Jean Qiu

Abstract

Fit-for-purpose cell viability measurement methods are urgently needed for the characterization and testing of cell and gene therapy products and their manufacturing processes. A recent Cell Viability Workshop held at the virtual Cell Therapy Analytical Development Summit brought together stakeholders from academia, federal government institutes, instrument manufacturers, and cellular therapy 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.
Citation
Cell and Gene Therapy Insights

Keywords

cell therapy, manufacturing, regenerative medicine, cell viability, standards development, measurement uncertainty

Citation

Pierce, L. , Sarkar, S. , Chan, L. , Lin, B. and Qiu, J. (2021), Outcomes from a Cell Viability Pre-Conference Workshop: Fit-For-Purpose Considerations for Cell Viability Measurements in Cell and Gene Therapy, Cell and Gene Therapy Insights, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=932193 (Accessed February 23, 2024)
Created May 14, 2021, Updated January 6, 2023