Experimental and computational approach to establish fit-for-purpose cell viability assays

Author:

Pierce Laura1ORCID,Anderson Hidayah2,Sarkar Swarnavo1,Bauer Steven R2ORCID,Sarkar Sumona1ORCID

Affiliation:

1. Biosystems & Biomaterials Division, National Institute of Standards & Technology, Gaithersburg, MD 20899, USA

2. Division of Cellular & Gene Therapies, CBER, FDA, Silver Spring, MD 20993, USA

Abstract

Aim: Cell viability assays are critical for cell-based products. Here, we demonstrate a combined experimental and computational approach to identify fit-for-purpose cell assays that can predict changes in cell proliferation, a critical biological response in cell expansion. Materials & methods: Jurkat cells were systematically injured using heat (45 ± 1°C). Cell viability was measured at 0 h and 24 h after treatment using assays for membrane integrity, metabolic function and apoptosis. Proliferation kinetics for longer term cultures were modeled using the Gompertz distribution to establish predictive models between cell viability results and proliferation. Results & conclusion: We demonstrate an approach for ranking these assays as predictors of cell proliferation and for setting cell viability specifications when a particular proliferation response is required.

Funder

Food and Drug Administration

Publisher

Future Medicine Ltd

Subject

Embryology,Biomedical Engineering

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