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

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.