Hassan, S; Huang, H; Warren, K; Mahdavi, B; Smith, D; Jong, S; Farid, SS; (2016) Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization. Regenerative Medicine , 11 (3) pp. 287-305. 10.2217/rme-2015-0034.

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Abstract

AIMS: Some allogeneic cell therapies requiring a high dose of cells for large indication groups demand a change in cell expansion technology, from planar units to microcarriers in single-use bioreactors for the market phase. The aim was to model the optimal timing for making this change. MATERIALS & METHODS: A development lifecycle cash flow framework was created to examine the implications of process changes to microcarrier cultures at different stages of a cell therapy's lifecycle. RESULTS: The analysis performed under assumptions used in the framework predicted that making this switch earlier in development is optimal from a total expected out-of-pocket cost perspective. From a risk-adjusted net present value view, switching at Phase I is economically competitive but a post-approval switch can offer the highest risk-adjusted net present value as the cost of switching is offset by initial market penetration with planar technologies. CONCLUSION: The framework can facilitate early decision-making during process development.

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