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Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization
Sally Hassan1, Hsini Huang2, Kim Warren3
1Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Gordon Street, London, WC1H 0AH, UK.
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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