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- W2299937029 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." @default.
- W2299937029 created "2016-06-24" @default.
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- W2299937029 date "2016-04-01" @default.
- W2299937029 modified "2023-10-03" @default.
- W2299937029 title "Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization" @default.
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- W2299937029 doi "https://doi.org/10.2217/rme-2015-0034" @default.
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