Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization

Written by Regenerative Medicine

In this Regenerative Medicine research article, learn more about evaluating the impact of process change on drug development and commercialization. Approximately 40% of cell therapies in development are allogeneic and for most allogeneic cell therapy products in development or on the market, cell expansion is carried out using either planar technologies such as T-flasks or multilayer stacked vessels. Previous cost analyses have shown that microcarrier cultures offer cost of goods benefits that challenge the established position of planar technologies and, for large lot sizes, they are the only feasible technology option. This research article extends the cost of goods analyses...

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