Cell therapies hold great therapeutic promise, but challenges remain in developing robust, scalable processes that are capable of meeting commercial lot sizes for high demand indications. We describe the development of a decisional tool to identify optimal technologies for varying production scales of allogeneic cell therapies. The tool integrates bioprocess economics with optimisation to assess the competitiveness of cell expansion (e.g. planar, microcarrier) and volume reduction (e.g. tangential flow filtration, single-use centrifugation) technologies. The cost implications of large volume, high cell density feedstreams on subsequent downstream processing steps are investigated so as to identify the most cost-effective integrated manufacturing strategies for commercially relevant lot sizes. Visualisation methods are used to identify current gaps in the technology capabilities and the productivities required to meet future lot sizes. The tool can facilitate early decision-making during process development and be used to lower the risk of process changes during a product's development cycle.

Tool to predict the economic benefit of alternative technologies used for the manufacture of allogeneic cell therapies at commercial scale

245th National Meeting (2013)

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