Simaria, AS; Hassan, S; Varadaraju, H; Rowley, J; Warren, K; Vanek, P; Farid, SS; (2014) Allogeneic cell therapy bioprocess economics and optimisation: Single-use cell expansion technologies. Biotechnol Bioeng , 111 (1) pp. 69-83. 10.1002/bit.25008.

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Abstract

For allogeneic cell therapies to reach their therapeutic potential, challenges related to achieving scalable and robust manufacturing processes will need to be addressed. A particular challenge is producing lot-sizes capable of meeting commercial demands of up to 10(9) cells per dose for large patient numbers due to the current limitations of expansion technologies. This paper describes the application of a decisional tool to identify the most cost-effective expansion technologies for different scales of production as well as current gaps in the technology capabilities for allogeneic cell therapy manufacture. The tool integrates bioprocess economics with optimisation to assess the economic competitiveness of planar and microcarrier-based cell expansion technologies. Visualisation methods were used to identify the production scales where planar technologies will cease to be cost-effective and where microcarrier-based bioreactors become the only option. The tool outputs also predict that for the industry to be sustainable for high demand scenarios, significant increases will likely be needed in the performance capabilities of microcarrier-based systems. This data is presented using a technology S-curve as well as windows of operation to identify the combination of cell productivities and scale of single-use bioreactors required to meet future lot sizes. The modelling insights can be used to identify where future R&D investment should be focused to improve the performance of the most promising technologies to help ensure that they become a robust and scalable option to enable the cell therapy industry reach commercially relevant lot sizes. The tool outputs can facilitate decision-making very early on in development and be used to predict, and better manage, the risk of process changes needed as products proceed through the development pathway. Biotechnol. Bioeng. © 2013 Wiley Periodicals, Inc.

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