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Cost-effective bioprocess design for the manufacture of allogeneic CAR-T cell therapies using a decisional tool with multi-attribute decision-making analysis

Jenkins, MJ; Farid, SS; (2018) Cost-effective bioprocess design for the manufacture of allogeneic CAR-T cell therapies using a decisional tool with multi-attribute decision-making analysis. Biochemical Engineering Journal , 137 pp. 192-204. 10.1016/j.bej.2018.05.014. Green open access

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Abstract

Reimbursement pressures have resulted in an increased awareness of the importance of estimating and improving manufacturing costs for cell therapy products. This work describes the development and application of a decisional tool capable of computing the manufacturing costs for an allogeneic CAR-T cell bioprocess. The tool was used to facilitate a comparison of the impact on cost of goods (COG) from the use of different process technologies including T-flasks, gas permeable vessels, rocking motion bioreactors, an integrated processing platform, MACS purification and spinning membrane filtration technology. Seven different process flowsheets were compared and the economic drivers of manufacturing costs were analysed. COG per dose values were compared against a specified target selling price (TSP) to understand the feasibility of achieving a target COG as % TSP. Finally, a multi-attribute decision-making (MADM) analysis was conducted in order to allow preference of process design to be determined on the basis of qualitative and quantitative operational attributes, rather than COG alone. The flowsheet containing rocking motion bioreactors, spinning membrane filtration technology and a MACS purification platform was found to result in the lowest COG value. The MADM analysis indicated that this was also the preferred flowsheet when qualitative operational attributes were also considered. Furthermore, process attributes such as viral transduction efficiency and electroporation efficiency were found to be key process economic drivers.

Type: Article
Title: Cost-effective bioprocess design for the manufacture of allogeneic CAR-T cell therapies using a decisional tool with multi-attribute decision-making analysis
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.bej.2018.05.014
Publisher version: https://doi.org/10.1016/j.bej.2018.05.014
Language: English
Additional information: This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: Allogeneic CAR-T cells, Bioprocessing, Cell therapy, Bioprocess economics, Multi-attribute decision-making
UCL classification: UCL
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/10052826
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