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Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods

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journal contribution
posted on 11.03.2019, 10:00 by Richard Harrison, Ezequiel Zylberberg, Simon Ellison, Bruce L. Levine
Cell and gene therapies have demonstrated excellent clinical results across a range of indications with chimeric antigen receptor (CAR)–T cell therapies among the first to reach market. Although these therapies are currently manufactured using patient-derived cells, therapies using healthy donor cells are in development, potentially offering avenues toward process improvement and patient access. An allogeneic model could significantly reduce aggregate cost of goods (COGs), potentially improving market penetration of these life-saving treatments. Furthermore, the shift toward offshore production may help reduce manufacturing costs. In this article, we examine production costs of an allogeneic CAR-T cell process and the potential differential manufacturing costs between regions. Two offshore locations are compared with regions within the United States. The critical findings of this article identify the COGs challenges facing manufacturing of allogeneic CAR-T immunotherapies, how these may evolve as production is sent offshore and the wider implication this trend could have.

Funding

This study was supported by an Engineering and Physical Sciences Research Council (EPSRC) Engineering, Tissue Engineering and Regenerative Medicine (ETERM) Landscape fellowship grant (R.H.) reference EP/I017801/1.

History

School

  • Mechanical, Electrical and Manufacturing Engineering

Published in

Cytotherapy

Citation

HARRISON, R.P. ... et al, 2019. Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods. Cytotherapy, 21 (2), pp. 224-233.

Publisher

Elsevier © International Society for Cellular Therapy

Version

VoR (Version of Record)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Full details of this licence are available at: http://creativecommons.org/licenses/ by/4.0/

Publication date

2019-02-13

Notes

This is an Open Access article. It is published by Elsevier under the Creative Commons Attribution 4.0 International Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/

ISSN

1465-3249

Language

en

Licence

Exports