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

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 cel...

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Main Authors:	Richard Harrison, Ezequiel Zylberberg, Simon Ellison, Bruce L. Levine
Format:	Default Article
Published:	2019
Subjects:	Mechanical engineering not elsewhere classified Cell therapy Chimeric antigen receptor Chimeric antigen receptor–T cells Manufacturing Offshoring Production management Logistics Supply chain Mechanical Engineering not elsewhere classified
Online Access:	https://hdl.handle.net/2134/37113
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id	rr-article-9567734
record_format	Figshare
spelling	rr-article-95677342019-02-13T00:00:00Z Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods Richard Harrison (2572996) Ezequiel Zylberberg (7214168) Simon Ellison (7214171) Bruce L. Levine (7214174) Mechanical engineering not elsewhere classified Cell therapy Chimeric antigen receptor Chimeric antigen receptor–T cells Manufacturing Offshoring Production management Logistics Supply chain Mechanical Engineering not elsewhere classified 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. 2019-02-13T00:00:00Z Text Journal contribution 2134/37113 https://figshare.com/articles/journal_contribution/Chimeric_antigen_receptor_T_cell_therapy_manufacturing_modelling_the_effect_of_offshore_production_on_aggregate_cost_of_goods/9567734 CC BY 4.0
institution	Loughborough University
collection	Figshare
topic	Mechanical engineering not elsewhere classified Cell therapy Chimeric antigen receptor Chimeric antigen receptor–T cells Manufacturing Offshoring Production management Logistics Supply chain Mechanical Engineering not elsewhere classified
spellingShingle	Mechanical engineering not elsewhere classified Cell therapy Chimeric antigen receptor Chimeric antigen receptor–T cells Manufacturing Offshoring Production management Logistics Supply chain Mechanical Engineering not elsewhere classified Richard Harrison Ezequiel Zylberberg Simon Ellison Bruce L. Levine Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
description	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.
format	Default Article
author	Richard Harrison Ezequiel Zylberberg Simon Ellison Bruce L. Levine
author_facet	Richard Harrison Ezequiel Zylberberg Simon Ellison Bruce L. Levine
author_sort	Richard Harrison (2572996)
title	Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
title_short	Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
title_full	Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
title_fullStr	Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
title_full_unstemmed	Chimeric antigen receptor–T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
title_sort	chimeric antigen receptor–t cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods
publishDate	2019
url	https://hdl.handle.net/2134/37113
_version_	1797098460920414208

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

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