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
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Online Access:https://hdl.handle.net/2134/37113
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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_ 1756598381578289152