Dias, J;
Garcia, J;
Agliardi, G;
Roddie, C;
(2024)
CAR-T cell manufacturing landscape—Lessons from the past decade and considerations for early clinical development.
Molecular Therapy Methods and Clinical Development
, 32
(2)
, Article 101250. 10.1016/j.omtm.2024.101250.
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Abstract
CAR-T cell therapies have consolidated their position over the last decade as an effective alternative to conventional chemotherapies for the treatment of a number of hematological malignancies. With an exponential increase in the number of commercial therapies and hundreds of phase 1 trials exploring CAR-T cell efficacy in different settings (including autoimmunity and solid tumors), demand for manufacturing capabilities in recent years has considerably increased. In this review, we explore the current landscape of CAR-T cell manufacturing and discuss some of the challenges limiting production capacity worldwide. We describe the latest technical developments in GMP production platform design to facilitate the delivery of a range of increasingly complex CAR-T cell products, and the challenges associated with translation of new scientific developments into clinical products for patients. We explore all aspects of the manufacturing process, namely early development, manufacturing technology, quality control, and the requirements for industrial scaling. Finally, we discuss the challenges faced as a small academic team, responsible for the delivery of a high number of innovative products to patients. We describe our experience in the setup of an effective bench-to-clinic pipeline, with a streamlined workflow, for implementation of a diverse portfolio of phase 1 trials.
Type: | Article |
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Title: | CAR-T cell manufacturing landscape—Lessons from the past decade and considerations for early clinical development |
Open access status: | An open access version is available from UCL Discovery |
DOI: | 10.1016/j.omtm.2024.101250 |
Publisher version: | http://dx.doi.org/10.1016/j.omtm.2024.101250 |
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 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: | Chimeric antigen receptors, immunotherapy, manufacturing, automation, quality control |
UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Haematology |
URI: | https://discovery.ucl.ac.uk/id/eprint/10192475 |
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