CAR-T cell manufacturing: Major process parameters and next-generation strategies

Melanie Ayala Ceja; Mobina Khericha; Caitlin M Harris; Cristina Puig-Saus; Yvonne Y Chen

doi:10.1084/jem.20230903

CAR-T cell manufacturing: Major process parameters and next-generation strategies

J Exp Med. 2024 Feb 5;221(2):e20230903. doi: 10.1084/jem.20230903. Epub 2024 Jan 16.

Authors

Melanie Ayala Ceja¹, Mobina Khericha^#¹, Caitlin M Harris^#¹, Cristina Puig-Saus^{2

3

4}, Yvonne Y Chen^{1

3

4

5}

Affiliations

¹ Department of Microbiology, Immunology, and Molecular Genetics, University of California-Los Angeles, Los Angeles, CA, USA.
² Department of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.
³ Jonsson Comprehensive Cancer Center, University of California-Los Angeles , Los Angeles, CA, USA.
⁴ Parker Institute for Cancer Immunotherapy Center at University of California-Los Angeles , Los Angeles, CA, USA.
⁵ Department of Chemical and Biomolecular Engineering, University of California-Los Angeles, Los Angeles, CA, USA.

^# Contributed equally.

Abstract

Chimeric antigen receptor (CAR)-T cell therapies have demonstrated strong curative potential and become a critical component in the array of B-cell malignancy treatments. Successful deployment of CAR-T cell therapies to treat hematologic and solid cancers, as well as other indications such as autoimmune diseases, is dependent on effective CAR-T cell manufacturing that impacts not only product safety and efficacy but also overall accessibility to patients in need. In this review, we discuss the major process parameters of autologous CAR-T cell manufacturing, as well as regulatory considerations and ongoing developments that will enable the next generation of CAR-T cell therapies.

CAR-T cell manufacturing: Major process parameters and next-generation strategies

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Grants and funding