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

Author:

Ayala Ceja Melanie1ORCID,Khericha Mobina1ORCID,Harris Caitlin M.1ORCID,Puig-Saus Cristina234ORCID,Chen Yvonne Y.1345ORCID

Affiliation:

1. University of California−Los Angeles 1 Department of Microbiology, Immunology, and Molecular Genetics, , Los Angeles, CA, USA

2. University of California−Los Angeles 2 Department of Medicine, , Los Angeles, CA, USA

3. Jonsson Comprehensive Cancer Center, University of California−Los Angeles 3 , Los Angeles, CA, USA

4. Parker Institute for Cancer Immunotherapy Center at University of California−Los Angeles 4 , Los Angeles, CA, USA

5. University of California−Los Angeles 5 Department of Chemical and Biomolecular Engineering, , Los Angeles, CA, USA

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.

Funder

California Institute for Regenerative Medicine

Parker Institute for Cancer Immunotherapy

Jean and Stephen Kaplan

Publisher

Rockefeller University Press

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