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Manufacturing genetically modified T cells for clinical trials

Cancer Gene Therapy volume 22, pages 67–71 (2015)Cite this article

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Abstract

Compliance with Food and Drug Administration regulations relating to initiating early phase clinical trials of new cellular therapy products often presents a hurdle to new investigators. One of the biggest obstacles is the requirement to manufacture the therapeutic products under current Good Manufacturing Practices—a system that is usually poorly understood by both basic researchers and clinicians. This article reviews the major points that must be addressed when manufacturing genetically modified T cells for therapeutic use.

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Acknowledgements

This work was supported in part by the National Heart Lung and Blood contract ‘Production Assistance for Cellular Therapy’ Contract # HHSN26820100007C, by Grant RP130256 ‘Texas Assistance for Cancer Cell Therapy (TACCT)’ from Cancer Prevention and Research Institute of Texas, and by Grant 7001-14 ‘Immunotherapy for Hematologic Malignancies’ from the Leukemia and Lymphoma Society of America.

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  1. Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, Texas, USA

    A P Gee

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  1. A P Gee
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Correspondence to A P Gee.

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Gee, A. Manufacturing genetically modified T cells for clinical trials. Cancer Gene Ther 22, 67–71 (2015). https://doi.org/10.1038/cgt.2014.71

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