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1 Department of Haematology, Hospital Clinic of Barcelona, Barcelona, Spain
2 University College London Cancer Institute, London, UK
3 Medizinische Klinik (Krehl-Klinik), Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Rheumatologie, Innere Medizin V, Heidelberg, Germany
Book Affiliations
1 Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
2 Bart’s Cancer Institute, Queen Mary University of London, London, UK
3 Institut Paoli-Calmettes Comprehensive Cancer Center Aix-Marseille Université School of Medicine, Marseille, France
4 Maladies du Sang, Unité de Thérapie Cellulaire Centre hospitalier-Universitaire de Lille, Lille, France
5 Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Bayern, Germany
1 Department of Haematology, Hospital Clinic of Barcelona, Barcelona, Spain
2 University College London Cancer Institute, London, UK
3 Medizinische Klinik (Krehl-Klinik), Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Rheumatologie, Innere Medizin V, Heidelberg, Germany
Book Affiliations
1 Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
2 Bart’s Cancer Institute, Queen Mary University of London, London, UK
3 Institut Paoli-Calmettes Comprehensive Cancer Center Aix-Marseille Université School of Medicine, Marseille, France
4 Maladies du Sang, Unité de Thérapie Cellulaire Centre hospitalier-Universitaire de Lille, Lille, France
5 Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Bayern, Germany
CAR-T cells for clinical application are classified as advanced therapy medicinal products (ATMPs), and their manufacture is subject to laws and regulations governed by the European Medicines Agency (EMA) and by federal and regional authorities. CAR-T cells must be manufactured to achieve good manufacturing practice (GMP) compliance and are defined as potent products manufactured safely according to standardized methods under closely controlled, reproducible, and auditable conditions. BioPharma supplies the vast majority of CAR-T products for patients, but some academic centres have developed point-of-care cGMP CAR-T manufacturing capability, striving to uphold the same stringency of product quality while improving patient access to CAR-T cells and streamlining the costs of therapy. Point-of-care CAR-T manufacturing can only be performed in facilities with the appropriate regulatory approvals in place.
Castellà M, et al. Development of a novel anti-CD19 chimeric antigen receptor: a paradigm for an affordable CAR-T cell production at academic institutions. Mol Ther Methods Clin Dev. 2019;12:134–44.
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Castellá M, et al. Point-of-care CAR-T cell production (ARI-0001) using a closed semi-automatic bioreactor: experience from an academic phase I clinical trial. Front Immunol. 2020;11:482.
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Gong W, Hoffmann JM, Stock S, Wang L, Liu Y, Schubert ML, Neuber B, Hückelhoven-Krauss A, Gern U, Schmitt A, Müller-Tidow C, Shiku H, Schmitt M, Sellner L. Comparison of IL-2 vs IL-7/IL-15 for the generation of NY-ESO-1-specific T cells. Cancer Immunol Immunother. 2019;68(7):1195–209. Epub 2019 Jun 8. https://doi.org/10.1007/s00262-019-02354-4.
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Hoffmann J-M, Schubert M-L, Wang L, Hückelhoven A, Sellner L, Stock S, Schmitt A, Kleist C, Gern A, Loskog A, Wuchter A, Hofmann S, Ho AD, Müller-Tidow C, Dreger P, Schmitt M. Differences in expansion potential of naive chimeric antigen receptor T cells from healthy donors and untreated chronic lymphocytic leukemia patients. Front Immunol. 2018;8:1956. https://doi.org/10.3389/fimmu.2017.01956.
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Kunz A, Gern U, Schmitt A, Neuber N, Wang L, Hückelhoven-Krauss A, Michels B, Hofmann S, Müller-Tidow C, Dreger P, Schmitt M, Schubert M-L. Optimized assessment of qPCR-based vector copy numbers as a safety parameter for GMP-grade CAR-T cells and monitoring of frequency in patients. Mol Ther Methods Clin Dev. 2019;17:448–54.
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