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Cited by 60CAR-T cell therapy researchImmunotherapy and Immune ResponsesT-cell and B-cell Immunology

Characterization of clinical grade CD19 chimeric antigen receptor T cells produced using automated CliniMACS Prodigy system

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Zhang, Wei, Jordan, Kimberly R, Schulte, Brian, Purev, Enkhtsetseg·2018·Drug Design, Development and Therapy
DOI 10.2147/dddt.s175113PMC PMC6181073
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Abstract

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy is highly effective for treating acute lymphoblastic leukemia and non-Hodgkin's lymphoma with high rate complete responses. However, the broad clinical application of CAR T-cell therapy has been challenging, largely due to the lack of widespread ability to produce and high cost of CAR T-cell products using traditional methods of production. Automated cell processing in a closed system has emerged as a potential method to increase the feasibility of producing CAR T cells locally at academic centers due to its minimal reliance on experienced labor, thereby making the process less expensive and more consistent than traditional methods of production. METHOD: In this study, we describe the successful production of clinical grade CD19 CAR T cells using the Miltenyi CliniMACS Prodigy Automated Cell Processor at University of Colorado Anschutz Medical Campus in a rapid manner with a high frequent CD19 CAR expression. RESULTS: The final CAR T-cell product is highly active, low in immune suppression, and absent in exhaustion. Full panel cytokine assays also showed elevated production of Th1 cytokines upon IL-2 stimulation when specifically killing CD19+ target cells. CONCLUSION: These results demonstrate the feasibility of producing CAR T cells locally in a university hospital setting using automated cell processor for future clinical applications.

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  • The CliniMACS Prodigy integrates all cell processing steps from T cell separation, CAR transduction, cell expansion, and formulation in a device using a single-use chamber and tubing set under GMP compliance.

    “To this end, we used a closed semi-automated platform, CliniMACS Prodigy, that integrates all cell processing steps from T cell separation, CAR transduction, cell expansion, and formulation in a device using a single-use chamber and tubing set under Good Manufacturing Practices (GMP) compliance.10,11”

    From Point-of-care manufacturing of anti-CD19 CAR-T cells using a closed production platform: Experiences of an academic in Thailand (2024) · cites this paper as [10]

    The Introduction describes Prodigy as a closed, largely automated device used to produce clinical-grade CAR T cells in a GMP facility. The Materials and methods section describes T-cell selection, transduction, expansion, and use of a Prodigy tubing set. Our copy does not establish that the chamber and tubing set are single-use or that formulation is performed in the device; it describes production in a GMP facility rather than establishing the device's GMP compliance. The indexed passages provide no page numbers. (LLM, conf=0.86)

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Cited by

Sorted by citations

Authors
Zhang, W., Jordan, K. R., Schulte, B., & Purev, E.
Affiliations
University of Colorado Anschutz (US)
Corresponding author
Purev, Enkhtsetseg
ORCID
Venue
Drug Design, Development and Therapy
Publisher
Informa UK Limited
Published
2018-10
Volume
Volume 12
Pages
3343-3356
ISSN
1177-8881 (ISSN-L)
DOI
10.2147/dddt.s175113
PMC
PMC6181073
OpenAlex
W2895040177
Cited by
60
References
4
Citations by year
2026: 9 · 2025: 9 · 2024: 5 · 2023: 4 · 2022: 6 · 2021: 9 · 2020: 10 · 2019: 8
FWCI
2.54
Type
journal article
Language
en
Open access
Licence
Locations
  • Drug Design Development and Therapy (publishedVersion, cc-by-nc)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
  • Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords
CD19 chimeric antigen receptor, CAR T-cell therapy, automated cell processing, CliniMACS Prodigy, acute lymphoblastic leukemia, non-Hodgkin lymphoma, T cell exhaustion, immunosuppression, Th1 cytokine response, cytokine release assay
MeSH terms
Receptors, Chimeric Antigen, Automation, Humans, Lymphoma, Non-Hodgkin, T-Lymphocytes, Cytokines, Immunotherapy, Adoptive, Antigens, CD19, Precursor Cell Lymphoblastic Leukemia-Lymphoma

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