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Cited by 637CAR-T cell therapy researchImmunotherapy and Immune ResponsesVirus-based gene therapy research

Clinical manufacturing of CAR T cells: foundation of a promising therapy

Open access
Wang, Xiuyan, Rivière, Isabelle·2016·Molecular Therapy - Oncolytics
DOI 10.1038/mto.2016.15PMC PMC4909095
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Abstract

The treatment of cancer patients with autologous T cells expressing a chimeric antigen receptor (CAR) is one of the most promising adoptive cellular therapy approaches. Reproducible manufacturing of high-quality, clinical-grade CAR-T cell products is a prerequisite for the wide application of this technology. Product quality needs to be built-in within every step of the manufacturing process. We summarize herein the requirements and logistics to be considered, as well as the state of the art manufacturing platforms available. CAR-T cell therapy may be on the verge of becoming standard of care for a few clinical indications. Yet, many challenges pertaining to manufacturing standardization and product characterization remain to be overcome in order to achieve broad usage and eventual commercialization of this therapeutic modality.

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  • Conventional CAR-T manufacturing involves many hands-on, manual operations and open steps in grade A laminar flow cabinets in a dedicated grade B cleanroom.

    “Conventional CAR-T manufacturing involves many hands-on, manual operations and open steps in grade A laminar flow cabinets in a dedicated grade B cleanroom.6,7”

    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 [6]

    The ‘Manufacturing CAR-T cells toward commercialization’ section says current platforms are labor intensive and identifies fully closed systems and automation as unmet needs. ‘Qualification of manufacturing facilities’ specifies GMP facilities with ISO5 cell-processing clean rooms, but the cited passages do not specify grade A laminar-flow cabinets, a dedicated grade B cleanroom, or where open steps occur. No page numbers are available in our copy. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

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Cited by

Sorted by citations

Authors
Wang, X., & Rivière, I.
Affiliations
Memorial Sloan Kettering Cancer Center (US)
Corresponding author
Rivière, Isabelle
ORCID
Venue
Molecular Therapy - Oncolytics
Publisher
Elsevier BV
Published
2016
Volume
3
Pages
16015
ISSN
2372-7705 (ISSN-L)
DOI
10.1038/mto.2016.15
PMC
PMC4909095
OpenAlex
W2443085751
Cited by
637
References
6
Citations by year
2026: 59 · 2025: 47 · 2024: 71 · 2023: 64 · 2022: 77 · 2021: 102 · 2020: 87 · 2019: 54 · 2018: 41 · 2017: 28 · 2016: 6 · 2013: 1
FWCI
4.33
Type
journal article
Language
en
Open access
Licence
Locations
  • Molecular Therapy — Oncolytics (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • U.S. Department of Defense
  • Starr Foundation
  • Juno Therapeutics
  • National Cancer Institute (P50CA086438, P30CA008748)
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
Keywords
CAR T-cell therapy, chimeric antigen receptor, production standardization, product quality, product characterization, manufacturing platforms, adoptive cellular therapy, autologous T cells, commercialization

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