Point-of-care manufacturing of anti-CD19 CAR-T cells using a closed production platform: Experiences of an academic in Thailand
Issued Date
2024-12-19
Resource Type
eISSN
29503299
Scopus ID
2-s2.0-85207709890
Journal Title
Molecular Therapy Oncology
Volume
32
Issue
4
Rights Holder(s)
SCOPUS
Bibliographic Citation
Molecular Therapy Oncology Vol.32 No.4 (2024)
Suggested Citation
Luanpitpong S., Klaihmon P., Janan M., Kungwankiattichai S., Owattanapanich W., Kunacheewa C., Chanthateyanonth S., Donsakul N., U-pratya Y., Warindpong T., Kittivorapart J., Permpikul P., Issaragrisil S. Point-of-care manufacturing of anti-CD19 CAR-T cells using a closed production platform: Experiences of an academic in Thailand. Molecular Therapy Oncology Vol.32 No.4 (2024). doi:10.1016/j.omton.2024.200889 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/101893
Title
Point-of-care manufacturing of anti-CD19 CAR-T cells using a closed production platform: Experiences of an academic in Thailand
Author's Affiliation
Corresponding Author(s)
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Abstract
Anti-CD19 chimeric antigen receptor (CAR)-T cell therapy has evolved as a standard of care for various forms of relapsed/refractory B cell malignancies in major developed countries. However, access to industry-driven CAR-T cell therapy is limited in developing countries, partly due to the centralized manufacturing system. Here, we demonstrated the feasibility of the point-of-care (POC) manufacturing of anti-CD19 CAR-T cells from heavily pretreated patients and healthy graft donors at an academic medical center in Thailand using a closed semi-automated production platform, CliniMACS Prodigy, and established in-process quality control and release testing to ensure their identity, purity, sterility, safety, and potency. Nine out of the nine products manufactured were used in a pilot study (ISRCTN17901467). However, we did observe that starting T cells with CD4/CD8 ratios of less than one-third had a high chance of manufacturing failure, which could be minimized by serum supplementation. Further analysis of T cell phenotypes in the infused versus circulating CAR-T cells revealed the differentiation from early memory subtypes toward effector cells in vivo. The POC manufacturing and quality control settings herein could be applied to other CAR-T cell products and may benefit other academics, especially those in developing countries, making CAR-T cells more accessible.