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.Mahidol University2024-11-062024-11-062024-12-19Molecular Therapy Oncology Vol.32 No.4 (2024)https://repository.li.mahidol.ac.th/handle/20.500.14594/101893Anti-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.Biochemistry, Genetics and Molecular BiologyMedicineArticleSCOPUS10.1016/j.omton.2024.2008892-s2.0-8520770989029503299