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Updated: Jul 12, 2026
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Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor
Published on: August 18, 2023
Point-of-Care Manufacturing of Anti-CD19.1-Chimeric Antigen Receptor-T Cells Using CliniMACS Prodigy: Real-World
Khalid Halahleh1, Ahmad Abu-Khader2, Husam Abu-Jazar1
1Department of Internal Medicine, Adult Bone Marrow Transplantation and Cellular Therapy Program, King Hussein Cancer Center, Amman, Jordan.
JCO Global Oncology
|July 9, 2026
Summary
Decentralized manufacturing of chimeric antigen receptor (CAR)-T cells using the CliniMACS Prodigy system is feasible and reproducible in a developing country. This approach shows promise for treating relapsed refractory non-Hodgkin
Area of Science:
- Cellular immunotherapy
- Biotechnology
- Hematologic oncology
Background:
- Chimeric antigen receptor (CAR)-T cell therapy offers a promising treatment for hematologic malignancies.
- Traditional CAR-T cell manufacturing is complex, time-consuming, and resource-intensive, posing challenges for widespread adoption, especially in developing countries.
- Decentralized manufacturing models aim to streamline production and improve accessibility.
Purpose of the Study:
- To evaluate the feasibility and reproducibility of decentralized CAR-T cell manufacturing for relapsed refractory non-Hodgkin's lymphoma (rrNHL) patients.
- To assess the performance of an automated closed system (CliniMACS Prodigy) for CAR-T cell production in a developing country context (Jordan).
- To establish quality control standards for clinical-grade CAR-T cell products.
Main Methods:
- Peripheral blood mononuclear cells were collected and enriched for T cells.
- T cells were activated, transduced with an anti-MB-19.1-CAR lentiviral vector, and cultured on the automated CliniMACS Prodigy system.
- Rigorous quality control measures were implemented to ensure product identity, viability, purity, sterility, and potency.
Main Results:
- Eleven anti-CD19.1-CAR-T cell products were successfully manufactured with reproducible characteristics.
- Validation runs showed significant T-cell expansion (51-fold), high transduction efficiency (26%), and excellent viability (98%).
- Clinical-grade products demonstrated robust expansion (35-fold), 44% transduction efficiency, 99.8% viability, and met all quality standards within an average vein-to-vein time of 15.25 days. Early clinical data in eight patients showed objective responses and no new safety concerns.
Conclusions:
- Decentralized, automated manufacturing of anti-CD19.1-CAR-T cells is feasible and reproducible in a developing country.
- The CliniMACS Prodigy system facilitates point-of-care CAR-T cell production, potentially improving treatment accessibility for rrNHL patients.
- This approach holds significant promise for advancing CAR-T cell therapy in resource-limited settings.
