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Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India


Chimeric Antigen Receptor (CAR) T cell therapy is an accepted standard of care for relapsed/refractory B cell malignancies. However, the high cost of existing industry-driven centralized production makes this therapy unaffordable in low and middle-income countries. Decentralized or point of care manufacturing has the potential to overcome some of these challenges. Here we demonstrate a decentralized manufacturing process for anti-CD19-CAR-T cells using a fully automated closed system (Miltenyi CliniMACS Prodigy®) is feasible in a developing country setting. Validation run data, as part of a pre-clinical trial safety evaluation, demonstrates the successful and robust manufacturing of anti-CD19 CAR-T cells with T cell expansion of 25 to 47-fold. The median transduction efficiency was 48.8%, with a median viability of 98% and fulfillment of all standard release criteria assays for clinical application. Evaluation of production costs in an academic, not for profit setting in India provide a benchmark for low and middle-income pricing which could greatly increase access to this therapy. Based on our analysis, the cost per product would be approximately $35,107 US dollars. Our data highlights the safety, efficacy, and reproducibility of the process for use in planned future clinical trials.

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Fig. 1: Workflow of manufacturing CD19 CAR-T cells using CliniMACS Prodigy®.
Fig. 2: Characterization of anti-CD19 CAR-T cells manufactured using CliniMACS Prodigy® system.
Fig. 3: Immunophenotypic characterization of CAR-T cells and their differentiation status.
Fig. 4: Cytokine analysis of CAR-T cells exposed to target/non-target cells.
Fig. 5: CAR-T cells showed a potent antitumor activity in-vitro.
Fig. 6: Cost analysis per run for manufacturing CAR-T cells using CliniMACS Prodigy®.

Data availability

All data are available upon request.


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The authors thank Dr. Nedunchezhian, Cytocare Technologies, Bengaluru, India, for support in manufacturing CAR-T cells.


This study is supported by an Indian Council of Medical Research (ICMR) grant (91/06/2020-TFGTR/BMS), New Delhi, India.

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Authors and Affiliations



HKP, VM, BD, RO, JA conceived the study design. HKP, AKA, MY, AV, UK, SAL, SS, AK, AA, BG performed research, clinical data accrual and data analysis. HKP, VM, JA wrote the manuscript. All authors read and approved the manuscript.

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Correspondence to Vikram Mathews.

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Palani, H.K., Arunachalam, A.K., Yasar, M. et al. Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India. Bone Marrow Transplant 58, 160–167 (2023).

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