Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India
| العنوان: | Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India |
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| المؤلفون: | Hamenth Kumar Palani, Arun Kumar Arunachalam, Mohammed Yasar, Arvind Venkatraman, Uday Kulkarni, Sharon Anbumalar Lionel, Sushil Selvarajan, Anu Korula, Aby Abraham, Biju George, Jennifer E. Adair, Rimas Orentas, Boro Dropulic, Vikram Mathews |
| المصدر: | Bone Marrow Transplantation. 58:160-167 |
| بيانات النشر: | Springer Science and Business Media LLC, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Transplantation, Hematology |
| الوصف: | 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. |
| تدمد: | 1476-5365 0268-3369 |
| DOI: | 10.1038/s41409-022-01866-5 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5e577764325cc4c5da7c618bd180ae75 https://doi.org/10.1038/s41409-022-01866-5 |
| Rights: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....5e577764325cc4c5da7c618bd180ae75 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14765365 02683369 |
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| DOI: | 10.1038/s41409-022-01866-5 |