肿瘤细胞治疗研究
英文原题：Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India.
中位转导效率为48.8%，中位活力为98%，并满足所有临床应用的标准放行检测要求。
嵌合抗原受体（CAR）T细胞疗法是复发/难治性B细胞恶性肿瘤公认的标准治疗。然而，现有产业驱动的集中化生产的高成本使得该疗法在低收入和中等收入国家难以负担。分散式或即时生产有可能克服其中一些挑战。在此，我们证明在发展中国家环境下，使用全自动封闭系统（Miltenyi CliniMACS Prodigy）进行抗CD19-CAR-T细胞的分散式生产工艺是可行的。作为临床前试验安全性评估的一部分，验证运行数据表明，抗CD19 CAR-T细胞能够成功且稳健地生产，T细胞扩增25至47倍。中位转导效率为48.8%，中位活力为98%，并满足临床应用的所有标准放行检测要求。在印度学术性、非营利环境下对生产成本进行的评估，为低收入和中等收入定价提供了基准，这可能极大地提高该疗法的可及性。根据我们的分析，每份产品的成本约为35,107美元。我们的数据凸显了该工艺用于计划中的未来临床试验的安全性、有效性和可重复性。
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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