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DOI: 10.3791/65488-v
Rene Machietto1, Nicholas Giacobbe1, Jessica Perazzelli2, Ted J. Hofmann2, Allison Barz Leahy2,3, Stephan A. Grupp1,2,3, Yongping Wang1,3,4, Stephan Kadauke1,3,4
1Cell and Gene Therapy Laboratory, Department of Pathology and Laboratory Medicine,Children’s Hospital of Philadelphia, 2Division of Oncology, Department of Pediatrics,Children’s Hospital of Philadelphia, 3Perelman School of Medicine at the University of Pennsylvania, 4Division of Transfusion Medicine, Department of Pathology and Laboratory Medicine,Children’s Hospital of Philadelphia
Please note that some of the translations on this page are AI generated. Click here for the English version.
This article details a semi-automated process for manufacturing chimeric antigen receptor T cells (CAR T-cells) for clinical use. The method utilizes an automated cell processor for viral transduction and cultivation, offering flexibility and cost-effectiveness compared to commercial alternatives.
本文详细介绍了临床使用的嵌合抗原受体T细胞的制造过程,特别是使用能够进行病毒转导和T细胞培养的自动化细胞处理器。我们提供建议并描述在早期临床试验的工艺开发和实施过程中应考虑的陷阱。
我们协议的优点是它是一个半自动化的封闭系统,仍然提供灵活性。劳动密集型步骤被自动化所取代,自动化由计算机运行,并且由于它由计算机运行,因此用户可以自定义其协议。这也是在一个封闭的系统中完成的。
我们发现,医院中常见的干细胞实验室能够以比商业替代品低得多的成本生产临床级CAR-T细胞。我们认为,我们的工艺可以很容易地用于使CAR-T细胞对其他靶点具有特异性,也可以用于制造其他类型的细胞和基因疗法。我们的团队准备探索其他CAR-T细胞靶点和新的基因疗法。
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