Division of Medical Oncology, Department of Medicine, and Department of Stem Cell Biology and Regenerative Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California.
Joint USC/CHLA Cell Therapy Program, University of Southern California, and Children's Hospital Los Angeles, Los Angeles, California.
Blood Cancer Discov. 2021 Sep;2(5):408-422. doi: 10.1158/2643-3230.BCD-21-0084. Epub 2021 Aug 3.
UNLABELLED: As of April 2021, there are five commercially available chimeric antigen receptor (CAR) T cell therapies for hematological malignancies. With the current transition of CAR T cell manufacturing from academia to industry, there is a shift toward Good Manufacturing Practice (GMP)-compliant closed and automated systems to ensure reproducibility and to meet the increased demand for cancer patients. In this review we describe current CAR T cells clinical manufacturing models and discuss emerging technological advances that embrace scaling and production optimization. We summarize measures being used to shorten CAR T-cell manufacturing times and highlight regulatory challenges to scaling production for clinical use. STATEMENT OF SIGNIFICANCE ∣: As the demand for CAR T cell cancer therapy increases, several closed and automated production platforms are being deployed, and others are in development.This review provides a critical appraisal of these technologies that can be leveraged to scale and optimize the production of next generation CAR T cells.
未加标签:截至 2021 年 4 月,已有五种用于血液系统恶性肿瘤的商业上可获得的嵌合抗原受体(CAR)T 细胞疗法。随着 CAR T 细胞制造从学术界向工业界的当前转变,正在向符合良好生产规范(GMP)的封闭和自动化系统转移,以确保重现性并满足癌症患者需求的增加。在这篇综述中,我们描述了当前的 CAR T 细胞临床制造模型,并讨论了采用规模化和生产优化的新兴技术进步。我们总结了用于缩短 CAR T 细胞制造时间的措施,并强调了规模化生产用于临床应用的监管挑战。
意义声明:随着对 CAR T 细胞癌症疗法的需求增加,正在部署几种封闭和自动化生产平台,还有其他平台正在开发中。本综述对这些可用于规模化和优化下一代 CAR T 细胞生产的技术进行了批判性评估。
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