Cell Therapy and Cell Engineering Facility, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Center for Cell Engineering, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Molecular Pharmacology Program, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
Mol Ther Oncolytics. 2016 Jun 15;3:16015. doi: 10.1038/mto.2016.15. eCollection 2016.
The treatment of cancer patients with autologous T cells expressing a chimeric antigen receptor (CAR) is one of the most promising adoptive cellular therapy approaches. Reproducible manufacturing of high-quality, clinical-grade CAR-T cell products is a prerequisite for the wide application of this technology. Product quality needs to be built-in within every step of the manufacturing process. We summarize herein the requirements and logistics to be considered, as well as the state of the art manufacturing platforms available. CAR-T cell therapy may be on the verge of becoming standard of care for a few clinical indications. Yet, many challenges pertaining to manufacturing standardization and product characterization remain to be overcome in order to achieve broad usage and eventual commercialization of this therapeutic modality.
用嵌合抗原受体 (CAR) 修饰的自体 T 细胞治疗癌症患者是最有前途的过继性细胞治疗方法之一。可重复性地生产高质量、临床级别的 CAR-T 细胞产品是该技术广泛应用的前提。产品质量需要内置在制造过程的每一个步骤中。我们在此总结了需要考虑的要求和物流,以及现有的先进制造平台。CAR-T 细胞疗法可能即将成为少数临床适应症的标准治疗方法。然而,为了实现这种治疗方式的广泛应用和最终商业化,仍有许多与制造标准化和产品特性相关的挑战需要克服。
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