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.

中文翻译：

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CAR T细胞的临床制造：一种有前途的疗法的基础。

用表达嵌合抗原受体（CAR）的自体T细胞治疗癌症患者是最有前途的过继细胞治疗方法之一。可重复生产高质量的临床级CAR-T细胞产品是该技术广泛应用的先决条件。产品质量需要在制造过程的每个步骤中都内置。我们在此总结了要考虑的要求和物流以及可用的最先进的制造平台。CAR-T细胞疗法可能即将成为一些临床适应症的护理标准。然而，为了实现这种治疗方式的广泛使用和最终商业化，与制造标准化和产品表征有关的许多挑战仍有待克服。