摘要
嵌合抗原受体(chimeric antigen receptor,CAR)T细胞疗法是近年来发展非常迅速的一种细胞治疗技术。通过从患者或者捐献者外周血分离获得T细胞,并进一步激活、基因修饰、扩增从而获得CAR-T细胞,洗涤浓缩后回输患者体内进行治疗。修饰后的T细胞肿瘤靶向性、杀伤活性更强,在血液肿瘤疾病临床试验中疗效明显,在实体瘤的临床试验中也崭露头角。CAR-T细胞疗法整个过程的安全性、无菌性、纯度等质量控制极其重要。确保CAR-T细胞疗法生产过程的标准化、封闭化与自动化,做到药效和风险可控是首要任务。对CAR-T细胞疗法工艺与自动化设备以及面临的工程化问题进行综述,以期为CAR-T细胞疗法工程化提供参考。
Chimeric antigen receptor(CAR)-T cell therapy has been a rapidly developing cell therapy technique in recent years. CAR-T cells are generated from the T cells of patients' or donations' peripheral blood, followed with activation, genetically modification and expansion. CAR-T cells are washed and concentrated prior to reinfuse into the patients. The modifi ed T cell with stronger tumor-orientated targeting ability and killing activity has achieved a remarkable effect on the treatment of hematologic tumors and clinical trials of solid tumors. Quality control on the safety, sterility and purity throughout the entire protocol is absolutely crucial. Therefore, the primary task is to ensure the standardization, closing and automation of CAR-T product process. This paper mainly reviewed the process and automatic devices for CAR-T and the problem for engineering, which could provide a reference for the CAR-T cell therapy engineering.
引文
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