CAR-T细胞疗法的自动化设备及展望  

Current automatic devices and outlook for CAR-T cell therapy

作　　者：聂简琪 孙杨[1,2] 杨艳坤 戴晓峰[1,2] 刘秀霞 詹锦玲[1,2] 白仲虎 NIE Jianqi;SUN Yang;YANG Yankun;DAI Xiaofeng;LIU Xiuxia;ZHAN Jinling;BAI Zhonghu(National Engineering Laboratory for Cereal Fermentation Technology, Jiangnan University, Wuxi 214122, China;School of Biotechnology, Jiangnan University, Wuxi 214122, China)

机构地区：[1]江南大学粮食发酵工艺与技术国家工程实验室,无锡214122 [2]江南大学生物工程学院,无锡214122

出　　处：《生物产业技术》2017年第5期33-37,共5页Biotechnology & Business

基　　金：国家自然科学基金(31570034);国家重点基础研究发展计划(2013CB733602);国家高技术研究发展计划(2015AA020802);江苏省自然科学基金(BK20150148)

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 techniquein recent years.CAR-T cells are generated from the T cells of patients’or donations’peripheral blood,followed withactivation,genetically modification and expansion.CAR-T cells are washed and concentrated prior to reinfuse into thepatients.The modifi ed T cell with stronger tumor-orientated targeting ability and killing activity has achieved a remarkableeffect on the treatment of hematologic tumors and clinical trials of solid tumors.Quality control on the safety,sterilityand 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 forCAR-T and the problem for engineering,which could provide a reference for the CAR-T cell therapy engineering.

关 键 词：CAR-T细胞 细胞治疗 自动化设备 工程化 

分 类 号：R730.51[医药卫生—肿瘤]