【摘要】 近年来细胞治疗技术飞速发展，其中，嵌合抗原受体T细胞免疫疗法（Chimeric Antigen Receptor T Cell Immunotherapy, CAR-T）治疗恶性肿瘤潜力巨大。但细胞制备工艺十分复杂、制造成本高昂，且手动生产工艺因开放性会导致潜在污染风险和批次质量差异，急需开发全封闭、自动化的CAR-T细胞生产设备。根据CAR-T细胞制备工艺流程，开发了一套符合药品生产质量管理规范（Good Manufacturing Practice of Medical Products, GMP）的全封闭、自动化的CAR-T细胞制备与监控系统。该系统由管路模块（反应器、一次性管路、试剂袋）、机电控制模块（夹管阀、蠕动泵、电机、磁铁转位机构）和培养环境核心参数（温度、pH、CO₂浓度、溶解氧（Dissolved Oxygen, DO）浓度）监控模块，以及辅助系统模块构成；细胞制备过程可溯源。实验证明该系统具备T细胞分离、免疫磁珠分选、物料自动定量添加、培养环境在线监控、细胞收集等功能。更多还原

【Abstract】 In recent years, cell therapy technologies have developed rapidly. Among them, chimeric antigen receptor T（CAR-T） cell Immunotherapy has significant potential in the treatment of malignant tumors. However, the cell preparation process of CAR-T is complicated, the manufacturing cost is high, and the openness of the manual preparation process will lead to potential contamination risks and batch quality differences. There is an urgent need to develop fully closed and automated CAR-T cell preparation systems. In this paper, according to the CAR-T cell preparation process, a fully closed and automated CAR-T cell preparation and monitoring system in compliance with Good Manufacturing Practice（GMP） of medical products is developed. The system consists of a pipeline module（including a reactor, disposable pipelines and reagent bags）, an electromechanical control module（including pinch valves, a peristaltic pump, a motor and a magnet transposition mechanism）, a monitoring module for core parameters（e.g. temperature, pH, CO₂ concentration, dissolved oxygen concentration） of the culture environment and an auxiliary system module. The process of cell preparation can be traced. Experiments have proved that the system can achieve T cell separation, immunomagnetic bead sorting, automatic quantitative addition of materials, online monitoring of culture environment and cell collection.更多还原