浅析自动化封闭式细胞处理系统的模块化设计OACHSSCD
Discussions on Modular Design of Automatic Closed Cell Processing System
本文从政策导向、行业指南的规划方向入手,在"质量源自设计"的理念下,根据细胞治疗产品生产制备环节对设备的功能需求,探讨自动化封闭式细胞处理系统的模块化设计思路.并结合目前市场上已有设备的功能使用情况,讨论符合GMP要求的自动化封闭式细胞处理系统发展趋势.
This paper starts with the planning direction of policy orientation and industry guidelines,explores the concept of"quality by design",and discusses the modular design approach for automated closed cell processing system according to the functional requirements of equipment used in the production and preparation of cell therapy products.Furthermore,it probes into the functional utilization of existing equipment on the market,and discusses the development trend towards GMP-compliant automated closed cell processing systems.
李婵;钟桂强;廖延
深圳市北科生物科技有限公司
自动化封闭式细胞处理系统质量源自设计模块化细胞制备细胞治疗产品全生命周期关键质量属性关键工艺参数
automatic closed cell processing systemquality by design(QbD)modularitycell manufacturingcellular therapy productfull lifecyclecritical quality attributes(CQA)critical process parameters(CPP)
《中国标准化》 2024 (024)
154-159 / 6
本文受深圳市科技计划重大专项基金项目"间充质干细胞创新药物关键技术研发"(项目编号:KJZD20230923114504008)资助.
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