中国标准化Issue(24)：154-159,6.DOI:10.3969/j.issn.1002-5944.2024.24.021
浅析自动化封闭式细胞处理系统的模块化设计
Discussions on Modular Design of Automatic Closed Cell Processing System
摘要
Abstract
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.关键词
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Key words
automatic closed cell processing system/quality by design(QbD)/modularity/cell manufacturing/cellular therapy product/full lifecycle/critical quality attributes(CQA)/critical process parameters(CPP)引用本文复制引用
李婵,钟桂强,廖延..浅析自动化封闭式细胞处理系统的模块化设计[J].中国标准化,2024,(24):154-159,6.基金项目
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. （项目编号:KJZD20230923114504008）
