基于免疫细胞治疗产品生产技术探讨监管检查关注要点  

The Discussion of Regulatory Inspection Key Points Based on the Production Technology of Immune Cell Therapy Products

作　　者：董雪姣 郭林丰 郑天雷 张来俊[1] Dong Xuejiao;Guo Linfeng;Zheng Tianlei;Zhang Laijun(The Third Branch of Beijing Municipal Medical Products Administration,Beijing 100176,China)

机构地区：[1]北京市药品监督管理局第三分局,北京100176

出　　处：《中国药事》2024年第3期245-249,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:梳理免疫细胞治疗产品的开发以及监管检查文件依据,为此类产品的生产监管提供参考。方法:针对免疫细胞治疗产品的生产特点进行整理分析,介绍国内相关监管法规及指导意见,并对此类产品的生产现场检查面临的关键问题进行汇总分析,提出相关建议。结果与结论:细胞作为药品上市与传统药品相比具有多种独特的特性,因此在生产管理、质量控制、共线生产导致的系统污染风险等方面均存在挑战,本文从省级监管部门监管角度结合免疫细胞治疗产品的生产工艺,针对此类产品提出免疫细胞治疗产品现场检查关注重点及风险研判的建议,希望进一步完善免疫细胞治疗产品的上市后监管制度。Objective:To review and summarize the development and regulatory inspection documents of immune cell therapy products,and provide reference for the production and supervision of such products.Methods:The production characteristics of immune cell therapy products were organized and analyzed,and regulatory guidelines and reference documents in China were introduced,some key points that need to be taken into account by on-site inspections for this type of products were also summarized.Results and Conclusion:Compared with traditional drugs,cells as drug have multiple unique characteristics.Therefore,there are challenges in production management,quality control,and systemic contamination risks caused by diff erent products to be produced on the same line.This article proposes suggestions for on-site inspection and risk assessment of immune cell therapy products from the perspective of provincial regulatory authorities,combined with the production process of immune cell therapy products.We hope to further improve the post-marketing supervision system of immune cell therapy products.

关 键 词：免疫细胞治疗产品 生产监管 技术 法规 现场检查要点 

分 类 号：R95[医药卫生—药学]