基因治疗制品质量控制通用技术要求考虑要点  

General technical requirements for the quality control of gene therapy products

作　　者：史新昌[1] 秦玺[1] 于雷[1] 王光裕[1] 陶磊[1] 李响[1] 裴德宁[1] 李永红 周勇[1] SHI Xinchang;QIN Xi;YUE Lei;WANG Guangyu;TAO Lei;LI Xiang;PEI Dening;LI Yonghong;ZHOU Yong(Key Laboratory of the Ministry of Health for Research on Quality and standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 100050,China;Beijing Corregene Biotechnology Co.,Ltd.,Beijing 102206,China)

机构地区：[1]中国食品药品检定研究院,卫生部生物技术产品检定方法及其标准化重点实验室,北京100050 [2]北京可瑞生物科技有限公司,北京102206

出　　处：《中国药品标准》2022年第3期229-235,共7页Drug Standards of China

基　　金：国家质量基础设施体系专项(2021YFF0600804)。

摘　　要：本文旨在为基因治疗产品研发者开展制品研发和生产等活动提供必要质量控制原则,适用于以病毒为载体的基因治疗制品,也适用于溶瘤病毒类制品。本文通过借鉴类似制品成熟的、有效的、实用性被证明的策略和方法阐述基因治疗制品质量控制生物通用技术要求,希望对整个行业的发展提供帮助。基因治疗制品制造和质量控制应依照风险评估、全过程控制和全生命周期管理理念,以保障制品质量为最终目的,并通过对各个制造环节的控制实现制品的低安全风险的稳定生产。The purpose of this text is to provide necessary quality control principles for gene therapy product developers to carry out product research and development(R&D)and production activities.This text is applicable to gene therapy products with virus as carrier and oncolytic virus products.By referring to the mature,effective and practical strategies and methods of similar products,this critical point expounds the general biological technical requirements for the quality control of gene therapy products,hoping to provide help for the development of the whole industry.The manufacturing and quality control of gene therapy products should follow the concepts of risk assessment,whole process control and whole life cycle management,with the ultimate goal of ensuring the product quality,and realizing the low safety risk and stable production of products through the control of each manufacturing link.

关 键 词：基因治疗制品 病毒载体 生物制品生产 质量控制原则 通用技术要求 

分 类 号：R921.2[医药卫生—药学]