重组腺相关病毒(rAAV)基因治疗制品质控检验技术重点考量  

Critical considerations for quality control testing technology of recombinant adeno-associated virus(rAAV)gene therapy products

作　　者：秦玺[1] 于雷[1] 陶磊[1] 毕华[1] 王光裕[1] 史新昌[1] 周勇[1] QIN Xi;YU Lei;TAO Lei;BI Hua;WANG Guang-yu;SHI Xin-changg;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)

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试验室,北京100050

出　　处：《药物分析杂志》2023年第11期1811-1819,共9页Chinese Journal of Pharmaceutical Analysis

基　　金：国家质量基础设施资助(2021YFFO600804);北京市科学技术委员会资助(Z221100007922015)。

摘　　要：近些年,国内基因治疗行业迅速发展,创新制品不断涌现,如何对该类制品进行有效的质量控制成为业界十分关心的问题。本文借鉴基因治疗制品质量控制领域中相对成熟的、有效的、实用性被证明的方法,以重组腺相关病毒基因治疗制品为例,从检测项目与检测方法的选择、注意事项、质量标准的拟定等方面出发,阐述了其质量控制检验项目及相关技术要求。希望本文能为从业者开展该类制品的质量控制研究提供参考,并通过后续的交流讨论可达成一定共识,进而加速推动我国基因治疗行业的发展。In recent years,the domestic gene therapy industry has developed rapidly,and innovative gene therapy products are emerging constantly.How to effectively control the quality of such products has become a highly concerned issue in the industry.This article draws inspiration from relatively mature,effective,and practical methods in the field of quality control of gene therapy products.Taking recombinant adeno-associated virus gene therapy products as an example,starting from the selection of testing items and methods,precautions,and formulation of quality standards,it elaborates on their quality control inspection items and related technical requirements.We hope this article can provide reference for practitioners to conduct quality control research on such products,and through subsequent communication and discussion,a certain consensus can be reached,thereby accelerating the development of gene therapy industry in China.

关 键 词：基因治疗制品 重组腺相关病毒 检验检测 通用技术要求 

分 类 号：R917[医药卫生—药物分析学]