快速无菌检查方法在细胞和基因治疗产品中的应用及监管概述  

Application and regulation of rapid sterility test in cell and gene therapy products

作　　者：王诗琳 于玲莉 成殷 WANG Shilin;YU Lingli;CHENG Yin(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《上海医药》2022年第11期14-16,35,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：细胞和基因治疗产品是个体化产品,产量小、效期短,无菌检查需采用快速检查法。本文介绍细胞和基因治疗产品的快速无菌检查方法及其制造商在实际应用过程中可能会遇到的主要问题,供业界和监管部门参考。Cell and gene therapy products are individualized products with low yield and short shelf life.Rapid test is needed for sterility test.This article introduces the rapid sterility test of cell and gene therapy products and the main problems that the manufacturers may encounter in the actual application process so as to provide reference for the industry and regulatory authorities.

关 键 词：细胞治疗 快速微生物检查 无菌 

分 类 号：R951[医药卫生—药学] R927.1