抗体类产品病毒安全控制探讨  

Discussion on Viral Safety Control of Antibody Products

作　　者：吕小红 冯巧巧 刘荣 明奕 胡敬峰 LÜXiao-hong;FENG Qiao-qiao;LIU Rong;MING Yi;HU Jing-feng(Shandong Center for Food and Drug Evaluation and Inspection)

机构地区：[1]山东省食品药品审评查验中心

出　　处：《中国食品药品监管》2024年第7期88-93,共6页China Food & Drug Administration Magazine

摘　　要：病毒安全控制对于抗体类产品的生产质量至关重要。本文汇总了在药学审评及现场检查中抗体类产品在病毒安全控制方面的相关问题,结合最新修订的ICH Q5A(R2)指导原则、连续制造技术的发展情况以及平台化验证的技术要求,主要从厂房与仪器设备、细胞库、原材料与辅料及耗材、上游生产过程、下游纯化过程、变更控制等方面对抗体类产品病毒安全控制进行分析探讨,以期为相关生产企业及监管部门提供参考借鉴。Virus safety control is crucial for the production quality of antibody products.This article summarizes the relevant issues regarding virus safety control of antibody products in pharmaceutical reviews and on-site inspections.Based on the latest revised ICH Q5A(R2)guidelines,the development of continuous manufacturing technology,and the technical requirements for platform validation,this article analyzes and discusses the virus safety control of antibody products,covering aspects such as facilities and equipment,cell banks,raw materials,auxiliary materials and consumables,upstream production processes,downstream purification processes,change control,etc.,in order to provide references and guidance for relevant production enterprises and regulatory agencies.

关 键 词：抗体类产品 病毒安全控制 细胞库 未处理收获液 病毒去除或灭活 

分 类 号：R95[医药卫生—药学]