中国食品药品监管Issue(7)：88-93,6.DOI:10.3969/j.issn.1673-5390.2024.07.010
抗体类产品病毒安全控制探讨
Discussion on Viral Safety Control of Antibody Products
吕小红 1冯巧巧 1刘荣 1明奕 1胡敬峰1
作者信息
摘要
Abstract
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Key words
antibody products/viral safety control/cell banks/unprocessed bulk/virus removal or inactivation分类
医药卫生引用本文复制引用
吕小红,冯巧巧,刘荣,明奕,胡敬峰..抗体类产品病毒安全控制探讨[J].中国食品药品监管,2024,(7):88-93,6.
