重组生物技术制品生产工艺变更的病毒安全性风险再评估策略  

Strategy for Viral Safety Risk Reassessment with Changes in the Manufacturing Process of Recombinant Biotechnology Products

作　　者：Wenbo Sai Dongchen Jia Hao Chen Wei Wei 

机构地区：[1]Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China

出　　处：《Engineering》2024年第1期14-17,共4页工程（英文）

摘　　要：In the manufacturing of biotechnology drug products,the viral safety control strategy is a critical pharmaceutical quality management framework that contains three key elements:prevention,testing,and clearance.The prevention strategy involves rigorous screening for any adventitious virus contamination in the raw materials,reagents,and endogenous/adventitious virus contamination in the cell banks.

关 键 词：PREVENTION TESTING REMOVE 

分 类 号：F42[经济管理—产业经济]