中国食品药品监管Issue(5)：52-59,8.DOI:10.3969/j.issn.1673-5390.2025.05.005
我国实施抗体偶联药物分段生产的风险分析及监管对策思考
Risk Analysis and Regulatory Strategies for Divided Contract Manufacturing of Antibody-Drug Conjugates in China
蒋翠莺 1操桂兰 1谭敏 2徐云婷 1张乐一 1倪美华3
作者信息
- 1. 苏州工业园区药品管理中心
- 2. 国家药品监督管理局南方医药经济研究所
- 3. 苏州工业园区市场监督管理局
- 折叠
摘要
Abstract
Antibody-drug conjugate(ADC)products are a class of novel targeted biological products formed by conjugating a cytotoxic payload to an antibody or antibody fragment targeting specific to a target antigen via a chemical linker.ADC products have become a significant focus in oncology in recent years.Due to the complexity of their manufacturing processes,the divided contract manufacturing of ADC products has become increasingly necessary.This paper focuses on the manufacturing process of and potential risks associated with divided production,draws on international regulatory practices,and proposes regulatory strategies tailored to the Chinese context for managing divided contract manufacturing of ADC products.关键词
抗体偶联药物/生物制品/分段生产/生产工艺/风险/监管Key words
antibody-drug conjugate(ADC)/biological product/divided contract manufacturing/manufacturing process/risk/regulation分类
药学引用本文复制引用
蒋翠莺,操桂兰,谭敏,徐云婷,张乐一,倪美华..我国实施抗体偶联药物分段生产的风险分析及监管对策思考[J].中国食品药品监管,2025,(5):52-59,8.
