摘要
Abstract
This paper explores the key processes in the production of Antibody-Drug Conjugates(ADCs)and related research on GMP(Good Manufacturing Practice)inspections.It outlines the basic structure,mechanism of action,and production process flow of ADCs,including key steps such as the production of antibody intermediates,payload production,Linker-payload synthesis,ADC conjugation pro-duction,ADC purification,and formulation production.The article analyzes the current development status,market prospects,as well as the complexities and challenges in the production process of ADC drugs.It summarizes the GMP-related regulatory requirements for ADC drug production.On this basis,it elaborates in detail on the GMP inspection points for each key production link of ADC drugs,as well as the particularities of GMP requirements for ADC production.In view of the special GMP considerations in the production of ADC drugs,the article proposes technical difficulties,challenges,strategies,and suggestions for GMP inspections,aiming to provide references for quality management of ADC drug production enterprises and GMP inspections by regulatory agencies.关键词
抗体偶联药物/GMP检查/生产工艺/质量管理/监管机构Key words
Antibody-drug conjugates/GMP inspection/Production process/Quality management/Regulatory agencies分类
医药卫生
