单克隆抗体类生物制品关键质量属性  

Critical quality attributes of monoclonal antibody-based biological products

作　　者：景荣先 曾媛 张国林 JING Rongxian;ZENG Yuan;ZHANG Guolin(Pharmacy Department,the Affiliated Suzhou Hospital of Nanjing Medical University,Suzhou Municipal Hospital,Jiangsu,Suzhou 215002,China;China Drug Research and Development Department,Clinical Pharmacology Department,Pfizer(China)Research and Development Co.,Ltd.,Shanghai 201203;Suzhou Institute for Drug Control,Jiangsu,Suzhou 215104,China)

机构地区：[1]南京医科大学附属苏州医院苏州市立医院药学部,江苏苏州215002 [2]辉瑞(中国)研究开发有限公司中国药物研发部临床药理部,上海201203 [3]苏州市药品检验检测研究中心,江苏苏州215104

出　　处：《中国医药科学》2023年第18期177-180,共4页China Medicine And Pharmacy

基　　金：江苏省市场监督管理局科技计划项目(KJ2023061);江苏省苏州市科技计划项目(SYS2020199)。

摘　　要：分析单克隆抗体(mAb)类生物制品关键质量属性(CQAs)及影响其杂质检测结果准确性、可靠性的因素。依据mAb类药物的特点及目标产品质量概况(QTPP)分析其关键质量属性。质量属性可分为关键的和非关键的:质量属性是否作为CQAs主要通过评价其超出可接受范围时对产品安全性和有效性的影响程度。mAb类药物CQAs包括等电点、单体、大小变异体、电荷变异体、N-糖基化修饰、唾液酸含量、生物学活性等。研究mAb类生物制品CQAs、分析其杂质检测结果准确可靠的影响因素对产品治疗控制和临床用药安全具有重要的价值。To analyze the critical quality attributes(CQAs)of monoclonal antibody(mAb)based biological products and the factors that affect the accuracy and reliability of impurity detection results.Analyze the critical quality attributes of mAb drugs based on their characteristics and quality target product profile(QTPP).Quality attributes can be divided into critical and noncritical:whether quality attributes are considered CQAs mainly depends on evaluating their impact on product safety and effectiveness when they exceed the acceptable range.CQAs of mAb drugs include isoelectric points,monomers,size heterogeneities,charge heterogeneities,N-glycosylation modifications,sialic acid content,biological activity,etc.Studying the CQAs of mAb biological products and analyzing the factors that affect the accuracy and reliability of impurity detection results are of great value for product treatment control and clinical medication safety.

关 键 词：单克隆抗体 杂质 质量 准确性 稳定性 

分 类 号：R927.1[医药卫生—药学]