摘要
免疫原性是影响生物技术药物安全性和有效性的重要因素。近年来,关于生物技术药物的免疫原性评价越来越受到重视,但国内仍缺乏免疫原性评价相关的指导原则,可供参考的资料较少。因此,在药物研发和评价过程中,各单位进行免疫原性评价的方法和操作方式都不尽相同。本文参考了美国食品药品监督管理局和欧盟药物管理局最新的相关指导原则和国外业内的一些白皮书,结合本单位的相关经验,对非临床生物技术药物免疫原性分析的检测步骤,自然样本群的选择,对照样本的选择,临界值的计算及其他如灵敏度、特异性、选择性、精密度的确定和生物类似药免疫原性对比等进行探讨。
Immunogenicity is an important factor that influences the safety and efficacy of biotechnology products.Recently,the immunogenicity evaluation of biopharmaceuticals has draw increasing attention.Although American Food and Drug Administration(FDA)and European Medicines Agency(EMA)have issued guidelines on immunogenicity assessment,they are lacking in China,and there are not enough references,which can lead to the inconsistency of methods used in immunogenicity validation by different companies.Different parts of method validation,including detection steps,selection of natural samples,selection of control samples,determination of cut points,sensitivity,specificity and selectivity,precision,and immunogenicity of biosimilar drugs are discussed based on relevant guidelines issued by FDA and EMA,white papers and experience of our company.
作者
任欣怡
朱晰
张代超
陈探
程远国
赵小平
车津晶
REN Xin-yi;ZHU Xi;ZHANG Dai-chao;CHEN Tan;CHENG Yuan-guo;ZHAO Xiao-ping;CHE Jin-jing(Shanghai InnoStar Bio-tech Co.Ltd,Shanghai 201203,China;State Key Laboratory of oxicology and Medical Countermeasures,Beijing Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Academy of Military Science,Beijing 100850,China)
出处
《中国药理学与毒理学杂志》
CAS
CSCD
北大核心
2018年第11期902-906,共5页
Chinese Journal of Pharmacology and Toxicology
基金
国家科技重大专项(2015ZX09501007-003)
上海市科委工程技术中心项目(17DZ2252900)
浦东CRO项目(PKF2014-C01).
关键词
免疫原性
生物技术药物
方法学验证
immunogenicity
biotechnology products
method validation
