生物技术药物免疫原性评价的技术发展概述  

Technology development of immunogenicity assessment for biopharmaceuticals

作　　者：黄瑛[1] 姜华[1] 李路路[1] 李伟[1] 王欣[1] 霍艳[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京100176

出　　处：《药物评价研究》2017年第7期999-1004,共6页Drug Evaluation Research

基　　金：十二五国家科技重大专项(2015ZX09501007-004);中国食品药品检定研究院中青年发展研究基金(2014C5)

摘　　要：药物的免疫原性是指药物刺激机体形成特异抗体或致敏淋巴细胞的性质。评价非期望的免疫原性是生物技术药物临床前和临床评价的重要内容。免疫原性评价内容包括方法的开发、验证、药物诱导的抗体反应水平检测(滴度)、抗体的特性研究、抗体的中和活性测定、分析抗体产生对疗效、毒性和药动学的影响,并预测对人体潜在的免疫原性强弱。如何提高动物模型的预测性、优化检测技术、实现评价方法的规范化和标准化,是未来免疫原性评价亟需解决的问题。The unwanted immunogenicity of biopharmaceutical is an adverse reaction caused by long-term medication. The primary concerns of immunogenicity would be critical for the efficacy and safety of biopharmaceutical. The immunogenicity assessments include validation of methodology, detection of anti-drug antibodies, characterization antibodies and their subtypes against biopharmaceuticals, determination of antibody neutralization as well as the analyses of relationship of antibody formation to pharmacokinetics and pharmacodynamics parameter and toxicities of drugs. The optimization of detection methods, the predictability of immunogenicity with available animal models and the standardization of evaluation method are currently the major challenges in the assessment of immunogenicity for biopharmaceuticals.

关 键 词：生物技术 药物评价 免疫原性 安全性评价 免疫原性评价 

分 类 号：R961[医药卫生—药理学]