利用表面等离子体共振技术检测重组抗体NM57免疫原性-药学学报.PDF

532 药学学报 Acta Pharmaceutica Sinica 20 13, 48 (4): 532 535 用表面等离子体共振技术检测重组抗体NM57 免疫原性 1, 2† 1, 2† 1, 2 1, 2 1, 2 1, 2 亮 , 刘晓志 , 赵 伟 , 刘艳玲 , 董向峰 , 陈雪静 , 1, 2 1, 2 1, 2* 1, 2* 李立敏 , 蒋 艳 , 高 健 , 魏敬双 (华北制药集团 1. 新药研究开发有限责任公司, 2. 抗体药物研制国家重点实验室, 河北 石家庄 050015) 摘要: 随着生物技术药物的大量研发, 药物免疫原性评价成为阐明药物临床安全性和有效性的关键因素, 建立稳定可靠的评价体系成为了研究热点。由于具有实时、连续监测等优势, 表面等离子体共振 (surface plasmon resonance, SPR) 技术已被广泛用于生物药物免疫原性的评价。本研究中 用该技术对重组抗狂犬病毒人源单克 隆抗体NM57 Ⅰ期临床实验阶段接受注射的48 名志愿者进行抗药物抗体 (anti-drug antibody, ADA) 检测。结果 表明, 该检测方法可达到抗体药物免疫原性检测的基本要求。 关键词: 免疫原性; 表面等离子体共振; 重组狂犬病毒人源单克隆抗体 中图分类号: R392 文献标识码: A 文章编号: 0513-4870 (20 13) 04-0532-04 Testing immunogenicity of recombinant antibody by surface plasmon resonance CHANG Liang1, 2†, LIU Xiao-zhi 1, 2†, ZHAO Wei1, 2 , LIU Yan-ling1, 2, DONG Xiang-feng1, 2, CHEN Xue-jing 1, 2 , LI Li-min1, 2, JIANG Yan1, 2, GAO Jian1, 2*, WEI Jing-shuang 1, 2* (1. New Drug Research and Developmen t Compa ny Limited, 2. State Key Laboratory of Antibody Dr ug Development, North China Pharmaceutical Corporation, Shij iazhuang 050015, China ) Abstract : With the development of bio-technological drugs, drug immunogenicity evaluation has become key factor of clarifying safety and efficacy of these drugs. It has become the focus to establish a stable and reliable evaluation system. Due to the advantages such as continuous real-time monitoring, surface plasmon resonance (SPR) technology has been