常 亮 刘晓志 赵 伟 刘艳玲 董向峰 陈雪静 李立敏 蒋 艳 高 健 魏敬双. 利用表面等离子体共振技术检测重组抗体NM57免疫原性J. 药学学报, 2013,48(4): 532-535.
引用本文: 常 亮 刘晓志 赵 伟 刘艳玲 董向峰 陈雪静 李立敏 蒋 艳 高 健 魏敬双. 利用表面等离子体共振技术检测重组抗体NM57免疫原性J. 药学学报, 2013,48(4): 532-535.
CHANG Liang, LIU Xiao-Zhi, ZHAO Wei, LIU Yan-Ling, DONG Xiang-Feng, CHEN Xue-Jing, LI Li-Min, JIANG Yan, GAO Jian, WEI Jing-Shuang. Testing immunogenicity of recombinant antibody by surface plasmon resonanceJ. 药学学报, 2013,48(4): 532-535.
Citation: CHANG Liang, LIU Xiao-Zhi, ZHAO Wei, LIU Yan-Ling, DONG Xiang-Feng, CHEN Xue-Jing, LI Li-Min, JIANG Yan, GAO Jian, WEI Jing-Shuang. Testing immunogenicity of recombinant antibody by surface plasmon resonanceJ. 药学学报, 2013,48(4): 532-535.

利用表面等离子体共振技术检测重组抗体NM57免疫原性

Testing immunogenicity of recombinant antibody by surface plasmon resonance

  • 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。本研究中应用该技术对重组抗狂犬病毒人源单克隆抗体NM57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。

     

    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 widely used in bio-technological drugs immunogenicity assessments.  Our study applied this technology to detect anti-drug antibody (ADA) of a recombinant human anti-rabies monoclonal antibody NM57 in the sera of 48 volunteers admitted in phase I clinical trials.  This method could satisfy the basic requirements of detection of ADA.

     

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