狂犬病病毒中和单抗表位鉴定和中和广谱性评价研究进展  

Progress in Epitope Mapping and Evaluation of Neutralization Spectrum of Neutralizing Monoclonal Antibody against Rabies

作　　者：王文波[1] 于传飞[1] 王兰[1] Virus Wang Wenbo;Yu Chuanfei;Wang Lan(National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定及标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《中国药事》2023年第10期1172-1179,共8页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划蛋白类生物制品主成分及其相关成分精准定量检测技术研究(编号2021YFF0600804)。

摘　　要：目的:对狂犬病病毒(RABV)中和单抗的研发进展及其表位和中和广谱性研究评价进行综述,为行业提供参考。方法:通过文献检索,对国内外开展的狂犬病病毒中和单抗研究进行梳理和汇总。结果与结论:中和抗体在狂犬病暴露后预防中发挥着重要的作用,目前国内外已有多个RABV单抗品种上市并有多个品种处于临床评价阶段。RABV具有较高的突变频率且感染发病后致死率极高,为了最大程度地中和自然流行的RABV病毒株,以防止感染后狂犬病的发生,在单抗候选药物研发时应对其表位和广谱性进行充分的研究评价。Objective:To review the research and development progress of neutralizing monoclonal antibody(mAb)against rabies virus(RABV),as well as its epitope mapping and evaluation of neutralization spectrum,in order to provide references for the industry.Methods:Through literature retrieval,the research on anti-RABV mAbs both domestically and internationally was summarized.Results and Conclusion:Neutralizing antibodies against RABV play an important role in post exposure prophylaxis(PEP).At present,there are several anti-RABV mAbs been approved or at clinical trails both domestically and internationally.RABV has high mutation rate,and has almost 100%mortality rate once clinical symptoms appear after infection.To maximize the neutralization activity against naturally circulating RABV strains and avoid fatal rabies,the epitope and neutralization spectrum of anti-RABV mAb candidates should be carefully studied during research and development stage.

关 键 词：单抗 狂犬病病毒 表位鉴定 中和广谱性 

分 类 号：R917[医药卫生—药物分析学]