我国单克隆抗体抗肿瘤药物研发流程研究

摘要

Objective To tease out the literature in the research and development stage of monoclonal antibody antitumor drugs and to sort out the research and development process of the monoclonal antibody antitumor drugs so as to lay the foundation for further identi-fying the risk factors, controlling and avoiding the risk in the research and development process of monoclonal antibody antitumor drugs. Methods The literature review method was adopted to conduct the arrangement analysis. Results The general process of re-search and development in monoclonal antibody antitumor drugs was summarized, including 5 parts of the target discovery and selection, antigen preparation, selection of monoclonal antibody preparation technique and antibody functional identification. The risk factors in each part were analyzed. Conclusion By summarizing the links of research and development of monoclonal antibody antitumor drugs and the risk factors in each link, the technical risks in the research and development process of monoclonal antibody antitumor drugs are pre-liminarily recognized, which can provide reference for the risk management of the research and development technique of monoclonal an-tibody antitumor drugs in future.%目的：通过梳理我国单克隆抗体（简称单抗）抗肿瘤药物研发阶段的文献，整理出单抗抗肿瘤药物研发流程，为进一步识别研发流程中的风险因素、控制和规避单克隆抗肿瘤药物的研发风险奠定基础。方法采用文献综述方法进行整理分析。结果总结出我国单抗抗肿瘤药物研发的一般流程，即靶点发现、靶点选择、抗原制备、单克隆抗体制备技术选择以及抗体功能鉴定5个部分，分析了各环节中存在的风险因素。结论通过对单抗抗肿瘤药研发环节的整理以及对各环节风险因素的总结，初步识别了抗肿瘤抗体药物研发过程中的技术风险，为以后单抗抗肿瘤药物研发技术的风险管理提供参考。