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组织交叉反应是单克隆抗体类药物临床前安全性评价的重要组成部分。通过免疫组织化学方法考察单抗类药物与人体内非靶抗原的结合情况,为临床用药监测毒性提供参考。随着单克隆抗体研发由鼠源型向全人源化单抗的转变和发展,单抗药物的组织交叉反应试验也随之出现了一些问题,包括标本、组织选用、试验设计、抗体浓度选用和结果的综合分析等。本文结合笔者实际工作的经验和近年来国外组织交叉反应研究的情况,针对上述多方面问题进行了深入的探讨,以促进和推动我国单克隆抗体类药物的临床前安全性评价技术的发展。
Tissue cross-reactivity is an important part of the preclinical safety evaluation of monoclonal antibodies. By immunohistochemical method to examine the binding of monoclonal antibody and non-target antigen in human body, provide reference for clinical drug monitoring toxicity. With the development and transformation of murine monoclonal antibodies to fully humanized monoclonal antibodies, monoclonal antibody monoclonal antibody cross-reactivity tests also show some problems, including specimen selection, tissue design, experimental design and antibody concentration selection And the results of a comprehensive analysis. Based on the author’s practical experience and the cross-reactivity studies conducted by foreign organizations in recent years, this paper discusses in depth the various aspects mentioned above to promote and promote the development of preclinical safety evaluation techniques for monoclonal antibody drugs in our country.