荧光素酶报告基因法测定生物制品活性研究进展  

Research progress in determination of activities of biological products by luciferase reporter gene assay

作　　者：贾小飞 梁明征 汤晓闯[1,2] 马素永 马杉姗[2] JIA Xiao-fei;LIANG Ming-zheng;TANG Xiao-chuang;MA Su-yong;MA Shan-shan(Beijing Naked Plasmid Gene Therapy Drug Engineering Technology Research Center,Beijing 100085,China;Beijing Northland Biotech.Co.,Ltd.,Beijing 100085,China)

机构地区：[1]北京市裸质粒基因治疗药物工程技术研究中心,北京100085 [2]北京诺思兰德生物技术股份有限公司,北京100085

出　　处：《军事医学》2023年第4期302-306,共5页Military Medical Sciences

摘　　要：生物学活性是反映生物制品药物有效性的关键质量属性,荧光素酶报告基因法利用报告基因的表达量反映药物的生物学活性,具有高效简便的优势,得到药品监管机构的认可。该文综述了荧光素酶报告基因法的技术原理、关键要素、分类及特征,归纳总结了其在生长因子、激素以及抗体等生物药活性测定方面的应用,可为生物药研发领域的科研人员提供参考。Biological activity is a key quality attribute that highlights the effectiveness of biologics drugs.Luciferase reporter gene assay uses the reporter gene expression to show the biological activity of drugs.Being highly efficient and userfriendly,this approach has been recognized by drug regulatory agencies.This paper outlines the technical principles,key elements,classification and characteristics of luciferase reporter gene assay,and summarizes its applications in the determination of biological activities of biologics drugs such as growth factors,hormones and antibodies.It is expected to provide reference for researchers in the field of biologics drugs.

关 键 词：荧光素酶 报告基因法 生物制品药物 生物学活性 

分 类 号：R392-33[医药卫生—免疫学]