重组蛋白类药物蛋白含量测定方法研究进展  

Research progress of methods for protein content determination in recombinant protein drugs

作　　者：曲耀成 姚雪静 QU Yaocheng;YAO Xuejing(RemeGen,Ltd.,Yantai 264006,Chi)

机构地区：[1]荣昌生物制药<烟台>有限公司,山东烟台264006

出　　处：《药学研究》2018年第3期174-177,共4页Journal of Pharmaceutical Research

摘　　要：如何实现蛋白药物的准确定量一直是生物技术药物质量控制中的重要课题。本文将蛋白含量测定方法系统地分成3类:标准定量法、比色分析法以及紫外吸收法,并对每种方法如何实现准确定量分别进行阐述。此外,本文还提出一种测定抗体药物偶联物中蛋白含量的方法,为该种重组蛋白类药物蛋白含量的准确测定提供了参考。How to realize the accurate quantification of protein drugs has been an important topic in the quality control of biotechnological drugs.In this paper,the methods of protein content determination are systematically divided into three categories:standard quantitative method,colorimetric analysis method and ultraviolet absorption method,and each method is discussed seperately about how to achieve accurate quantification.In addition,a method for the determination of protein content in antibody-drug conjugates was proposed,which provided a reference for the accurate determination of protein content in this recombinant protein drug.

关 键 词：蛋白含量 重组蛋白 抗体药物偶联物 消光系数 

分 类 号：R927.2[医药卫生—药学]