重组蛋白药物制品相关蛋白的分析与评价

我国的重组蛋白药物产业经过20多年的发展，建立了一套比较完备的质量控制体系，但是与国外发达国家相比，还存在一定的差距。随着技术的更新和进步，我国重组蛋白药物的质量控制技术也有待加强。2017年，国家药典委员会立项标准提高课题，主要针对重组细胞因子的制品相关蛋白展开研究。作为课题的一部分，本文对制品相关蛋白的分析与评价进行了介绍，内容包括制品相关蛋白的概念、国内外对制品相关蛋白的技术法规要求、制品相关蛋白的产生及其对产品质量的影响、制品相关蛋白的分析方法等。

After more than 20 years of development,the recombinant protein pharmaceutical industry in China has established a relatively complete quality control system,but there is still a gap compared with foreign developed countries. With the update and progress of technology,the quality control technology of recombinant protein drugs in China needs to be strengthened. In 2017,Chinese Pharmacopoeia Commission set up a project to improve the standards,which focuses on product-related proteins (PRPs) in recombinant cytokines. As part of the project,this article introduces the analysis and evaluation of PRPs,including the concept of PRPs,technical and regulatory requirements for PRPs at home and abroad,the production of PRPs and their effects on product quality,and analysis methods of PRPs,etc.