摘要
治疗性重组蛋白药物在我国经历了近30年的发展,分析技术的不断进步与质量标准的不断提高共同保证了我国重组蛋白药物的安全有效。由于重组蛋白药物本身的结构不稳定性及生产工艺复杂性,异质性成为其基本特性。异质性主要来源于工程菌/细胞的表达过程以及后续的生产储存过程,可能对产品的安全有效产生不利的影响。国际技术指南及各国药典均包含重组蛋白药物异质性分析的相关规定。随着技术的进步和发展,人们对重组蛋白药物异质性的分析能力也不断提高,对药物特性的理解也会更加深入。
Therapeutic recombinant protein drugs have experienced nearly 30 years of development in China. The continuous progress of analytical techniques and improvement of quality standards have jointly ensured their safety and effectiveness. Because of the structural instability of recombinant protein drugs and the complexity of production process,heterogeneity has become the basic characteristics of this kind of drugs. Heterogeneity mainly comes from the expression process of engineered bacteria/cells and the subsequent production and storage,which may exert adverse effects on the safety and effectiveness of the products. International Technical Guidelines and Pharmacopoeias in different countries all contain relevant regulations on the heterogeneity analysis of recombinant protein drugs. With the progress and development of technology,the ability to analyze the heterogeneity of recombinant protein drugs has been constantly improved,and the understanding of drug characteristics will be increasingly in-depth.
作者
陶磊
饶春明
王军志
TAO Lei;RAO Chun-ming;WANG Jun-zhi(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第21期2562-2565,共4页
Chinese Journal of New Drugs
基金
国家药典委员会药品标准制修订研究课题(2019S04):治疗性重组蛋白制品异质性分析方法的研究与建立
关键词
重组蛋白
异质性
评价
recombinant protein
heterogeneity
evaluation
