聚乙二醇化重组蛋白药物的质量控制

Quality Control for PEGylated Recombinant Protein

重组蛋白经聚乙二醇(PEG)化修饰在优化药物代谢动力学和药效学性质的同时,使药物的结构和质量属性变得更为复杂,修饰后的重组蛋白在结构、理化性质和生物学活性等方面与未修饰的重组蛋白相比有较大差异,对其质量控制的研究必须结合品种自身独特的质量属性。现从蛋白质药物质量控制的角度,对PEG化蛋白质药物的重要质量属性的质控难点和相应检测方法进行综述,以期对工艺开发和生产上的实际工作有所帮助。

Modified by polyethylene glycol, recombinant protein has better pharmacokinetic and pharmacodynamic properties while the structure and quality attributes become more complex. The modified recombinant protein has a big change in the structure, physical and chemical properties, and the biological activity. Therefore, it is important to consider the unique quality attributes of pegylated recombinant protein when researching the quality control. Difficulties of quality control and detection methods of important quality attributes of pegylated recombinant protein drugs are reviewed, to help future drug development and manufacturing process.