基因重组药物蛋白类杂质检测及质量控制

The test and quality control of protein impurity in gene recombination drugs

生物技术药物中蛋白类杂质是最普通、最复杂也是最具潜在危害性的杂质,去除生物药品中所有蛋白杂质也是不可能的.为增加产品安全性必须加强对生物制品中蛋白类杂质的质量控制.目前对生物技术药物蛋白类杂质检测及质量控制方法包括:免疫学分析、凝胶电泳、等电聚焦电泳、二维电泳及质谱技术、毛细管电泳、高效液相色谱等.将生物药品中相关蛋白类杂质控制在合理范围内,既可增加用药安全性,又能增强药物生物学活性,是该类药品成功应用于临床的必然要求.

Protein impurity is the most common,complex and potentially harmful impurity in bio-technological drugs.Although it is not practical to get rid of all protein impurities in bio-technological drugs,the quality control must be enhanced for the purpose to increase the safety of drugs.Current methods of test and quality control toward protein impurity in bio-technological drugs mainly include immunological analysis,GE（gel electrophoresis）,IFE（isoelectric focusing electrophoresis）,2-DE（two dimensional electrophoresis）,MS（mass spectrometry）,CE（capillary electrophoresis）,HPLC（High Performance Liquid Chromatography）,etc.It is necessary for the successful clinical application of bio-technological drugs to control the protein impurity within an acceptable range,not only because the safety of drugs can be increased,but the biological activity of drugs can be improved.