双特异性抗体药物细菌内毒素检查法的建立

Method Establishment of Bacterial Endotoxin Test in Therapeutic Bispecific Antibodies

内毒素大量存在于药物中会对人体造成严重的危害,对此,文章建立了双特异性抗体药物细菌内毒素的检测方法,并使用重组C因子法进行内毒素检测的方法学研究。结果显示,内毒素含量在0.1~2.5 EU/mL范围内时与荧光信号强度呈现出良好的线性关系;3种浓度下内毒素检测回收率范围在88%~120%以内;该方法的精密度和耐用性良好;重组C因子不与β-葡聚糖发生反应。该方法适用于双特异性抗体药物细菌内毒素的质量控制,打破了凝胶法检测的局限。

Endotoxins present in large quantities in drugs can cause serious harm to the human body.In this regard,the paper established a method for detecting bacterial endotoxins in bispecific antibody drugs and conducted methodological research on endotoxin detection using the recombinant C-factor method.The results showed that there was a good linear relationship between endotoxin content and fluorescence signal intensity within the range of 0.1 to 2.5 EU/mL;The recovery rate of endotoxin detection at three concentrations ranges from 88%to 120%;The precision and durability of this method are good;Recombinant C-factor does not matchβ-Dextran reacts.This method is suitable for the quality control of bacterial endotoxin of bispecific antibody drugs,and breaks the limitation of gel method.