抗EGFR单克隆抗体表面电荷不均一性的分析条件优化

Optimization of Conditions for Analysis of Surface Charge Heterogeneity of Anti-EGFR Monoclonal Antibody

优化离子交换色谱法分析抗表皮生长因子受体(Epidermal growth factor receptor,EGFR)单克隆抗体表面电荷不均一性的条件。考察了离子交换色谱法分析抗EGFR单克隆抗体表面电荷不均一的条件,包括色谱柱、流动相pH、梯度及柱温。离子交换色谱法分析表面电荷不均一性的最佳条件:TSK-gelCM-STAT离子交换色谱柱、流动相pH6.0、合适的起始梯度及梯度陡度有利于电荷不均一性各组分的分离,柱温为40℃。合适的分析条件能够使单克隆抗体表面电荷不均一性各组分在离子交换色谱柱上得到最佳分离及获得较高灵敏度。

The analytical conditions of surface charge heterogeneity of anti-EGFR（epidermal growth factor receptor,EGFR）monoclonal antibody were optimized by ion exchange chromatography.The conditions,including column type,pH of mobile phase,gradient and column temperature,of surface charge heterogeneity of anti-EGFR monoclonal antibody were investigated by ion exchange chromatography.The optimal conditions of surface charge heterogeneity of anti-EGFR monoclonal antibody by ion exchange chromatography were as follows： column of TSK-gel CM-STAT,pH of mobile phase at 6.0,column temperature of 40℃,appropriate start gradient and gradient availed the separation of each component of charge heterogeneity.The suit analytical conditions can make the surface charge heterogeneity of anti-EGFR monoclonal antibody obtain the optimal separation and relative high sensitivity on ion exchange chromatography.