单克隆抗体药物质量控制及HPLC分析技术

UltraSW Aggregate色谱柱改善单抗多聚体的回收率和分辨率(AN60)

   2014-08-14
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Introduction
Size exclusion chromatography (SEC) is well established for mAb aggregate analysis. As the technique has been used since the early days of mAb development for pharmaceutical purposes, various method improvements have evolved. The possibilities of mobile phase enhancement are often overlooked in SEC, since it is thought to leave less room for improvement when compared to other chromatographic conditions, such as particle size, packing quality and column length.

Once certain mobile phase parameters have been set, such as pH, stationary phase, and ionic strength, significant improvements can, in fact, be made to mAb aggregate separation by mobile phase additives. This application note will show how SEC analysis of mAb aggregate samples using a TSKgel® UltraSW Aggregate column are improved by amino acid additives in the mobile phase.

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编辑: gaowei2010    来源:丁香园