预防类生物药品含量测定>色谱法检测 | Native SEC/MS Analysis of mAbs on an Entirely Biocompatible Flow Path-安捷伦科技(中国)有限公司

方案摘要

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应用领域	制药/生物制药
检测样本	预防类生物药品
检测项目	含量测定>色谱法
参考标准	/

Using the Agilent 1290 Infinity II Bio LC System and Agilent AdvanceBio SEC 200 Å 1.9 μm PEEK-lined column in mAbs analysis

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Agilent 1290 Infinity II 生物液相色谱系统
型号：1290 Infinity II Bio LC

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方案详情

Size exclusion chromatography (SEC) of recombinant therapeutic proteins, such as monoclonal antibodies (mAbs), is an essential analytical tool to detect the presence of size variants, which may have adverse effects on safety and efficacy. SEC is commonly carried out using nonvolatile phosphate buffers, which makes the separation incompatible with mass spectrometry (MS). For this reason, a desalting step (online or offline) is required for peak identification.

The use of volatile MS-compatible buffers, such as ammonium acetate, has been demonstrated to be significantly less effective in comparison with phosphate buffers when applied on classic stainless-steel instrument/column configurations due to nonspecific interactions. The latter can be counteracted by using biologically inert or biocompatible flow paths. This application note demonstrates the potential of the combination of a polyether ether ketone (PEEK)-lined Agilent AdvanceBio SEC column with the Agilent 1290 Infinity II Bio LC System for native SEC/MS analysis of mAbs.

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