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- Day 4, May 18（Fri.） Poster
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4P-34 PDF
Direct LC/MS analysis method of surfactants contained in antibody drugs with using polymer-based reversed phase column
During the production of antibody drugs, small amounts of surfactants may be added to solubilize or stabilize IgG, and thus knowing the concentration of such surfactants are also important QC factors. Quantification of surfactants can be difficult as they coexist with complex matrixes and have low UV absorption. Therefore, by using a polymer-based column, Shodex™ ODP2 HP-2D, we developed a rapid LC/MS method for quantifying polysorbate (Tween) in the presence of IgG and NaCl as matrixes, without the necessity of deproteinization nor desalting sample pretreatment. Aqueous solution including ammonia / acetonitrile was used as eluent, and ESI-MS was used for detection. Here, alkaline eluent is effective for eluting IgG at V0, which can be only done by polymer-based reverse phase columns that are durable against alkaline conditions. The method developed in this application is fast and high-sensitive for the analysis of Tween which has potentials in antibody drug QC analysis.