Shodex advanced HPLC columns has produced an application note describing the analysis of aggregates and additives in antibody drugs, using different kinds of size-exclusion columns.
Antibody drugs are important therapeutic drugs that, because of their highly specific targeting capacity to the cancer cells, can cause fewer side effects. However, it is known that they may aggregate to form dimers and other larger aggregates during the manufacturing process and/or during the storage period. Monitoring of such aggregates is important for quality control (QC) purposes.
This application note demonstrates a rapid LC/MS method for quantifying polysorbate (Tween) in the presence of IgG and NaCl as matrixes, without the need of sample pre-treatment using a polymer-based reversed-phase column, Shodex™ ODP2 HP-2D.
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