UHP-SEC Analysis of Immunoglobulins with TSKgel UP-SW3000
Antibody therapeutics are dominating the biopharmaceutical market. In 2013, six of the top ten global drug brands were monoclonal antibodies (mAbs). The characterization of these complex biomolecules is a major challenge in process monitoring and quality control. The main product characteristics to be monitored by chromatography are aggregate and fragment content, glycosylation pattern and charged isoforms.
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The standard QC method for mAb aggregate and fragment analysis is size exclusion chromatography (SEC). A new series of 2 micron silica based UHPLC columns with 25 nm pore size can be applied to either increase speed or improve resolution of the separation of antibody fragments, monomers, and dimers.