Monosaccharide analysis is used for characterization of carbohydrates and glycans bound to glycoproteins.
Monosaccharide analysis is used to identify and quantify the different monosaccharide residues of N-link and O-link glycans bound to a glycoprotein.
In addition, it can be applied to quantify the number of glycans bound to a glycoprotein, and for detection of carbohydrate impurities in the purified biopharmaceutical sample.
Monosaccharide analysis is applicable to all stages of biopharmaceutical development and manufacturing processes including cell line and clone selection, upstream and downstream process development, manufacturing in-process control, batch consistency and release.
Monosaccharide analysis is required by ICH Q6B guidelines for biopharmaceutical characterization.
Monosaccharide analysis is performed by the separation of the monosacharides by reverse phase chromatography (RP-HPLC). The monosaccharaides are cleaved under acidic conditions from the glycoprotein, labeled with 2-Aminobenzoic acid (2AA), and separated by a RP-HPLC column. The different monosaccharaides are identified and quantified using defined standards.
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