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The majority of biotherapeutics are glycoproteins. Careful analysis is required to ensure the quality of glycoproteins used as biotherapeutics. Increasing interest in the development of biosimilar medicines has led to an ever-greater demand for highly specialized analytical methods.
Production of glycoproteins involves glycosylation steps to bind different monosaccharides and glycans to the protein. The glycosylation profile of glycoproteins affects bioactivity, immunogenicity, stability and safety of the final therapeutic products; it is also essential to demonstrating biosimilarity of glycoprotein therapeutics.
High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) is the method of choice for quantitative analysis of individual monosaccharides in glycoproteins, for glycan as well as sialic acid content analysis and identity analysis of monosaccharide composition. HPAEC-PAD requires simple sample preparation consisting of acid hydrolysis, a freeze-drying step to remove the acid, and a reconstitution step with deionized water. It is a direct analysis because neither labelling nor derivatization is required.
HPAEC-PAD has been developed to enable separation and detection of carbohydrates such as mono-, di-, oligo- and polysaccharides. The weak acidic nature of carbohydrate molecules allows highly selective separation of such compounds in a strong anion exchange stationary phase at high pH (12 - 14), enabling direct detection and quantification. Since carbohydrates are electro-active species consisting of functional groups that can be easily oxidized at a certain voltage, they can be detected directly with PAD.
With the addition of new HPAEC-PAD systems to complement our existing capacity, Solvias now offers enhanced instrumental capability along with our proven scientific experience in this increasingly important analytical area.