Monosaccharide analysis is a requirement from ICH Q6B guidelines for lot release characterization of glycoproteins being developed as biopharmaceuticals. This assay provides evidence of the presence or absence of N and O-linked glycans, as well as the relative amounts of each monosaccharide present. When compared to prior lots, this data can provide insight into process variations and provide prof of consistency during the manufacturing process.
The method is reliable and easy to use:
- Release of monosaccharides from the glycoprotein by mild acid hydrolysis
- Fluorescent labeling of released monosaccharides with 2-AA
- Relative quantitative analysis of 2AA-labelled monosaccharides by HPLC or UHPLC