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
Developed for the analysis of monosaccharides labeled with 2-AA using UHPLC. The LudgerSep uR2 UHPLC column contains particles with an endcapped octadecylsilane coating optimized for hydrophobic chromatography.
Dimensions: 2.1mm x 50mm
Part Number: LS-UR2-2.1x50
This reverse phase column resolves glycans based on hydrophobicity.
-Analysis of DMB labeled sialic acids
-Analysis of 2-AA labeled monosaccharides
Dimensions: 4.6 x 150mm
Part Number: LS-R2-4.6x150
The glycopeptide is comprised of an A2G2S2 glycan attached to the asparagine amino acid of a peptide with the sequence Lysine-Valine-Alanine-Asparagine-Lysine-Threonine (KVANKT).
Purity: >90% as determined by UHPLC
Monoisotopic mass: 2865.1763 [M+H]+
Amount: 10 micrograms
Part number: BQ-GPEP-A2G2S2-10U