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
The LudgerTag Monosaccharide Analysis Kit contains reagents for the release and fluorescent labeling of monosaccharides found on glycoprotein biopharmaceuticals and standards.
Part Number: LT-MONO-96
The LudgerSep uR2 2.1x50mm UHPLC column has been developed for the UHPLC analysis of monosaccharides labeled with 2-AA using the LudgerTag Monosaccharide Analysis Kit.
Dimensions: 2.1mm x 50mm
Part Number: LS-UR2-2.1x50
The LudgerSep R2 4.6x150mm column has been developed for HPLC analysis of 2-AA labeled monosaccharides labeled with 2-AA using the LudgerTag Monosaccharide Analysis Kit.
Dimensions: 4.6 x 150mm
Part Number: LS-R2-4.6x150
A quantitative mix of six monosaccharides:
glucosamine - galactosamine - galactose - mannose - glucose/dextrose - fucose
10 nmols of each monosaccharide per vial
10 nmol each of 6 monosaccharide standards
CM-MONOMIX-10 - 1 vial
CM-MONOMIX-10X3 - 3 vials
This quantitative glycopeptide standard was developed for use during the sialic acid or monosaccharide release and labeling process. This will enable you to check the efficiency of glycan release, labeling, and recovery.
Purity: >90% as determined by UHPLC
Monoisotopic mass: 2865.1763 [M+H]+
Amount: 10 micrograms
Part number: BQ-GPEP-A2G2S2-10U
Xylose can be used as an internal standard when performing monosaccharide analysis. It is a monosaccharide not typically found in mammalian or yeast expression vectors.
Monosaccharide Analysis Guide
Part Number: CM-XYL-100