Monosaccharide Composition Analysis

Monosaccharide composition analysis is used in the analysis of glycoproteins and carbohydrates to determine the identities and quantities of the various monosaccharides present. This information can be used at all stages of drug development as a method of determining the type of glycosylation (N-linked and/or O-linked) and the extent to which glycosylation has occurred. It can also be used to demonstrate consistency between batches for release during the manufacturing process.

Monosaccharide composition analysis is a powerful technique in glycoprotein analysis. It can also be used for:

  • Determination of the presence of carbohydrate impurities e.g. glucose contamination of a sample from purification column matrices or dialysis systems.
  • An initial investigation prior to more detailed analysis of the glycosylation.
  • Screening of glycoproteins manufactured using different cell lines.

Monosaccharide composition analysis is most commonly performed using chromatographic techniques such as Gas Chromatography-Mass Spectrometry (GC-MS) and High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD).

Monosaccharide composition analysis is a key part of the requirements laid out in the ICH Q6B guidelines for characterisation and confirmation of biopharmaceuticals in support of new marketing applications.