Oligosaccharide Population Analysis

Oligosaccharide population analysis is used to determine the overall population profile of the N-glycans or O-glycans present in a glycoprotein. This information can be used at all stages of drug development, in conjunction with linkage analysis, to provide a detailed picture of the glycans present. It can also be used to demonstrate consistency between batches for release during the manufacturing process.

Oligosaccharide population analysis is a powerful technique in glycoprotein analysis. It can be used for:

  • Screening of glycoproteins manufactured using different cell lines.

  • Identification of unusual glycosylation profiles.

  • Confirmation of the presence of N- or O-glycosylation.

  • Identification of potentially immunogenic glycan structures.

Oligosaccharide population analysis is performed following release of the glycans from the supplied product using:

  • Matrix Assisted Laser Desorption Ionisation Mass Spectrometry (MALDI-MS) to give molecular ion data

  • Electrospray Mass Spectrometry (ES-MS) to give fragment ion information (which is useful for more detailed structural interpretation)

  • High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) to give a chromatographic profile

Oligosaccharide population 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.