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:
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Screening of glycoproteins manufactured using different cell lines.
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Identification of unusual glycosylation profiles.
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Confirmation of the presence of N- or O-glycosylation.
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Identification of potentially immunogenic glycan structures.
Oligosaccharide population analysis is performed following release of the glycans from the supplied product using:
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Matrix Assisted Laser Desorption Ionization Mass Spectrometry (MALDI-MS) to give molecular ion data
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Electrospray Mass Spectrometry (ES-MS) to give fragment ion information (which is useful for more detailed structural interpretation)
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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 characterization and confirmation of biopharmaceuticals in support of new marketing applications.
