Bringing More Accuracy and Efficiency to Protein Glycosylation Assessment and Greater Predictability to Biopharmaceutical Processing
The GlycoBase 3+ Database is intended to give biopharmaceutical manufacturers a timely and powerful tool for confirming the structure of various glycosylated proteins. Armed with more rapid and accurate information about glycosylation during the various stages of the manufacturing process, biopharmaceutical manufacturers can gain a greater degree of control over their manufacturing process in line with regulatory guidelines aimed at guaranteeing safe and efficacious biotherapeutics.
Recent advances in chromatographic approaches are leading to better resolution, sensitivity, and speed during the qualitative and quantitative analysis of protein glycosylation. As a proven approach for analyzing biomolecules and the glycan structures attached to them, UPLC is a potent tool for determining the relative proportions of each glycan structure in a pool.
The Waters® UPLC Glycan Analysis Solution features an ACQUITY UPLC® BEH Glycan Separation Technology column and an ACQUITY UPLC System with fluorescence detection (FLR) to separate the released glycans of biopharmaceuticals as their 2-aminobenzamide (2-AB) derivatives. The UPLC Glycan Separation Solution provides robust, high-resolving, reproducible, and rapid methods that outperform analyses by HPLC.
The combination of NIBRT's database together with the Waters UPLC Glycan Solution can readily assign potential glycan structures - complex, neutral, high-mannose, and sialylated - to each UPLC peak by matching to a dextran hydrolysate ladder (GU values). Exo-glycosidase array digestion products can also be assigned using the same bioinformatics platform, allowing the monosaccharide sequences and linkages of the oligosaccharides to be confirmed. The technology can be tailor-made to confirm structures present in samples analyzed routinely or to identify unknown or unexpected glycans.
In an application note, Waters describes its methodology for glycan analysis by UPLC in greater detail.
For more information: www.waters.com/glycans
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