Characterizing and monitoring the glycan population of a biotherapeutic protein has continued to present technical and logistical challenges to the biopharmaceutical industry.
Waters continuously drives technology advancements that are designed to improve released glycan analysis. Today our combined sample preparation and analytical technologies provide biopharmaceutical analysts with smart workflows for glycan monitoring and characterization.
Waters' workflow for released N-glycan sample preparation and analysis is built around the capabilities of the GlycoWorks RapiFluor-MS Kit. Our protocol significantly simplifies sample preparation, allowing deglycosylation, labeling, and sample clean-up to be completed within 30 minutes.
Glycan monitoring
The novel RapiFluor-MS reagent also improves both fluorescent and MS detection while dramatically improving MS sensitivity. Now, thanks to the reagent, which imparts a higher charge state to glycan molecules, the compact and user-friendly ACQUITY QDa Detector can be used for mass detection for an orthogonal technique to fluorescence detection in glycan monitoring.
To help with data analysis, GlycoBase 3+ database, a first-of-its-kind library developed in collaboration with NIBRT of dextran calibrated chromatographic retention values, expressed in glucose units, for a diverse array of glycan structures associated with biotherapeutics and other glycoproteins of biological interest is available with the addition of the RapiFluor-MS Glycan GU Scientific Library.
Glycan characterization
In glycan characterization, UPLC-QTof MS takes advantage of additional MS sensitivity gains for the accurate mass confirmation of low-level peaks, and enhanced MS/MS glycan fragmentation for definitive evidence of correct glycan assignment. This can be performed using the Waters Glycan Application Solution with UNIFI, which includes the Glucose Unit (GU) Glycan Library to facilitate GU and GU+ accurate mass glycan assignments.
Comparison of Released N-Glycans between Innovator and Biosimilar
About Prof. Pauline Rudd of NIBRT, a Waters Center of Innovation
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Introducing GlycoWorks RapiFluor-MS N-Glycan Kit