Comprehensive N-glycosylation Analysis During Biologics Manufacturing Focusing on Biosimilarity
Glycosylation is considered one of the most important critical product attributes (CPA) of glycoprotein biotherapeutics, and of any subsequent biosimilars. Because of this, the carbohydrate moieties of the biopharmaceuticals should be closely scrutinized during all stages of development and manufacturing, and should correlate appropriately during comparability or biosimilarity exercises. Due to the complexity of the analytical profile, and the biological processes that might be affected, it is challenging to determine and quantify the level of similarity between the N-glycosylation characteristics of two glycoproteins.
In this webinar, Dr. Andras Guttman presents the Glycosimilarity Index — a scoring approach that can be used to accurately calculate the level of similarity between the N-glycosylation profiles of any given reference material and biosimilar.
Key Learning Objectives:
- Simplified N-glycosylation sample preparation workflow and analysis
- Rapid, less than 5-minute separations of fluorophore labeled glycans
- High-resolution separations
- Automated glycan identification based on glucose unit (GU) values and if necessary, carbohydrate sequencing
- Quantitative comparison of N-glycan profiles based on relative peak areas
Who Should Attend:
- Laboratory managers and scientists at biopharmaceutical companies and contract research labs interested in N-glycan analysis
- Liquid chromatography (LC) and capillary electrophoresis (CE) users looking for increased screening capabilities