Comprehensive N-glycosylation Analysis During Biologics Manufacturing Focusing on Biosimilarity

Register free: http://www.chromatographyonline.com/lcgc_w/biosimilarity

Event Overview:

Glycosylation is considered as one of the most important critical product attributes (CPA) of glycoprotein biotherapeutics, and for any subsequent biosimilars. Consequently, the carbohydrate moieties of such biopharmaceuticals should be closely scrutinized during all stages of development and manufacturing and correlate accordingly during comparability or biosimilarity exercises. Due to the complexity of the obtained analytical profile and biological processes they might affect, it is challenging to determine and quantify the level of similarity between two glycoprotein’s N-glycosylation characteristics.

This work represents a glycan profile similarity scoring approach, referred to as Glycosimilarity Index, that can be used to accurately calculate the level of similarity between the N-glycosylation profiles of any given reference material and biosimilar. In addition, the Glycosimilarity Index also reflects the level of similarity between the N-glycan profiles of the reference and test items in terms of their contribution to efficacy, safety and clearance.

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 GU values and if necessary, carbohydrate sequencing

• Quantitative comparison of N-glycan profiles based on relative peak areas

Speaker: András Guttman, Senior Manager, CE Applications, SCIEX CE & BioPharma

Time and Date: Wednesday, Aug. 21, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing Aug. 21, 2020

Sponsor: SCIEX

Register free: http://www.chromatographyonline.com/lcgc_w/biosimilarity