A collaboration between Waters and Ireland's NIBRT is hoped to make fast and accurate glycosylation analysis a reality for the makers of biotherapeutics.
Waters and the National Institute for Bioprocessing Research and Training (NIBRT) will create the world's first database for glycan analysis by UltraPerformance Liquid Chromatography (UPLC).
Expected to be available in 2011, the National Institute for Bioprocessing Research and Training (NIBRT) will develop, maintain and licence the database and co-market it with Waters.
The database, to be developed by Prof Pauline Rudd's group in NIBRT, will be a repository of chromatographic retention times for sets of glycan structures associated with a range of biotherapeutics.
The aim is 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 potentially gain a greater degree of control over their manufacturing process in line with regulatory guidelines aimed at guaranteeing safe and efficacious biotherapeutics.
Jeff Mazzeo, director, Biopharmaceutical Business Operations, Waters, said: 'Our goal is to simplify and introduce more certainty into the process of analysing glycans and making quality biomolecules.
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.
When available, the combination of NIBRT's database, together with the Waters UPLC Glycan Solution, will readily assign glycan structures - complex, neutral, high-mannose and sialylated - to each UPLC peak for confirming known structures present in a sample or to look at Gu values and identify unknown or unexpected glycans.
In an application note discussing its UPLC Glycan Analysis Solution, Waters describes its methodology for glycan analysis by UPLC in greater detail.
