Waters Corporation (WAT:NYSE) and Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) announced today a collaboration that will create the world’s first database for glycan analysis by UltraPerformance Liquid Chromatography® (UPLC®). Expected to be available in 2011, NIBRT will develop, maintain and license the database while Waters and NIBRT will co-market it worldwide.
Manufacturing biomolecules can be notoriously difficult. Correct glycosylation is essential if a protein is to achieve and maintain its correct structure and therapeutic efficacy. Protein glycosylation is strongly influenced by many environmental factors during cell culture, such as dissolved oxygen, pH, carbon source, and temperature. Any change in any of these conditions at any point in the process can put product integrity at risk. So consistent glycosylation is a sensitive marker of a well-controlled process.
Given the number of possible glycan structures that can attach to a protein, it can be extremely difficult and time-consuming for life science laboratories to identify and quantify them all.
The new database, to be developed by Professor Pauline Rudd’s group in NIBRT, will be a first-of-its-kind 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.
“By combining our know-how in separations and glycan analysis with NIBRT’s expertise in glycobiology we can make fast and accurate glycosylation analysis a reality for the makers of biotherapeutics,” said Dr. Jeff Mazzeo, Director, Biopharmaceutical Business Operations, Waters Division. “Our goal is to simplify and introduce more certainty into the process of analyzing glycans and making quality biomolecules.”
“NIBRT’s expertise in glycobiology together with Water’s expertise in separation science will ensure that this collaboration will develop and deliver rapid and robust technologies for the assessment of glycoproteins, while meeting the requirements and guidelines of the regulatory agencies,” said Dr. Maurice Treacy, NIBRT CEO.
Many protein-based biopharmaceuticals are glycosylated proteins. Glycosylation is a form of co-translational and post-translational modification that links glycans to proteins, lipids, and other organic molecules. The glycans directly affect the efficacy and safety of glycoprotein biopharmaceuticals.
Recent advances in chromatographic approaches are leading to better resolution, sensitivity, and speed for greater reliability during the qualitative and quantitative analysis of protein glycosylation. UPLC is a proven approach for analyzing biomolecules and the glycan structures attached to them and for determining the relative proportions of each glycan structure.
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.