Waters GlycoWorks RapiFluor-MS Kit Saves Biopharmaceutical Industry Nearly Four Years of Work

Waters Corporation (NYSE:WAT) has announced that, since its introduction a year ago, the GlycoWorks™ RapiFluor-MS™ N-Glycan Kit has already saved biopharmaceutical laboratories approximately 3.9 years of work in just its first year of availability. These calculations are based on purchases by all 15 top revenue generating pharmaceutical companies and 90% of the top biopharmaceutical companies with glycoproteins in their pipeline. 

Most biotherapeutic proteins available on the market today are glycoproteins. The heterogeneous glycan populations on these proteins are critical quality attributes that affect potency, stability, and therapeutic safety profiles. As a result, biopharmaceutical companies must provide detailed structural information pertaining to the glycans attached to their biotherapeutics when submitting new applications to regulatory authorities and on an ongoing basis throughout the manufacturing process. Waters estimates about 4.4 million released glycan analyses are performed per year, and that number is growing at double digit rates. A ground-breaking technology for characterizing glycoproteins, the GlycoWorks RapiFluor-MS N-Glycan Kit combined with Waters® ACQUITY UPLC®, the ACQUITY® UPLC FLR Detector and the ACQUITY QDa® detector, enables scientists to analyze released N-glycans and achieve new levels of speed, sensitivity and simplicity while obtaining previously unattainable structural information. 

This new set of technologies enables fast de-glycosylation and labeling, thereby reducing sample preparation time from a day to less than one hour. It also allows mass detection for characterization with sensitivity that is 100 to 1,000-fold better than current approaches, and enables routine laboratory use supported by a simple robust protocol without involving MS experts. Depending on a laboratory’s sample preparation needs, the GlycoWorks RapiFluor-MS N-Glycan Kit is available in either a 24-sample or 96-sample format. 

With the RapiFluor-MS N-Glycan Kit, laboratories are developing one-hour deglycosylation and labeling methods that once took 24 hours or more. This video describes how one of those laboratories completely transformed their monoclonal antibody glycoprofiling methodology.