New RapiFluor-MS Labeling Reagent and Sample Preparation Protocol Greatly Enhances Speed, Sensitivity, Simplicity of Released N-Glycan Profiling and Characterization
New RapiFluor-MS Labeling Reagent and Sample Preparation Protocol Greatly Enhances Speed, Sensitivity, Simplicity of Released N-Glycan Profiling and Characterization (Photo: Business Wire)
This new set of technologies enables fast de-glycosylation and labeling, and a workflow that reduces sample preparation time from a day to less than one hour; allows mass detection for characterization and development 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.
“Today’s introduction is a ground-breaking approach to glycan analyses.
It means scientists can monitor and characterize released N-glycans like
never before,” said
Most biotherapeutic proteins are glycoproteins and the heterogeneous glycan populations on these proteins are critical quality attributes that affect potency, stability, and therapeutic safety profiles. New drug submissions to regulatory agencies must contain detailed structural information pertaining to the attached glycans and proof the glycoprotein can be manufactured with a consistent glycan profile.
Supporting Glycoprotein Process Development, Monitoring and Batch Release
For scientists doing biotherapeutic process development, process monitoring or batch release, pairing the new RapiFluor-MS labeling technology with Waters ACQUITY UPLC H-Class System and QDa Detector ushers in a new era for released N-glycan profile monitoring. The speed and sensitivity advantages of the reagent and protocol enable simple, routine MS analysis. Confirming glycan assignment via mass data produced by the ACQUITY QDa Detector provides information previously unavailable. Scientists are now empowered to answer questions that frequently arise during glycan profile method development, transfer, and execution without relying on mass spectrometry experts and higher-resolution LC-MS instruments. This workflow allows biopharmaceutical organizations to more readily diagnose problems, accelerate decision-making, and advance molecules to the clinic faster.
For analysts using fluorescence detection, the new kit, when used with the ACQUITY UPLC and the ACQUITY UPLC FLR Detector, reduces sample preparation time from a day to less than one hour while enhancing fluorescent sensitivity.
Supporting Glycan Characterization
Glycan characterization involves the identification of all of the glycans attached to a glycoprotein no matter how small their concentration and verification of their molecular structure. To do this efficiently requires UPLC-MS-MS instrumentation equal to the challenge.
The Waters Glycan Application Solution with
Now, with the enhanced sensitivity made possible by the RapiFluor-MS label, researchers will see a greater optical and mass spectrometric response. This facilitates accurate mass confirmation for low-level peaks and enhances MS/MS glycan fragmentation for definitive glycan assignment.
Also being launched are the RapiFluor-MS Dextran Calibration
Ladder and Glycan Performance Test Standard, based on pooled IgG, to
support benchmarking system performance and conduct Glucose Unit
(GU)-based released glycan analysis studies. Waters became the first
company to commercialize the GU-based methodology for dextran
ladder-based retention time normalization, an approach pioneered by Professor
For More Information
For more information about the GlycoWorks RapiFluor-MS N-Glycan Kit, visit www.waters.com/glycans.
For more than 50 years,
Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.
With revenue of
Waters, GlycoWorks, RapiFluor-MS, ACQUITY, ACQUITY UPLC,
Brian J. Murphy