Biopharmaceutical manufacturers require reliable glycan analysis to ensure monoclonal antibody (mAb) quality, as glycosylation impacts efficacy, safety, and regulatory compliance. Many academic labs lack advanced LC-MS infrastructure, limiting participation in collaborative studies and slowing method standardization. Industry needs broader analytical capacity and validated workflows to support reproducible glycan profiling and inter-lab harmonization.
The Blenner Lab focused on infrastructure development and method validation for glycan analysis:
Assess whether “community performance metrics” can be defined for NISTmAb released and/or released/labeled methods
Evaluate modes of implementation of a new quantitative glycan standard, SRM 3655
Determine if SRM 3655 can assist in harmonizing or standardizing glycan measurements
Commissioning of the Agilent 6545XT LC/Q-TOF system allowed successful identification of major glycans on NISTmAb and quantitation of G0F using SRM 3655 standards. This capability supports the goal of reducing glycan analysis variability and provides infrastructure for future collaborative studies, potentially lowering analytical turnaround time and improving method comparability.
Acquired and installed Agilent 6545XT AdvanceBio LC/Q-TOF system.
Developed and validated glycan release and labeling protocols using InstantPC kit.
Completed glycan identification and quantitation for NISTmAb and SRM standards.
Built institutional capacity for NIIMBL projects and trained graduate student in LC-MS glycan workflows.
Delivered recommendations for future method optimization and inter-lab harmonization.
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University of Delaware
