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Measuring glycans from biopharmaceuticals using LC-Q/TOF

This project at University of Delaware will be led by Mark Blenner. This project is part of a larger small-group study to evaluate the variability associated with operator-associated variability in measuring released glycans from a monoclonal antibody.
Categories
Assays
Project status
100% Completed

Industry Need

  • Enhanced and/or standardized ability to measure and quantitatively evaluate the glycan profile of a reference monoclonal antibody 

Solution

The University of Delaware will procure an Agilent 1290ii uHPLC, 6545XT Advance Bio Q/TOF. This approach will be used to measure and quantitatively evaluate the glycan profile of a reference monoclonal antibody using glycan standards as well as the glycan profile of a reference monoclonal antibody where the release was performed at a central laboratory.  


After this project is completed, the uHPLC-Q/TOF will be available on a priority basis for NIIMBL-related technology and workforce activities, within any necessary constraints of the host institution, to be negotiated with NIIMBL. 

Outcomes and Impacts

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

Updates, Related Publications, and Deliverables

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Project Lead

University of Delaware

University of Delaware