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
Equipment and Supplies
Data
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. 

Outputs/Deliverables

  • Demonstrate that Agilent’s AdvanceBio Gly-X N-Glycan Prep with InstantPC Kit is suitable for glycan release/labeling
  • Verify analytical methods using Agilent’s 6545XT Advance Bio Q/TOF for the detection and relative quantification of glycans in the SRM 3655 unknown glycan mixtures
  • Accurately and precisely measure relative glycan abundances from the NISTmAb RM 8671
  • Develop quantification methods for measure absolute G0F content for the NISTmAb 8671 using the SRM 3655 G0F standard for reference


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

Additional Project Information (Members Only)

Login to the NIIMBL member portal to access more, including: 

  • Updates
  • Value Proposition
  • Related Publications
  • Deliverables

Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.

Project Lead

University of Delaware

University of Delaware