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

Industry Need

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

Approach

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. 

Impacts

Evaluate modes of implementation of a new quantitative glycan standard, SRM 3655

Evaluate whether “community performance metrics” can be defined for NISTmAb released and/or released/labeled methods

Understand if SRM 3655 can assist in harmonizing or standardizing glycan measurements

Determine if SRM 3655 can assist in harmonizing or standardizing glycan measurements

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

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Project Lead

University of Delaware

University of Delaware