Integrated glycan analysis of monoclonal antibodies using UPLC-MS

This project at MassBiologics of University of Massachusetts Medical School will be led by Dr. David McNally and Dr. Tianyuan Peng. This project is part of a larger small group study to evaluate the variability associated with operator-associated variabil
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 Massachusetts will procure a Waters BioAccord LC-MS system. 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.

Impacts

Upon project completion, the Waters BioAccord LC-MS system 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.

Evaluate 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

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

Outputs/Deliverables

  • Instrument procurement, installation and ready for functional use
  • Execute MTA and receive samples from NIST
  • Glycan analysis method development and sample testing
  • Data summarization and reporting

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Project Lead

University of Massachusetts System

University of Massachusetts System