chemdata:glyco_call

Ongoing: Interlaboratory Study on Glycosylation Analysis

Overview

Laboratories engaged in glycoanalysis were invited to participate in this multi-laboratory study. Two samples were distributed to the laboratories: one original and one modified NIST monoclonal antibody (mAb) Standard Reference Material. Participants used their own method to analyze the glycans and were asked to:

  • Identify: Identify the major and minor N-glycans in the two samples using their own analytical method
  • Quantify: Determine any glycan differences in the distribution of the N-glycans in the two samples
  • Report: Submit a tabulated report and if possible, raw data

Submissions were coded to ensure confidentiality. We intend to publish the results in a refereed journal.

Rationale

Alteration in glycosylation may significantly modify the biological activity of monoclonal antibodies. Thus, analysis of their glycoforms is essential, whether it is a batch-to-batch analysis of a drug candidate, comparison of the glycan profile of a biosimilar, or a complete glycomics profiling of a new drug. There are several published methods to quantify and identify glycoforms in proteins, but there are only a handful of multi-lab studies to assess the performance of these various approaches.

NIST is currently developing a well-characterized mAb Standard Reference Material and plans to use this material in this interlaboratory study. The goals are to determine measurement variability in identifying and quantifying N-glycans across laboratories and aid in the determination of the correct glycan composition of the NIST mAb.

Updated Timeline

  • NIST began distribution of samples to labs: August 31, 2015
  • Labs submit results electronically to NIST: November 6, 2015
  • Please note that report submission is now closed.

Acknowledgements

We thank these people who helped design the study:

  • Dr. Joseph Zaia, Boston University
  • Dr. Manfred Wuhrer , VU University Amsterdam
  • Dr. Carlito Lebrilla, University of California-Davis
  • Dr. Vernon Reinhold, University of New Hampshire
  • Dr. Louis Royle, Lutger Ltd.
  • Dr. Albert Heck, Utrecht University
  • Dr. CT Yuen, National Institute for Biological Standards and Control (NIBSC)
  • Dr. Pauline Rudd, National Institute for Bioprocessing Research and Training (NIBRT)
  • Dr. Ron Orlando, University of Georgia
  • Dr. Parastoo Azadi, Complex Carbohydrate Research Center
  • Dr. Yehia Mechref, Texas Tech University
  • Dr. Nancy Leymarie, Boston University
  • Dr. Paul Rudnick, Spectragen Informatics
  • Dr. Douglas Sheeley, National Institutes of Health (NIH/NIGMS)
  • Dr. John Cipollo, Food and Drug Administration (FDA)
  • Dr. David Duewer, NIST
  • Dr. Dean Ripple, NIST
  • Dr. Lai-Xi Wang, University of Maryland

For more information

Please contact Dr. M. Lorna De Leoz at lorna.deleoz@nist.gov or (301)-975-6731.

chemdata/glyco_call.txt · Last modified: 2016/08/09 14:25 (external edit)

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