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.

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.

• 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.

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, Ludger Ltd, www.ludger.com
• 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