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===== 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.


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==== 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.


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==== 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.


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==== 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, Ludger Ltd, [[https://www.ludger.com|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