User Tools

Site Tools

Trace:
chemdata:glyco_call

Differences

This shows you the differences between two versions of the page.

Link to this comparison view

chemdata:glyco_call [2019/05/06 13:57]
 chemdata:glyco_call [2019/05/06 13:57] (current)
Line 1: Line 1:
 +~~NOTOC~~
 +
 +
 +===== 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, 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
 +
 +
 +
 +
  

Page Tools