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:
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.
We thank these people who helped design the study:
Please contact Dr. M. Lorna De Leoz at email@example.com or (301)-975-6731.