This shows you the differences between two versions of the page.
— |
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: | ||
+ | |||
+ | |||
+ | * **Identify: | ||
+ | * **Quantify: | ||
+ | * **Report: | ||
+ | Submissions were coded to ensure confidentiality. | ||
+ | |||
+ | |||
+ | ==== ==== | ||
+ | |||
+ | ==== Rationale ==== | ||
+ | |||
+ | |||
+ | Alteration in glycosylation may significantly modify the biological activity of monoclonal antibodies. | ||
+ | |||
+ | |||
+ | 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:// | ||
+ | * 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 | ||
+ | |||
+ | |||
+ | |||
+ | |||