NIST Interlaboratory Study on the Glycosylation of NISTmAb, a Monoclonal Antibody Reference Material, June 2015 to February 2016

Published: July 31, 2017

Author(s)

Maria Lorna A. De Leoz, David L. Duewer, Stephen E. Stein

Abstract

The National Institute of Standards and Technology coordinated an interlaboratory study for laboratories that measure glycosylation in monoclonal antibodies. This report describes the design of and results for the NIST Interlaboratory Study on the Glycosylation of NISTmAb, a Monoclonal Antibody Reference Material from 103 reports submitted by 76 laboratories. Two materials were used in the study, 1) the Primary Standard (PS) for NIST Reference Material 8671, NISTmAb, Humanized IgG1κ Monoclonal Antibody, and 2) a material derived from the PS by treatment with galactosidase. The study was conducted in two stages: Stage 1 involved nine selected laboratories who volunteered to assist in final study design; Stage 2 was widely advertised and open to all laboratories. The materials for the study were shipped to participants in two batches: June 2015 and August-September 2015 for Stage 1 and Stage 2, respectively. Participants were requested to provide measurement results by July 30, 2015 (Stage 1) and November 6, 2015 (Stage 2).
Citation: NIST Interagency/Internal Report (NISTIR) - 8186
Report Number:
8186
Pub Type: NIST Pubs

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Keywords

Glycan, Glycopeptide, Glycosylation, Glycoform, Glycomics, IgG, Monoclonal Antibody, NISTmAb, RM 8671
Created July 31, 2017