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).
NIST Interagency/Internal Report (NISTIR) - 8186
Glycan, Glycopeptide, Glycosylation, Glycoform, Glycomics, IgG, Monoclonal Antibody, NISTmAb, RM 8671