A glycan-based Standard Reference Material (SRM 3655) is being developed to support the biomanufacturing and protein therapeutics communities. The SRM will consist of a set of 13 individually-bottled, pure glycoforms including those most commonly observed as N-linked glycans on therapeutic monoclonal antibodies. This quantitative glycan material will enable accurate, SI-traceable quantification of antibody glycosylation, and can be used to assess quantity, identity, or stability between labs, between production lots, or over time.
The NIST Mass Spectral Reference Libraries are continuously increasing the number of glycan and oligosaccharide reference spectra included. Recent additions include glycan from NISTmAb, NIST Human Milk SRM 1953 and oligosaccharides from a variety of mammals, including samples shared with NIST from the National Zoo in Washington, DC.
NIST Mass Spectrometry Data Center products relevant to glycomics include:
NIST coordinated an interlaboratory study for laboratories that measure glycosylation in monoclonal antibodies. A published 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.
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.