NIST Standard Reference Material (SRM) 3655 helps biopharmaceutical manufacturers measure glycan molecules in protein drugs, including monoclonal antibodies (mAbs), which currently dominate the biopharmaceutical market. Glycan profile is considered a “critical quality attribute” because differences in glycan structure can affect mAb safety and efficacy. This is an important property used to assess the quality of biopharmaceuticals. Therefore, it is important that biopharmaceutical manufacturers and regulators have confidence in the analysis of glycans in pharmaceuticals.
SRM 3655 is the first standard for quantitative glycan characterization. It is traceable to the International System of Units (SI) and can be used as a calibrant to measure N-linked glycans on mAbs with limited analytical bias. The mass fractions of 13 of the most common and abundant glycans in mAbs were determined gravimetrically and confirmed by mass spectrometry. Glycan mass fraction and molarity values are NIST certified. This means that the researcher has the highest confidence in the accuracy of the data, in that all known or suspected sources of bias have been fully investigated or explained by his NIST.
This SRM helps the biopharmaceutical industry assess the consistency of their manufacturing processes and provides a clearer understanding of drug glycan structure and content. It can also be used by researchers studying glycomics and cancer.
The SRM 3655 unit consists of 13 aqueous solutions of glycans commonly associated with monoclonal antibody therapeutics. Each solution contains a known mass fraction of purified free reduced glycans. The SRM 3655 unit consists of thirteen 0.5 mL vials, each containing approximately 0.2 mL of solution, frozen.
Lowenthal MS, Toman B, Lang BE, Phinney KW (2021) Certification of Standard Reference Material® 3655 glycans (frozen) in solution. (National Institute of Standards and Technology, Gaithersburg, MD), NIST Special Publication (SP) 260-224. https://doi.org/10.6028/NIST.SP.260-224
https://www.nist.gov/news-events/news/2022/08/nist-issues-first-standard-reference-material-quantitative-analysis-glycans NIST Publishes First Standards for Quantitative Analysis of Glycans