Glycan quantification is fundamental to many subjects including critical quality attribute testing of monoclonal antibody (mAb) therapeutics in biomanufacturing (biosimilars). Currently, labs rely on qualitative or semi-quantitative techniques for determining extent of glycosylation. Reference materials are an important first step toward quantitative measurement of the glycans associated with therapeutic glycoproteins. The National Institute of Standards and Technology (NIST) is developing a suite of pure glycan materials into Standard Reference Material (SRM) 3655 Glycans in Solution for underpinning quantitative measurements of mAb glycans. A unit of SRM 3655 will consist of 12 individually ampouled and highly characterized glycan solutions, with each certified for concentration. The 12 glycoforms represent some of those most commonly found on therapeutic monoclonal antibodies, including: G0, G0F, G1a, G1b, G2, G2F, G2FS1b(6), G2FS2(3), G2FS2(6), G2S1b(6), G2S2(3), and G2S2(6). Glycans were produced through synthetic and chemoenzymatic techniques with enzymatic remodeling to create symmetric and asymmetric bi-antennary structures. SRM 3655 will be provided as aqueous solutions with glycan concentrations ~ 10 µM, and ~ 1 nmol / glycan/ ampoule. This quantitative and traceable glycan SRM is intended to promote quantification of glycosylation for stability testing and assessing biosimilarity, and to benchmark quantitative assays.

Development of a glycan reference material for therapeutic proteins

2019 Fall National Meeting

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