Competitive advantage

The characterization of a biotherapeutic's glycan array is a regulatory requirement; however, the characterization of glycan modifications which occur during drug development and characterization is no less important and can help monitor and improve the drug manufacturing process. Significant effort is made to fully characterize glycans for deeper understanding of the product and to assess the impact of changes to product development and procedure, particularly manufacturing site and scale. As such, de novo characterization capabilities are needed. gtSuite™ with automated and semi-automated de novo glycan sequencing capabilities streamlines data interpretation allowing for greater product understanding and knowledge regarding the impact changes to the manufacturing processes have on that product.

Sequential Mass Spectrometry

Glycome Technologies Inc. utilizes ion trap sequential mass spectrometry (MSⁿ) methodology to identify and characterize glycan structures. MSⁿ analysis can be performed on most glycoconjugates, including but not limited to N-linked glycoproteins, O-linked glycoproteins, glycolipids, and glycosaminoglycans. The MSⁿ sequencing methodology resolves the major problems confronting industry glycoanalysts:

• Heterogeneity: Because individual glycoproteins and glycosylation sites carry many different oligosaccharide structures, the glycosylation of a protein is almost always heterogeneous.
• Branching: The non-linear structure of carbohydrates increases analytical difficulty.
• Isomeric oligosaccharide structures: The branched structure and identical molecular weight of many monosaccharides result in many different oligosaccharide structures with the same molecular weight, greatly complicating glycosylation analysis.

MSⁿ through sequential rounds of product ion isolation and fragmentation extracts sufficient information for the accurate de novo characterization of glycans. MSⁿ methodology can be employed independently through direct infusion of biological mixtures or coupled with upfront chromatographic modes of separation.