Glycosylation and Carbohydrate Analysis

Analysis of carbohydrate mediated heterogeneity of therapeutic glycoproteins is important in clinical evaluation since oligosaccharides may influence biological activity, pharmacokinetics and immunogenicity of these products. These raise regulatory concerns regarding their purity , consistency and safety.

 Regulatory Issues

Purity and Consistency:

Carbohydrate Compositional Data
Identification of Glycosylation Sites
Lot to Lot consistancy

Regulatory Issues

Safety:

Will Change in Glycosylation Cause
Altered Tissue Distribution Altered Pharmacokinetics
Immune Complex Formation

Our Solutions:

We can help to address such issues and help to determine monosaccharide compositions, oligosaccharide maps, sialic acids  and client defined projects involving complex carbohydrate analytics  of  therapeutic biologicals