MS/MS data can also be obtained of individual glycans for antennal fragments. These data sets can be used to provide a relative quantitation of the N-linked oligosaccharides observed and suggest the structures of the N-linked glycans present.
To provide a further layer of structural detail, BioPharmaSpec can also employ chemical derivatization procedures in conjunction with GC-MS analysis to determine the nature of the linkages present between monosaccharides in the population of glycans. This is very important since certain monosaccharides, such as sialic acid, can be linked in different ways in glycoproteins and this can have an effect on function. Furthermore, for the production of Biosimilars, the Biosimilar must structurally match the Innovator drug.
The ICH Q6B guidelines require full characterization of the glycosylation of a glycoprotein. BioPharmaSpec can generate all of the information required for this full structural characterization. This applies to both the total glycan population but also the structures of the glycans at individual glycosylation sites if more than one is present.