Some examples of our projects
- Assay Validation/Release Testing. One of our standard oligosaccharide profiling methods was determined to be appropriate for use in tracking the glycosylation of the client’s glycoprotein produced in CHO cells. The assay was validated at GlycoSolutions and has been used for release and stability testing of the drug (now marketed) for over three years.
- Polysaccharides. An assay was developed to measure the amount of two contaminating polysaccharides in a client’s product using monosaccharide analysis.
- Glycosidase Sequencing. The major N- and O-linked oligosaccharide structures present on a glycoprotein being used in a vaccine were isolated and identified by glycosidase sequencing.
- Comparability Studies. Using our oligosaccharide profiling method we were able to show that the glycosylation of a client’s glycoprotein was affected by a change in the manufacturing process. Oligosaccharide peaks were isolated from glycoprotein produced by the two different processes. The oligosaccharide structures were identified by mass spectrometry to gain an understanding of the change seen in glycosylation after the process change.
- Process Development. We helped a client determine the optimal cell culture conditions for preferable glycosylation using our oligosaccharide profiling and sialic acid analyis.
