The lead molecule is characterized by all available protein analytical tools including HPLC, mass spec, isoelectric focusing, CE profiles, and glycan content. Glycans are very difficult to study because they’re small, they’re very similar to each other and they do not absorb light or fluorescence. The strategy to characterize the glycan profile of a glycoprotein such as an antibody is to digest the glycans off of the molecule, label the glycans with a dye and obtain a profile using CE of HPLC. These manually intensive steps can take days to complete making the assay a candidate for automation.
The division of specialty in a biopharma separates protein purification from the analytics groups. The sample load on a protein analytics department cannot by supported by purification because Akta-scale purification is limited. PhyTip columns provide the solution for analytics groups to process very small volumes in high throughput allowing a multitude of analytical processes.