As the drug lead progresses through the developmental phases of becoming a drug, every characteristic of that lead is determined. The lead molecule is characterized by all available protein analytical tools including HPLC, mass spec, isoelectric focusing, CE profiles, and glycan content. These data are generated so that the molecule can be taken through the clinical trials and manufacturing phases to ensure that the molecule has not changed and been consistent. Biologics are synthesized, instead biologics are produced by the use of mammalian cells. So what the cells produced are intensely scrutinized to ensure consistency.
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.