Regulating Monoclonal Antibody Glycosylation

Over the past decade, notable advances in the characterization and control of post translational modifications (PTMs) to enhance therapeutic properties have continued to drive the development of many next-generation biopharmaceuticals. The current status of the biopharmaceutical industry is that titer is important, but not the greatest challenge anymore. Monoclonal antibody productivity levels have reached high multi gram levels of production that are straining cells post translational modification process. Meeting specific product quality attributes is of high importance for the Biosimilar market. The demand for media and feed formulations to meet original critical quality attributes has become of high importance, for example manipulation of higher order protein glycosylation.