ABSTRACT

There are many new human therapeutics that are glycosylated recombinant proteins. These recombinant glycoproteins require ‘‘correct’’ glycosylation for clinical efficacy. For this reason, uncontrolled changes in protein glycosylation are of great regulatory and industrial concern. Protein glycosylation is strongly influenced by many environmental factors, such as dissolved oxygen (DO), pH, carbon source, and temperature. In many instances, recombinant glycoproteins are highly expressed relative to native proteins, potentially exacerbating the influence of environmental factors that alter the expression or function of the enzymes controlling glycosylation.