Quantitative N-Glycan Mapping of Glycoprotein Therapeutics by HPAEC-PAD: Glycosylation Characteristics of Different Recombinant Human EPO Products

The consistent and appropriate control of the quality of N-linked oligosaccharides of recombinant glycoproteins during fermentation is a major issue in successful commercial protein manufacture, and regulatory authorities (FDA, EMEA) put high requirements on the quality and reproducibility of biopharmaceutical products. The glycosylation pattern of a therapeutic glycoprotein is influenced by cell type and cell culture environment (e.g. age of batch, glucose limitation, oxygen starvation, intracellular ammonium ion accumulation, pH changes). Glycosylation is the most complex post-translational modification made by animal cells, which makes a vital contribution to the biological activity and therapeutic efficacy of pharmaceutical glycoproteins (Grabenhorst and Conradt, 1999; Nimtz et al., 1993).