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Monoclonal antibodies (mAbs) continue to dominate biopharmaceutical approvals and constitute about 40% of biotherapeutics that are available on the market and thus form a major class of molecules produced and developed by the biopharmaceutical industry. Product quality and quantity are important measures in antibody discovery and in process development. It is crucial to get a deeper understanding of the biological system, the process, the product and the interdependencies amongst each other. The glycosylation can profoundly affect protein stability and the functions, which are relevant to their therapeutic application.
The glycan structure is affected by the enzymatic machinery of the host cell, transit time in the Golgi bodies, environmental factors and the availability within the sugar nucleotide pool. The most commonly applied technique for the complete structural elucidation of glycoprotein oligosaccharides is the application of a combination of chemical, enzymatic, and chromatographic techniques combined with mass spectrometry.