Agilent Glycan Analysis Columns
Post-translational modifications to the primary amino acid sequence, including glycosylation, have functional consequences and can impact efficacy and immunogenicity of a biopharmaceutical. The structure of the glycan also contributes to the half-life of the protein in plasma and the ability of the monoclonal antibody to trigger the immune response required for efficacy. Regulatory authorities consider glycosylation to be one of the critical quality attributes and, therefore, it must be characterized and quantified, with acceptable ranges determined, as part of the development process for a glycoprotein innovator, biosimilar or biobetter pharmaceutical.
