Integrated Analytical Characterization of Highly Heterogeneous Drugs

The active ingredient of protein-based biopharmaceutical drugs such as monoclonal antibodies, are heterogeneous due to modifications to the protein backbone sequence and post-translational modifications (the most complex being glycosylation) that arise from their biosynthesis and manufacturing processes. We have been developing an integrated approach is to assemble the analytical tools in a layered fashion that reflects the heterogeneity of the biopharmaceutical drug. As an example, in the case of monoclonal antibodies, an example of the layers is – i) intact antibody, ii) peptide/glycopeptide and iii) glycosylation. It is evident from the aforementioned layered analysis that multiple attributes overlap between the layers providing a means to cross-validate these attributes for a robust characterization of the complex drug to understand key relationships between the critical process parameters and product quality attributes.​

For Research Use Only. Not for use in diagnostic procedures.