Orthogonal tools for analytical biosimilarity assessment of biotherapeutics

Figure 1. Graphic representation of analytical comparability assessment workflow for biosimilar products. For attributes relating to Higher Order Structure such as size (size impurities can vary significantly in size) and melting temperature, orthogonal tools are often used. Our studies show the utilization of NMR as an orthogonal tool to DLS and NanoDSF as an orthogonal tool to CD for size and transition temperature estimation of monoclonal antibody based biologics, respectively.

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