The rapid development of biosimilar drugs has brought the need of robust comprehensive structural and functional characterization to support the evaluation of similarity. Higher order structure characterization is a critical component of the comparison, where the application of a wide range of orthogonal techniques probes aspects of structure.  This includes size, stability, secondary structure, overall fold and surface information.  With an increase in size and complexity in these molecules, such endeavors are challenging and additional complementary techniques are emerging. Here we present a study where HOS of a brand and biosimilar antibody are compared, utilizing both traditional methods including circular dichroism, differential scanning calorimetry, dynamic light scattering, fluorescence spectroscopy and novel NMR methods. The different methods to assess analytical similarity between the brand and biosimilar will be presented.

Application biophysical techniques and NMR for higher order structure biosimilarity studies

251st National Meeting (2016)

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