Biophysical Characterisation

Biophysical Characterisation designates the application of physical measurement techniques including spectroscopy, scattering, calorimetry, and mass spectrometry to characterise the structural, thermodynamic, and dynamic properties of pharmaceutical molecules without requiring biological assay systems, providing orthogonal information complementing functional measurements.

The biopharmaceutical industry employs extensive biophysical characterisation throughout biologic development providing structural fingerprints, stability assessments, and higher-order structure confirmation. Dynamic light scattering measures hydrodynamic radius and size distribution. Differential scanning calorimetry determines thermal unfolding temperatures reflecting conformational stability. Circular dichroism probes secondary and tertiary structure. Hydrogen-deuterium exchange mass spectrometry reveals conformational dynamics and epitope mapping. Intrinsic fluorescence monitors aromatic residue environments. Native mass spectrometry characterises intact protein complexes and glycoforms. Regulatory submissions for biologic marketing applications include comprehensive biophysical characterisation packages. As analytical capabilities advance and regulatory expectations for structural understanding increase, biophysical characterisation continues expanding through novel techniques providing unprecedented molecular insight.