Understanding the colloidal stability of protein therapeutics using dynamic light scattering

The combination of dynamic light scattering (DLS) with Raman spectroscopy provides the ability to extract a wealth of chemical, structural, and physical information about biotherapeutic proteins under formulation conditions.

Dynamic light scattering (DLS) using noninvasive backscatter (NIBS) detection technology is capable of measuring the hydrodynamic radius of proteins over a large concentration range (0.1 mg/mL to 100 mg/mL). As a result, it is possible to determine, in actual biopharmaceutical formulations, the bulk viscosity/restricted diffusion interaction parameter (kD), particle interaction parameter (B22), melting temperature, onset temperature of protein aggregation and transition enthalpies to assess colloidal stability.

The unique coupling of DLS with Raman spectroscopy provides the ability to simultaneously correlate colloidal parameters to protein structure under a variety of stress conditions, e.g., thermal, formulation, chemical degradation, extrinsic particulates, to enhance our understanding of protein therapeutic formulations.