Challenges in the Characterisation of Therapeutic Protein Formulations

S. Ball, M. Pothecary, P. Clarke, C. Murphy
Malvern Instruments, UK

Keywords: protein, formulation stability, dynamic light scattering, electrophoretic light scattering, protein mobility, diffusion barrier method, biotherapeutic formulations, microrheology


In recent years, the stability of proteins in solution has attracted significant scientific and commercial interest due to the exponential growth in the use of proteins as biotherapeutic drugs. Since knowledge of formulation stability and behaviour are paramount for delivery of a safe and commercially viable product, the demand for tools that can characterize these formulation properties has increased. This talk will discuss several approaches to assessing the behaviour of a drug in a chosen formulation, including Dynamic Light Scattering (DLS) and Electrophoretic Light Scattering (ELS), Microrheology and UV area imaging. In addition, a new DLS/ELS measurement technique, the Diffusion Barrier Method, will be described that improves the reliability of protein mobility measurements. This technique increases the reliability of the data generated from the measurement by isolating the protein from the cell electrodes, and preventing aggregation which could result in an inaccurate measurement.