Title: High Throughput Methods for Biophysical Characterization of Monoclonal Antibodies
Abstract: New high throughput methods of biophysical characterization of monoclonal antibodies were developed to accelerate the process of pharmaceutical drug development. The methods, thermostability screening, detection of aggregates and viscosity measurements, can be performed in multi-well plate format, and require low amounts of protein sample. A wide range of protein concentrations including concentrations typically used in pharmaceutical formulations can be studied. Case studies are presented and the results compared between new and older techniques. We have shown that the new methods are fully comparable with previously used techniques such as differential scanning calorimetry, size exclusion chromatography and viscosity measurement by the cone and plate method. The new methods have advantages of efficiency and high throughput capability and could be widely applied in the biopharmaceutical industry for formulation and process development and characterization.