High-throughput formulation screening of therapeutic proteins.

High-throughput screening (HTS) is used extensively in drug discovery to identify active compounds. Automated preparation and sample analysis in multiwell plates using a combination of liquid and/or powder handling stations, robotics and sensitive detection devices provide powerful tools. At present, protein formulation remains a slow process and will benefit from a fast formulation screening approach. The use of multiwell plates enables the simultaneous screening of many excipients and experimental conditions, such as buffers, salts, surfactants, sugars, storage temperature and mechanical stress. This article reviews the application of the HTS methodology for the development of different protein formulations, such as stable liquids, lyophilisates and slow release forms.: