Predictive Screening Tools Used in High-Concentration Protein Formulation Development.

This review examines the use of predictive screening approaches in high-concentration protein formulation development. In addition to the normal challenges associated with protein formulation development, for high-concentration formulations, solubility, viscosity, and physical protein degradation play major roles. To overcome these challenges, multiple formulation conditions need to be evaluated such that it is desirable to have predictive but also low-volume and high-throughput methods in order to identify optimal formulation conditions very early in development without time- and material-consuming setups. Many screening techniques have been reported for use in high-concentration formulation development, but not all fulfill the requirements mentioned previously. This review summarizes the advantages and disadvantages of different screening approaches currently used in formulation development and the correlation of predictive data to protein solubility, viscosity, and stability at high protein concentrations.