Formulation development for hydrophobic therapeutic proteins.

The major challenges in formulation development for hydrophobic proteins are low solubility often combined with a strong tendency for adsorption. Human serum albumin (HSA) is frequently used as excipient to overcome these problems. Due to several drawbacks with HSA, new ways need to be found to circumvent the use of this excipient in protein formulations. One possible approach is to select an appropriate formulation pH and ionic strength in combination with excipients that provide sufficient stability and solubility for the hydrophobic protein. A reduction in adsorption can be achieved by adding surfactants or using special containers.