Abstract
A great number of new therapeutic protein have been widely used and investigated in recent years. While protein is generally stable in aqueous solution for short periods, pharmaceutical products are required to be stable through the storage during several months to several years. For the purpose of long-term stability, the formulations are usually produced in solid forms by freeze-drying. As protein is present in the solution at a very low concentration, protein pharmaceuticals are mostly formulated to create a cake with addition of excipients. Other chemical components are usually added for specific purposes, such as pH buffering, improvement of stability and osmolarity balancing. Although there are many reports on the stabilization of proteins by excipients, the stabilization mechanism of protein is complicated. Therefore formulation study of proteins has developed empirically by trial and error. We should try to establish formulations from theoretical consideration. The purpose of this paper is to discuss the prediction of stability of protein formulations.
