ABSTRACT
Protein formulation is emerging as a distinguishable branch of pharmaceutical sciences, with a growing and sizable body of literature (Manning et al. 1989; Arakawa et al. 1993; Cleland et al. 1993; Carpenter et al. 1997; Wang 1999, 2000). The science of protein formulation is, however, still in its infancy such that no general and easily accessible solution exists for protein stabilization. While the two major dosage forms for protein pharmaceuticals, liquid and lyophilized solid, both present unique challenges, they share a common goal: to overcome the inherent physical and chemical instability of proteins such that a stable product with sufficient shelf life for commercialization can be achieved. The major challenge in protein formulation is therefore to identify the major pathway(s) of instability of the protein by investigating the biochemical and biophysical properties of the protein that impact its stability. Once these properties are understood, the formulation effort can progress to the identification of excipients and conditions that provide optimal stability of the formulated biopharmaceutical.
