ABSTRACT
The purpose of this chapter is to provide practical guidance to formulation scientists charged with the development of stable, manufacturable, and elegant sterile solution dosage forms of peptides and proteins (henceforth referred to as biopharmaceuticals). Ready-to-use solution dosage forms comprise the largest percentage of sterile dosage forms in the marketplace. The solution formulation must be resistant to both physical and chemical degradation and maintain all microbiological quality attributes (sterility and freedom from pyrogenic and particulate matter contamination) throughout the shelf-life of the product.
