Protein and Peptide Formulation Development

Proteins/peptides are generally much more sensitive to process- or storage-induced degradations than small synthetic molecules. Therefore, significant efforts are needed to formulate these protein/peptide drug candidates into viable commercial products.This chapter reviews the degradation processes in proteins/peptides, describes factors affecting protein/peptide stability, and discusses strategies in the successful development and manufacturing of protein/peptide commercial products. Keywords: protein formulation development; fill-finish processes; protein instability; aggregation; macromoelcular crowding; tangential flow filtration (TFF); lyophilization