ABSTRACT
Preformulation is typically the fi rst step in characterizing and developing a drug product. Very often, a protein identifi ed through genomics or proteomics may go into preclinical development prior to having a full understanding of its mechanism of action. Due to the various potential degradation pathways of proteins, understanding and overcoming their inherent physical and chemical instabilities becomes one of the major challenges faced by the formulation scientist. The various studies and drug development activities performed with the goal of overcoming the protein’s inherent instabilities constitute the formulation development process. Developing a product that is stable, safe, effi cacious, and marketable will be the focus of the formulation scientist’s efforts.
