Abstract
The development of a biopharmaceutical into a commercial drug product proceeds through an extensive process of testing and characterization that goes well beyond what is carried out in the clinic. Coupled to this process is the supporting biophysical, biochemical, and biological work that establishes not only the ability of the drug manufacturer to make the drug consistently, but more importantly establishes the totality of the knowledge base of the drug. Along with the clinical data, drug product characterization is performed to convince regulatory agencies that the manufacturer understands the many facets of the drug and is capable of controlling its production to implement changes to improve its production and to deal with potential problems. The role of biophysical characterization in this overall process will be the focus of this chapter.
