ABSTRACT
Once the selection of delivery route, excipients, and physical state is made during formulation development, studies to examine the stability of the product under recommended and stressed storage conditions must be performed to ensure product quality and safety. These studies utilize analytical methodologies to evaluate the stability of the protein. This entry will continue the discussion of the development of the formulation, with a focus on the requirements for stability testing and manufacturing to be able to successfully deliver the final formulated product to patients.
