Formulation of Biologics Including Biopharmaceutical Considerations

This chapter describes the various issues a formulator of biologics faces when turning an active pharmaceutical ingredient (API) into a biopharmaceutical product that can be administered to a patient. A well-equipped analytical lab to characterize chemical and physical characteristics of the biologic in the formulation process is a first requirement. Then, the proper formulation pH, excipients, if required a drug delivery system and conditions (e.g., freeze-dried or not; refrigerated or not) to achieve an acceptable shelf life for the formulated biologic can be selected. Throughout this process one should consider the specific requirements linked to the desired route of administration, e.g., dose, volume, primary container. Alternative routes of administration are briefly discussed and their limitations listed.