Analytical Considerations in Formulation: Timing, Thoroughness, Simplicity, and Extensive Product Knowledge Are Essential Components

摘要

Pormulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success. A biopharmaceutical formulation consists of active pharmaceutical ingredient and other ingredients that help maintain the drug product's chemical, biochemical, and physical attributes, particularly those related to stability, safety, efficacy, and potency.