Monoclonal antibody candidates need extensive stability characterization along their journey to become commercial drugs. This is done to ensure the quality and safety of the final drug for both clinical trials and marketing approval by the Food and Drug Administration (FDA).
- The typical timeline and steps for the approval of a monoclonal antibody as a drug
- The definitions and objectives of both Investigational New Drug (IND) and Biologics License Application (BLA) processes
- The importance of stability studies throughout the different phases of approval