Your 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 FDA.
This infographic outlines a typical timeline to launch a new mAb-based drug. It focuses on the role of stability studies during the filing of the Investigational New Drug (IND) application – to authorize clinical investigations, and also the Biologics License Application (BLA) – the request for FDA authorization to market a mAb therapeutic.
Learn about the definitions and objectives of both IND and BLA processes, and the importance of stability studies throughout the different phases of approval.