How stability studies get your mAb candidate FDA-approved

March 23, 2022

Your monoclonal antibody (mAb) candidates need extensive stability characterization at multiple points along their journey to become commercial drugs. This ensures the quality and safety of the final drug for clinical trials and approval by the FDA. 

This infographic outlines the typical timeline from discovery to launch of a new mAb-based drug, and explains why stability studies are needed for successful development at key points of the different phases of approval. You’ll get an overview about stability study requirements, and learn how stability data supports the filing of the Investigational New Drug (IND) application – to authorize clinical investigations, as well as the Biologics License Application (BLA) – the request for FDA authorization to market your mAb therapeutic.

Learn the objectives for both IND and BLA filing processes, and the importance of stability studies throughout the different phases of approval.
 

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