We've updated our Privacy Policy to make it clearer how we use your personal data. We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement

How Stability Studies Get Your mAb Candidate FDA-Approved

How Stability Studies Get Your mAb Candidate FDA-Approved content piece image

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).

Download this infographic to explore:

  • 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