Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding agency expectations should allow a reasoned and risk-based approach to assessing potential problems with immunogenicity. This webinar will provide a general overview of immunogenicity while also addressing specific topics on development and validation. Included in the discussion are understanding and establishing the initial screening method and method to assess neutralizing antibodies.