Non-clinical Assessments of Immunogenicity

Immunogenicity (development of anti-drug antibodies) is a significant impediment to development and licensure of any therapeutic-protein. Recent progress in the development and use of non-clinical and pre-clinical assessments of immunogenicity will be presented along with examples demonstrating good predictive outcomes. I will illustrate how judicious application of these tools can permit better decision making during drug-development, licensure, and clinical-trials.