Background
This advanced two-day training course in immunogenicity testing is designed to meet the increased demand for training that goes beyond the basics. This interest has been kindled by the increased complexity associated with the elucidation of the immune response and the effect of antidrug antibodies (ADA) upon safety and efficacy. This new course includes training in more advanced methods and approaches for characterizing ADA, prediction and prevention of immunogenicity, new technologies, and additional statistical models for immunogenicity assessment.
Goals and Objectives
Following its introduction in 2009, the two-day training course Development of Ligand Binding Analytical Methods to Support Immunogenicity Testing: Theoretical to Practical Considerations has been offered each year (2009, 2010, 2011) at the AAPS National Biotech Conference. Recently, there has been a great amount of interest in offering an advanced course that goes beyond the basics to address a broader range topics of interest in greater depth. This interest has been kindled by the greater number of companies entering the biotech arena, increased complexity associated with the elucidation of the immune response and the effect of anti-drug antibodies upon safety and efficacy. The goal of this new course will be to provide in-depth training in the more advanced methods and approaches for detection, characterization, and titer assessment of antidrug antibodies, prediction and prevention of immunogenicity, new technologies, additional statistical models for immunogenicity assessment, and detection and characterization of immune complexes.