Goals and Objectives

The focus of this course is on the development and validation of analytical methods required for the detection and characterization of the anti-drug antibodies present in pre-clinical and clinical samples. The participants should gain familiarity with:

• the basic principles of the immune response as it is involved in the development of antibodies to biotherapeutic agents;
• the analytical methods used in the detection, measurement and characterization of the anti drug antibody response;
• regulatory perspective on immunogenicity of biotherapeutics and regulatory expectations for pre and post licensing; and
• challenges in the development and validation of analytical methods for quantitative vs. detection, approaches and platforms, sensitivity, background, specificity, positive controls, detection reagents, normal serum pools, tittering strategies, effect of circulating drug and cut-off models and statistical analysis to determine assay cut-off, and characterization of anti-drug antibodies.

In addition, case studies will be used to illustrate safety issues, methods development, interpretation of study data, and examples of statistical models for cut-off and assay design.