INTRODUCTION AND SCOPE

Anti-drug antibodies (ADA) can be induced when animal or human immune systems recognize a protein drug product as foreign. The administration of biopharmaceuticals can elicit product-specific ADA, and various types of ADA responses can develop in either nonclinical or clinical studies. Although the main focus of this chapter is ADA immunoassay design and validation, the chapter also includes discussion of an overall risk-based immunogenicity assay testing strategy that includes preclinical and clinical studies.