Challenges in developing antidrug antibody screening assays

Robert Dodge is the Laboratory Director for Immunochemistryand Cell Biologyat Taylor Technology, a Pharmanet company in Princeton, NJ, USA. Taylor Technology is a contract research laboratory specializing in assay development and sample testing in a good laboratory practiceenvironment. Robert oversees a staff of scientists responsible for the development of assays for use in protein drug quantitation, antidrug antibody screening and biomarker detection. Protein drugs may elicit an immune response in the form of production of antidrug antibodies ( ADAs) by a subject. This ADAresponse may have serious safety implications for subjects or, at a minimum, may affect drug efficacy. Bioanalytical testing for antidrug antibodies has therefore become a required part of safety testing for subjects receiving protein drugs. Regulatory guidance and scientific white papersrecommend a tiered approach for bioanalytical ADAtesting. The first assay in the tiered testing scheme is a screening assay, which tests all subj...