Calibration–free concentration analysis for quantification of anti-drug specific antibodies in polyclonal positive control antibodies and in clinical samples

Highly sensitive assays for anti–drug antibodies (ADAs) are both a regulatory requirement and requisite for proper evaluation of the effects of immunogenicity on clinical efficacy and safety. Determination of ADA assay sensitivity depends on positive control antibodies to represent naturally occurring or treatment–induced ADA responses. An accurate determination of the proportion of drug–specific antibodies in these polyclonal positive control batches is critical for correct evaluation of assay sensitivity.