Feasibility of immuno-PCR technology platforms as an ultrasensitive tool for the detection of anti-drug antibodies.

Aim: During the early clinical development of a receptor-IgG1 fusion protein (Drug X), a risk based strategy was utilized to evaluate immunogenicity from Phase I through Proof of Concept clinical studies.

Materials & Methods: Three different technology platforms, enzyme-linked immunosorbant assay, electrochemiluminescent assay and newly emerging immuno-PCR were utilized for evaluation of immunogenic response.

Results: An ELISA with adequate sensitivity but significant drug interference was replaced by electrochemiluminescent method with improved drug tolerance; however, an inverse correlation was observed between the administered dose and the incidence of anti-drug antibodies. Further evaluation of an immuno-PCR showed reduced drug interference enabling the detection of anti-drug antibodies in the presence of excess amount of Drug X.

Conclusion: Immuno PCR assay proved to be a feasible platform for anti-drug antibody characterization.