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

@article{Jani2015FeasibilityOI,
  title={Feasibility of immuno-PCR technology platforms as an ultrasensitive tool for the detection of anti-drug antibodies.},
  author={Darshana Jani and Edward Savino and J. M. Goyal},
  journal={Bioanalysis},
  year={2015},
  volume={7 3},
  pages={285-94}
}
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… CONTINUE READING