title: Feasibility of immuno-PCR technology platforms as an ultrasensitive tool for the detection of anti-drug antibodies.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Immuno PCR assay proved to be a feasible platform for anti-drug antibody characterization.
authors.affiliation: Translational Science & Technology, Biogen Idec, Inc., 14 Cambridge Center, Cambridge, MA 02142, USA.
authors.forename: Darshana
authors.initials: D
authors.lastname: Jani
authors.forename: Edward
authors.initials: E
authors.lastname: Savino
authors.forename: Jaya
authors.initials: J
authors.lastname: Goyal
mesh_terms: D000906:Antibodies / Q000032:analysis* / Q000097:blood / Q000276:immunology*; D001691:Biological Therapy; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D057230:Limit of Detection; D008163:Luminescent Measurements; D004364:Pharmaceutical Preparations; D016133:Polymerase Chain Reaction / Q000379:methods*; D011993:Recombinant Fusion Proteins / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D000906:Antibodies; D004364:Pharmaceutical Preparations; D011993:Recombinant Fusion Proteins