title: Immunogenicity testing strategy and bioanalytical assays for antibody-drug conjugates.
abstract: BACKGROUND
  Immunogenicity testing is an important component of clinical development for large-molecule biotherapeutics. New complex types of large molecules, such as antibody-drug conjugates (ADCs), require careful evaluation of the testing strategy and bioanalytical assays used to monitor the development of antitherapeutic antibodies.
  
  
  RESULTS
  An electrochemiluminescence-based immunoassay for the detection and epitope characterization of anti-ADC antibodies was validated. Using this assay format, antibodies directed against the monoclonal antibody and linker-drug components of the ADC were successfully detected in a multiple-dose rat toxicity study.
  
  
  CONCLUSIONS
  Immunogenicity assays incorporating epitope determination may provide additional information about the characteristics of induced antitherapeutic antibodies, including the magnitude and timing of the various types of antibody responses.
authors: Clinical Immunology, Amgen Inc., One Amgen Center Drive, 30E-3-B, Thousand Oaks, CA 91320, USA.
authors: Sarah A
authors: SA
authors: Hoofring
authors: Rocio
authors: R
authors: Lopez
authors: M Benjamin
authors: MB
authors: Hock
authors: Arunan
authors: A
authors: Kaliyaperumal
authors: Sonal K
authors: SK
authors: Patel
authors: Steven J
authors: SJ
authors: Swanson
authors: Narendra
authors: N
authors: Chirmule
authors: Marta
authors: M
authors: Starcevic
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood* / Q000276:immunology* / Q000627:therapeutic use; D000937:Antigen-Antibody Reactions; D006801:Humans; D018796:Immunoconjugates / Q000097:blood* / Q000276:immunology* / Q000627:therapeutic use; D055261:Immunogenetic Phenomena / Q000276:immunology*; D004364:Pharmaceutical Preparations / Q000097:blood*
chemical_list: D000911:Antibodies, Monoclonal; D018796:Immunoconjugates; D004364:Pharmaceutical Preparations