title: Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies.
abstract: Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.
authors.affiliation: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Michael A
authors.identifier: 0000-0001-6699-8473
authors.initials: MA
authors.lastname: Partridge
authors.affiliation: UCB Pharma, Slough, Berkshire SL1 14EN, UK.
authors.forename: Shobha
authors.identifier: 0000-0002-0015-1357
authors.initials: S
authors.lastname: Purushothama
authors.affiliation: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
authors.forename: Chinnasamy
authors.initials: C
authors.lastname: Elango
authors.affiliation: Department of Biochemical & Cellular Pharmacology, Genentech Inc., South San Francisco, CA 94080, USA.
authors.forename: Yanmei
authors.identifier: 0000-0002-2772-5154
authors.initials: Y
authors.lastname: Lu
mesh_terms: D000906:Antibodies / Q000032:analysis*; D000911:Antibodies, Monoclonal / Q000276:immunology* / Q000627:therapeutic use; D001691:Biological Therapy; D004361:Drug Tolerance; D004797:Enzyme-Linked Immunosorbent Assay; D004800:Enzymes, Immobilized / Q000737:chemistry / Q000378:metabolism; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods / Q000592:standards; D016133:Polymerase Chain Reaction / Q000379:methods
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D004800:Enzymes, Immobilized