title: Evaluation of Multiple Immunoassay Technology Platforms to Select the Anti-Drug Antibody Assay Exhibiting the Most Appropriate Drug and Target Tolerance.
abstract: The aim of this study was, at the assay development stage and thus with an appropriate degree of rigor, to select the most appropriate technology platform and sample pretreatment procedure for a clinical ADA assay. Thus, ELISA, MSD, Gyrolab, and AlphaLISA immunoassay platforms were evaluated in association with target depletion and acid dissociation sample pretreatment steps. An acid dissociation step successfully improved the drug tolerance for all 4 technology platforms and the required drug tolerance was achieved with the Gyrolab and MSD platforms. The target tolerance was shown to be better for the ELISA format, where an acid dissociation treatment step alone was sufficient to achieve the desired target tolerance. However, inclusion of a target depletion step in conjunction with the acid treatment raised the target tolerance to the desired level for all of the technologies. A higher sensitivity was observed for the MSD and Gyrolab assays and the ELISA, MSD, and Gyrolab all displayed acceptable interdonor variability. This study highlights the usefulness of evaluating the performance of different assay platforms at an early stage in the assay development process to aid in the selection of the best fit-for-purpose technology platform and sample pretreatment steps.
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Justine
authors.initials: J
authors.lastname: Collet-Brose
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Pierre-Jean
authors.identifier: 0000-0002-0709-5212
authors.initials: PJ
authors.lastname: Couble
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Maureen R
authors.identifier: 0000-0003-0813-9915
authors.initials: MR
authors.lastname: Deehan
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Robert J
authors.identifier: 0000-0003-4553-5415
authors.initials: RJ
authors.lastname: Nelson
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Walter G
authors.identifier: 0000-0001-5636-4450
authors.initials: WG
authors.lastname: Ferlin
authors.affiliation: Novimmune SA, 14 Chemin des Aulx, 1228 Plan-les-Ouates, Geneva, Switzerland.
authors.forename: Sabrina
authors.identifier: 0000-0001-7847-284X
authors.initials: S
authors.lastname: Lory
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology* / Q000627:therapeutic use; D004361:Drug Tolerance; D004797:Enzyme-Linked Immunosorbent Assay; D004800:Enzymes, Immobilized / Q000737:chemistry; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D007159:Immunologic Tests; D058990:Molecular Targeted Therapy; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D004800:Enzymes, Immobilized