title: Platform switching from ELISA to Gyrolab™: a novel generic reagent omits the need to change critical reagents.
abstract: During development of biotherapeutics, availability of specific assay reagents is usually limited. The possibility to switch from one ligand binding assay technology to another, while using the same reagents, would be desirable. Here, we report on an Alexa647(®)-labeled monoclonal antibody against digoxigenin (mAb<Dig>-Alexa647(®)) that enables the detection of digoxigenylated analyte-specific ELISA reagents by Gyrolab(™). In an analysis of non-monoclonal antibody (mAb) and mAb drugs, this approach maintained the dynamic range, accuracy and precision of the standard Gyrolab™ approach using analyte-specific Alexa647(®)-labeled Ab. In a rat PK study, results of our approach, standard Gyrolab™ and ELISA were comparable, with difference values within the incurred sample reanalysis acceptance criteria. Therefore, mAb<Dig>-Alexa647(®) enables an easy switch between ELISA and Gyrolab™, providing an effective way to benefit from both platforms.
authors.affiliation: Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Germany.
authors.forename: Gregor
authors.initials: G
authors.lastname: Jordan
authors.affiliation: Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Germany.
authors.forename: Miriam
authors.initials: M
authors.lastname: Moheysen-Zadeh
authors.affiliation: Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Heinrich
authors.affiliation: Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Global DMPK & Bioanalytical R&D, Roche Innovation Center Munich, Germany.
authors.forename: Roland F
authors.initials: RF
authors.lastname: Staack
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D002232:Carbocyanines / Q000737:chemistry; D004076:Digoxigenin / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D006207:Half-Life; D007118:Immunoassay; D051381:Rats; D011933:Reagent Kits, Diagnostic
chemical_list: C569686:Alexa Fluor 647; D000911:Antibodies, Monoclonal; D002232:Carbocyanines; D011933:Reagent Kits, Diagnostic; D004076:Digoxigenin
keywords: Alexa647®; ELISA; Gyrolab™; LBA; PK; assay transfer; biotin; digoxigenin