{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["16(14)"],"submitter":["Wilford T"],"pubmed_abstract":["<b>Aim:</b> Endogenous interferents can cause nonselectivity in ligand binding pharmacokinetic assays, leading to inaccurate quantification of drug concentrations. We describe the development of a Gyrolab immunoassay to quantify a new modality, CB307 and discuss strategies implemented to overcome matrix effects and achieve selectivity at the desired sensitivity.<b>Results:</b> Matrix effects were mitigated using strategies including increasing minimum required dilution (MRD) and lower limit of quantification, optimization of antibody orientation, assay buffer and solid phase.<b>Conclusion:</b> The strategies described resulted in a selective method for CB307 in disease state matrix that met bioanalytical method validation (BMV) guidance and is currently used to support clinical pharmacokin"],"journal":["Bioanalysis"],"pagination":["757-769"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11389741"],"repository":["biostudies-literature"],"pubmed_title":["Solving selectivity issues in LBAs: case study using Gyrolab to quantify CB307, a bispecific Humabody in human serum."],"pmcid":["PMC11389741"],"pubmed_authors":["Wilford T","Bartlett PD","Hughes R","Schlag A","Pandha H","Jasaitis L","Pierce AJ"],"additional_accession":[]},"is_claimable":false,"name":"Solving selectivity issues in LBAs: case study using Gyrolab to quantify CB307, a bispecific Humabody in human serum.","description":"<b>Aim:</b> Endogenous interferents can cause nonselectivity in ligand binding pharmacokinetic assays, leading to inaccurate quantification of drug concentrations. We describe the development of a Gyrolab immunoassay to quantify a new modality, CB307 and discuss strategies implemented to overcome matrix effects and achieve selectivity at the desired sensitivity.<b>Results:</b> Matrix effects were mitigated using strategies including increasing minimum required dilution (MRD) and lower limit of quantification, optimization of antibody orientation, assay buffer and solid phase.<b>Conclusion:</b> The strategies described resulted in a selective method for CB307 in disease state matrix that met bioanalytical method validation (BMV) guidance and is currently used to support clinical pharmacokin","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024","modification":"2025-04-04T12:09:17.646Z","creation":"2025-04-04T12:09:17.646Z"},"accession":"S-EPMC11389741","cross_references":{"pubmed":["38957926"],"doi":["10.1080/17576180.2024.2365545"]}}