Solving Selectivity Issues in LBAs: Case Study Using Gyrolab to Quantify CB307, a Bispecific Humabody in Human Serum.
Bioanalysis（2024）SCI 4区SCI 3区
Resolian | Crescendo Biol Ltd | Univ Surrey
Abstract
Aim: 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.Results: 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.Conclusion: 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 pharmacokinetic sample analysis in the first-in-human POTENTIA clinical study (NCT04839991) as a secondary clinical end point.
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Key words
CB307,disease state,Gyrolab,humabody,immunoassay,LBA,matrix effects,MRD,PK,selectivity
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