Application of Gyrolab, an Automated Microfluidic System, to Regulated Bioanalysis of a Therapeutic Antibody in...

A microfluidic ligand binding assay platform, Gyrolab, has been employed for the analysis of biotherapeutics due to its high-throughput capabilities and reduced assay development time. In this study, Gyrolab was utilized to quantify E6011, an anti-fractalkine monoclonal antibody, in monkey serum. During method development, the concentrations of critical reagents and the minimum required dilution (MRD) were optimized. A 10 μL aliquot of serum samples was subjected to an MRD of 1:100, and E6011 in naïve serum was quantified over a range of 0.1 to 100 μg/mL. Validation parametersincluding calibration curve, prozone effect, carryover, selectivity, assay reproducibility, dilution integrity, and the effect of the target proteinwere evaluated along with platform-specific parameters such as inter-disc variability and stability at the MRD. All validation criteria were met. The assay was subsequently applied to a pharmacokinetic (PK) study of E6011 in monkeys. PK data obtained using Gyrolab were compared with results from a previous study using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The PK parameters estimated by the Gyrolab assay were consistent with those obtained by LC-MS/MS, supporting the robustness of the Gyrolab platform and its viability as an alternative assay method for biotherapeutics.