Assay stability throughout your biotherapeutics clinical study for PK, ADA, and affinity measurement is achievable with Gyrolab® microfluidic, automated immunoassay platform. The nanoliter-scale flow-through affinity column design allows rapid analyte binding and results in about one hour. Assay development can be accomplished in as little as one day, speeding up method validation beyond your expectations based on plate-based methods. As a result, Gyrolab immunoassays provide high throughput bioanalysis for 24/7 data collection with stable assay results throughout the study.
The flow-through column design of the Gyrolab Bioaffy CD minimizes potential matrix interference, reducing the need for dilutions of clinical serum samples or other biological matrices. Assay performance is consistent between instruments, facilitating the transfer of Gyrolab immunoassays to outside CRO partners, and Gyrolab software is designed for 21 CFR Part 11 compliance, with data accepted for regulatory submissions.
In this summary of three case studies, PK and biomarker analysis are demonstrated from preclinical through late-phase clinical studies: "Maximizing productivity in biopharmaceutical research and clinical development."