High-performance PK assay for biotherapeutic antibodies in dog serum: method development and qualification with the Gyrolab platform

Pharmacokinetic (PK) testing is essential for understanding the behaviour of a therapeutic drug within the body, which is crucial for determining its efficacy and safety. These assessments help define the appropriate dosage, route, and schedule of administration in preclinical and clinical studies. During the development of recombinant therapeutic antibodies, lead candidates must be evaluated in two preclinical species to ascertain their efficacy and safety parameters.

This study presents the development and qualification of a sensitive and specific Gyrolab-based PK assay for quantifying therapeutic antibodies in canine serum. The assay supports low sample volumes and is compatible with automation, enhancing throughput and reproducibility. Qualification results demonstrated good accuracy, precision, dilutional linearity, selectivity, and specificity.

Overall, the Gyrolab platform enables reliable monitoring of antibody levels, contributing to the safety and efficacy of antibody-based therapies.