High-performance PK assay for biotherapeutic antibodies in dog serum: development and qualification with 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. A high-performance pharmacokinetic assay that measures the therapeutic antibody needs to be developed and validated. Such assays are required to be highly sensitive and specific, with the capability to detect low concentrations of antibodies in complex biological matrices. Furthermore, these assays should enable experimental analyses using small sample volumes and be amenable to automation to increase the throughput and reduce variability.

This application note outlines the development of a Gyrolab assay designed to quantify the concentration of a therapeutic antibody in canine sera. Subsequent to the development phase, the assay underwent qualification to assess its accuracy, precision, dilutional linearity, selectivity, and specificity.