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

Pharmacokinetic (PK) testing plays a central role in understanding how therapeutic antibodies behave in the body, supporting the definition of dose, administration route and treatment schedule. In preclinical development, robust and sensitive assays are required to quantify antibody concentrations in complex biological matrices such as serum. This application note presents the development and qualification of a high‑performance PK assay using the Gyrolab platform to measure therapeutic antibodies in canine serum.

The full technical details, including validation data and experimental optimisation steps, are available in the complete application note below.

Impact on your bioanalytical workflows

This Gyrolab-based PK assay provides a robust and efficient framework for quantifying therapeutic antibodies in preclinical studies, supporting reliable decision-making throughout drug development. It:

• Enables high sensitivity detection of therapeutic antibodies in complex serum matrices
• Reduces sample volume requirements through microfluidic technology (20–4000 nL per test)
• Minimises matrix effects and variability, improving data reliability
• Supports automation, reducing hands-on time and human error
• Provides robust performance aligned with ICH M10 guidelines

Overall, the approach enhances the reliability and efficiency of PK data generation in antibody development programmes.

Analytical applications

• Quantification of therapeutic antibodies in canine serum during preclinical studies
• Support for PK profiling and dose optimisation
• Evaluation of efficacy and safety parameters of candidate antibodies
• Use in bioanalytical method validation workflows aligned with regulatory guidelines