Quantitation of antibody- or protein-based therapeutics in complex animal or human matrices (blood, urine, CSF) is essential to determine exposure in regulated and non-regulated studies. Maximizing the efficiency of bioanalysis with high-quality data and high throughput early in preclinical development is important since there is often a need to support multiple therapeutic candidates and multiple programs. Gyrolab Generic PK and TK assays with compatibility to rodent, canine, or non-human primate matrices are convenient to use in these phases to avoid assay development between molecules, speed up time to results, and minimize sample volumes.
In GLP-compliant regulated bioanalysis, drug-specific, validated assays are typically required. Gyrolab® platform is an open system for easy assay development, with fast run times that dramatically reduce assay development time from weeks to days. Multiple assays and conditions can be run in parallel or on different segments within the Gyrolab Bioaffy™ CD consumable.
One Mouse, One PK Profiile: Three full PK profiles from three rodents; IV administration of a therapeutic antibody. (Data courtesy of AstraZeneca)
Gyrolab immunoassays supporting preclinical pharmacokinetic studies offer benefits in reduction of sample volume and assay time, with broader dynamic ranges compared to ELISA and other plate-based methods:
The nanoliter volume requirements of Gyrolab systems enable researchers to obtain an entire PK from a single mouse which significantly reduces the number of mice used and the biological variability of PK endpoints. Obtaining a PK profile from a single mouse using serial sampling is an animal-sparing strategy consistent with the 3R research initiative that has been established at multiple biopharmaceutical companies with the Gyrolab platform. This animal-sparing strategy reduces the number of mice needed for a preclinical PK study by 60-80% which not only improves data quality but is also consistent with the principles of the 3R's. Reduction of sample volume requirements on Gyrolab platforms is especially useful when test articles are in short supply.
Read the case study, "One Mouse, One PK…the Magic of Capillary Microsampling and Gyrolab® Immunoassays"
Automation of PK bioanalysis on Gyrolab platforms provides higher throughput, minimal staffing, and faster analysis time while reducing the manual sources of error also improves overall method robustness. Since reagent use is greatly reduced, validated reagent batches can be stretched for the duration of the study, avoiding the need to re-validate new reagent lots.
"Gyrolab ... frees up time, maximizes group productivity and enables us to branch out into new realms. It has transformed our thinking about what we can achieve."
— Shawn Fernando, Morphotek Inc.
To hear more about what success looks like for one of our customers, Read the interview with Shawn Fernando, Morphotek Inc., on high-throughput PK assays in Phase II/III trials.
Want to learn more? Speak to our scientists about your application.