Pharmacokinetics (PK)/Toxicokinetics (TK)

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    Pharmacokinetics (PK)/Toxicokinetics (TK)

Reduce sample volume and assay time for PK and TK immunoassays

Pharmacokinetic (PK) and toxicokinetic (TK) bioanalysis is an essential step at all stages of development to determine the dose and exposure of biologics in regulated and non-regulated studies. Maximizing the efficiency of bioanalysis with high-quality data and high throughput is important since early in development, there is a need to support multiple therapeutic candidates and multiple programs. Preclinical studies are subject to aggressive timelines and large sample numbers in a variety of species with limited sample and reagent volume available.

In GLP-compliant regulated bioanalysis, more robust methods with higher throughput and assay precision are essential for decision-making in compressed project timelines. Preclinical and clinical PK studies require increased method robustness and reliability as these assays are continually validated and used for long-term study support. Where specific PK assay development is needed, Gyrolab immunoassays dramatically reduce assay development time from weeks to days, since multiple assays and conditions can be run in parallel or on different segments within the CD consumable. Application of Gyrolab technology for PK and TK bioanalysis provides versatility and flexibility at all stages of biotherapeutic development in an automated, nanoliter-scale format.

 

Three full PK profiles from three rodents; IV administration of a therapeutic antibody. (Data courtesy of AstraZeneca)

One Mouse, One PK Profiile: Three full PK profiles from three rodents; IV administration of a therapeutic antibody. (Data courtesy of AstraZeneca)

Rapid PK assays, high-quality data

Gyrolab immunoassays supporting preclinical pharmacokinetic studies offer benefits in sample volume, assay time, and broader dynamic ranges compared to ELISA and other plate-based methods:

  • Broad dynamic ranges up to 6 logs
    Reduce sample dilutions and avoid re-runs
  • Accelerated assay time with 1 hour assays
    Faster decision-making, keep study timelines on track
  • Low sample and reagent volumes
    A <10 µL sample volume allows serial mouse sampling and more assays per sample for animal matrices
  • Automated microfluidic immunoassays
    Increases method robustness and optimizes lab efficiency

One mouse, one PK profile

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 strategy reduces the number of mice needed by 60-80% which not only improves data quality but impacts cost reductions in maintaining animal colonies, husbandry needs/facilities and removal of biological wastes. The ability to execute a one mouse, one PK profile strategy on Gyrolab platforms is especially useful when test articles are in short supply, rank ordering of PK with more than three test articles and with rare animal disease models.

Read the case study, "One Mouse, One PK…the Magic of Capillary Microsampling and Gyrolab® Immunoassays"

Generic preclinical PK immunoassays accelerate time to results

In biotherapeutic discovery and development, a flexible assay design is critical to support multiple species and programs with large numbers of samples, conditions, and limited reagents. Gyrolab Generic PK assays allow for a platform approach to quantitate multiple human mAbs in animal sera, increasing automated throughput capacity for proof of concept and rapid assessment of lead candidate identification and optimization.

 Gyrolab Generic TK Kits are based on the same reagents as the PK kits but use different Gyrolab Bioaffy CDs that differ in sample volume to shift the concentration ranges higher, meeting the higher dosing requirements for TK studies.

What success looks like

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.

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