Pharmacodynamics (PD) & Biomarker Monitoring

Gyros’ technology helps extract the maximum pharmacodynamics (PD) information from limited sample volumes.

pd_smallBiomarkers are analytical measurements that provide information that can be prognostic, predictive, pharmacodynamic or act as a surrogate endpoint. Biomarkers assist in understanding the mode of action, enables the assessment of target engagement in response to therapeutic administration and has a direct relationship to pharmacokinetic (PK) endpoints. Assay methods are needed to measure biomarkers and qualification of performance characteristics are fit for purpose to support different stages of development.

Gyrolab feature/benefits for pharmacodynamics and biomarker monitoring:

  • Sensitivity & dynamic range
    Limits of quantitation down to single-digit pg/ml
  • Rapid time to results
    Automates assay workflow with results in 1 hour
  • Minimal sample dilution
    Affinity flow-through format with short contact times reduces sample MRDs while minimizing matrix effects
  • Low sample consumption
    4 µL sample is sufficient for duplicates, minimizing the number of animals needed while conserving precious samples and reagents for further studies

Biomarker assays in the development of therapeutics are often challenged with precious and limited sample volumes, high MRDs, and slow assay development for fit-for-purpose assays from discovery to clinical trials. Current immunoassay methods require sample volumes that necessitate pooling samples from multiple mice and lack dynamic range and sensitivity for testing early in development and safety toxicology. Miniaturizing and automating biomarker immunoassays on Gyrolab platforms at nanoliter-scale significantly reduces the volume, MRD and number of animals required for analyses producing immunoassays exhibiting broad ranges with picogram level sensitivity. It also allows for multiple analyte measurements from as little as 12 µL. Whether in discovery or in the regulated environment, biomarker assays using Gyrolab platforms positively impact sensitivity, throughput, performance and productivity in the development of therapeutics.

GyroMark™ HT biomarker kits

In further support of biomarkers, Gyros has partnered with EMD Millipore (Merck Millipore outside North America) to produce Ready to Use GyroMark™HT biomarker kits that are fully QC’d and validated for use on Gyrolab platforms. GyroMark HT kits contain all the components you need to efficiently complete your project in days instead of weeks. EMD Millipore also has the expertise and staff to develop custom kits, using your antibodies or EMD Millipore’s antibodies.

For the latest availability and information on GyroMark HT assay kits, visit our partner at EMD Millipore website.

GyroMark HT Kit advantages:

  • Fully qualified, robust and reproducible assays
  • High correlation to ELISAs and Luminex® assays
  • Order specific lots of reagents to minimize variation and lot-to-lot drift
  • Off-the-shelf kits including all the components to run an assay
  • EMD Millipore has over 25 years’ experience in kit development

Biomarkers analyzed successfully on Gyros’ platforms

Biomarkers analyzed successfully on the Gyros platform

All assays were performed in-house or at customer sites using commercially-available reagents.