Pharmacodynamics (PD) & Biomarker Monitoring

Gyrolab^® technology helps extract the maximum pharmacodynamics (PD) information from limited sample volumes.

Biomarkers 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.

Merck custom biomarker assays

In further support of biomarkers, Gyros Protein Technologies has partnered with Merck (formerly EMD Millipore) to offer custom biomarker assays for the Gyrolab platform, using your antibodies or Merck's antibodies. For more information, please contact Merck.

Selection of biomarkers analyzed successfully on the Gyrolab platform

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