Biomarker Analysis: Pharmacodynamic Monitoring

Extract the maximum pharmacodynamics (PD) information from limited sample volumes.

Biomarker analysis provides prognostic, predictive, pharmacodynamic or surrogate endpoint information for a therapeutic intervention. Biomarker analysis can also assist in understanding the mode of action, target engagement in response to therapeutic administration, and pharmacokinetic (PK) endpoints.

Precise immunoassay methods are needed to measure biomarkers with qualification of performance characteristics that are fit for purpose to support different stages of biotherapeutic development. Biomarker immunoassays for preclinical safety toxicology studies require large sample volumes that necessitate pooling samples from multiple mice, have lengthy assay times, and lack dynamic range and sensitivity to meet study requirements. High MRDs and slow assay development also hinder biomarker fit-for-purpose assay development.

Gyrolab provides rapid and precise biomarker monitoring that addresses these challenges. The recent introduction of the Gyrolab Bioaffy™ 4000 CD expands Gyrolab assay sensitivity for a more powerful solution to biomarker analysis.

• High sensitivity & dynamic range
  Limits of quantitation down to sub-pg/mL levels
• Rapid time to results
  Results in about one hour with automated assay workflow
• Minimal sample dilution
  Reduce sample MRDs while minimizing matrix effects with affinity flow-through format and short contact times 
• Low sample consumption, multiple cytokine assays run in parallel
  As low as 4 µL of sample for duplicates maximizes analyses from limited serum samples 
• Biomarker panels run precisely
  Separate reactions with results with high sensitivity and assay quality

Low sample volume requirements 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.

Gyrolab assay protocols are available for these biomarkers to accelerate assay development: