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