Analytical measurement of biomarkers provides information that can be prognostic, predictive, pharmacodynamic or act as a surrogate endpoint for a therapeutic intervention. Biomarker bioanalysis can also assist in understanding the mode of action, assessment of target engagement in response to therapeutic administration, and may have a direct relationship to 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 development.
Biomarker assays in the development of biotherapeutics 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, have lengthy assay times, and lack dynamic range and sensitivity for testing early in development and safety toxicology.
Gyrolab provides rapid and precise biomarker monitoring that addresses these challenges:
Miniaturizing and automating biomarker immunoassays on Gyrolab platforms at nanoliter-scale significantly reduces the sample volume, MRD and number of animals required for analyses providing immunoassays exhibiting broad dynamic ranges with picogram level sensitivity. 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: