Biomarker Analysis: Pharmacodynamic Monitoring

Extract the maximum pharmacodynamics (PD) information from limited sample volumes.Biomarker-1

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:

  • High sensitivity & dynamic range
    Limits of quantitation down to low pg/mL
  • 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 in parallel
    Separate reactions with results as fast as multiplex assays with higher sensitivity and assay quality

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:

GLP-1 Active
GLP-1 Total
Mouse Erythropoietin (EPO)
Rat Erythropoietin (EPO)
Rat KIM-1
Complement C4d

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    Gyrolab Systems
    Gyrolab technology reduces manual labor, assay development time, time to result and material consumption -and it improves workflow efficiency. 

    Maximizing productivity in biopharmaceutical research and clinical development
    Three case studies are presented: "Obtaining an entire PK profile form a single mouse", "Earlier and more sensitive detection of drug-induced kidney toxicity in preclinical studies" and "Ramping up Phase II/III PK studies to meet critical deadlines". 
    [Application Note]

    Quantitation of active GLP-1
    GLP-1 is a gut hormone that is secreted in response to food intake, affecting both metabolism and weight. Since endogenous levels of GLP-1 are typically less than 5 pM in diabetes and obesity, the chosen method must have high sensitivity. Gyros Protein Technologies has developed an automated immunoassay for human active GLP-1 using commercially available reagents. 
    [Application Note]

    Mark Dysinger GLP-1 quantitation: Gyros vs. other detection platforms
    Recorded Seminar: Mark Dysinger, Senior Scientist, Pharmacokinetics, Dynamics, and Metabolism, Pfizer Global Research and Development, presents ‘Glucagon-Like Peptide 1 Quantitation: Gyros vs Other Detection Platforms'. 

    Diane Hamlin on the performance of Gyrolab xP workstation
    Recorded Seminar: Diane Hamlin, Eli Lilly and Company, presents 'Performance of the Gyrolab xP System for Custom Development of Preclinical Urinary Renal Biomarker Assays'. 

    Rapid Reagent Screening and Characterization using Automated Nanoliter-scale Immunoassays
    Recorded Webinar: Gyrolab is a reliable immunoassay platform that streamlines reagent selection and characterization during method development for biotherapeutics. Presenters: Frank Zambito, Research Scientist I, Bioanalytical Sciences, Bristol-Myers Squibb and Shawn Fernando, Senior Principal Researcher, Morphotek, Inc. 

    Using Automated Nanoliter-Scale Immunoassays for Improved Performance and Efficiency
    Recorded Webinar: Christophe Henry, Ph.D., Laboratory Head / Translational Medicine, Sanofi, presents case studies featuring reagent screening and method development for a variety of different biotherapeutics – traditional and non-conventional constructs. 

    Redefining 3Rs for Safety Toxicology Biomarkers using Automated Nanoliter-scale Immunoassays
    Recorded Webinar. Presenters: Diane Marie Hamlin, Investigative Toxicology, Eli Lilly and Wei Zheng, Immunoassays & Multiplexing, Bioscience, EMD Millipore. 

    Fit-for-Purpose Biomarker Assay Development and Validation using Automated Nanoliter-Scale Immunoassays
    Recorded Webinar. Presenters: Robert Durham, Ph.D., Gyros Inc., Chad A. Ray, PhD, Pfizer PDM, Kerry Oliver, Ph.D., Radix Biosolutions & Ariëlla Van de Sompel, Senior Research Associate, Ablynx. 

    A Gyrolab Assay for the Quantitation of Free Complement Protein C5a in Human Plasma96
    Please visit the recorded webinar. Presenter Mark Dysinger, M.S., Development Scientist III, Alexion Pharmaceuticals 

    Accelerating workflows for calprotectin and complement (C4d, TCC) biomarker immunoassays
    Recorded webinar: automated immunoassays for complement analytes C4d and TCC and calprotectin using Svar Life Science Flexi reagents and Gyrolab® platform