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

Biomarkers-analyzed-successfully-on-the-Gyros-platform.png

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

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

    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'. 
    [Seminar]

    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'. 
    [Seminar]

    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. 
    [Webinar]

    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. 
    [Webinar]

    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. 
    [Webinar]

    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. 
    [Webinar]