Biomarker Analysis: Pharmacodynamic Monitoring

Rapid and robust immunoassaysExtract the maximum pharmacodynamics (PD) information from limited sample volumes

Biomarker analysis provides prognostic, predictive, pharmacodynamic (PD), safety, or surrogate endpoint information for therapeutic interventions. 

Precise and robust fit-for-purpose biomarker immunoassay methods are needed to support preclinical and clinical biotherapeutic development, with single biomarker assay development typically occurring prior to preclinical studies of a drug candidate. Gyrolab immunoassays provide fully automated, robust assay performance with high precision, a wide dynamic range, and straightforward custom assay development, supporting biomarker analysis in regulated environments. 

The recent introduction of the Gyrolab Bioaffy™ 4000 CD expands Gyrolab assay sensitivity for a more powerful solution to biomarker analysis down to low pg/mL levels.

  • Robust and reliable biomarker quantification
    Reproducible data across operators and instruments and over long time periods
    Straightforward validation for regulated studies
    Software designed for 21 CFR Part 11 compliance
  • Fully automated, rapid time to results
    About one hour run times with automated assay workflow 
    Limit hands-on and in-lab time  
  • High sensitivity & wide dynamic range
    Low pg/mL sensitivity
    3-4 logs dynamic range 
  • Open platform for flexible assay development
    Flexible assay development for your immunoassay design and reagents
    Gyrolab assay protocols available for cytokine analysis
  • Biomarker assays run precisely with Gyroplex® panels
    Independent reactions with high sensitivity and quality results 

Biomarker quantification using Gyrolab platform positively impacts productivity in the development of therapeutics.

HubSpot Video

Gyrolab assay protocols are available for the cytokine and other biomarkers below:

Non-human primate

NHP IL-13 Human/NHP IL-2
NHP IL-8 Human/NHP IL-4
Human/NHP IFN-gamma Human/NHP IL-6

 

Human

Human GLP-1 Active Human IL-13 Human TNF-alpha
Human GLP-1 Total Human IL-2 Human VEGF
Human IFN-gamma Human IL-22 Human/NHP IFN-gamma
Human IL-1 beta Human IL-4 Human/NHP IL-2
Human IL-10 Human IL-6 Human/NHP IL-4
Human IL-12p70 Human IL-8 Human/NHP IL-6

 

Mouse

Mouse Erythropoietin (EPO) Mouse IL-17A Mouse TNF-alpha
Mouse IFN-gamma Mouse IL-22 Mouse IL-17A
Mouse IL-10 Mouse IL-4 Mouse IL-6
Mouse TNF-alpha    

 

Rat

Rat Clusterin Rat Erythropoietin (EPO) Rat KIM-1

 

Svar Flexi Solutions (Human Analytes)

Calprotectin Complement C4d TCC

 

Want to learn more? Speak to our scientists about your application.
 
Talk To Our Scientists
 
    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]

    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]

    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 
    [Webinar]

    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 
    [Webinar]

    Rapid and sensitive multi-biomarker analysis powered by Gyroplex™ panels on Gyrolab® Bioaffy™ 4000 CD
     
    [Application Note]

    Recorded Webinar: Extended sensitivity of biotherapeutic pharmacokinetic (PK) & biomarker immunoassays
    In this webinar, three speakers will present the application of microfluidic, nanoliter-scale Gyrolab® immunoassay platform for ligand-binding assays and the advantage of extended sensitivity using the Gyrolab Bioaffy 4000 CD. 
    [Webinar]

    Extended sensitivity of microfluidic immunoassays for pharmacokinetic (PK) and biomarker analysis
    Pharmacokinetic (PK) and biomarker analysis data down to low pg/mL levels is presented using the Gyrolab Bioaffy 4000 CD showing sensitivity expansion. 
    [Poster]