Go Beyond your Expectations in Preclinical Bioanalysis

Go Beyond your Expectations in Preclinical Bioanalysis

Getting to clinic faster with more data sooner — PK, ADA, and affinity immunoassays to maximize performance and productivity

Rapid results from early preclinical PK, ADA, and affinity screening can move biotherapeutic candidates forward into development faster. With run times of about an hour for Gyrolab® immunoassays, delays in bioanalysis data supporting preclinical toxicology and safety studies can be avoided and deadlines met. Assay development using Gyrolab immunoassays can be completed in days, not weeks, keeping bioanalysis on track for preclinical toxicology and safety studies for biologics in development. Gyrolab microfluidic, flow-through affinity column assay format of the Gyrolab Bioaffy CD minimizes matrix interference, reducing the need for dilutions and sample re-runs, saving analyst time. 

One mouse, one PK

The low sample volume requirement of <10 µL has opened the door to utilization of serial sampling from one mouse to produce a complete PK profile. Microsampling approaches are in line with the principles of the 3Rs (ReplacementReduction and Refinement) for animal research, reducing the number of animals needed for preclinical PK analysis of biotherapeutics.

View a case study from Medimmune, "One mouse one PK: The magic of capillary microsampling and the Gyrolab assay platform", demonstrating the use of capillary microsampling to reduce the number of mice in each PK group from 20 to 4 and increase throughput in a preclinical PK study.

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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. 
    [Brochure]

    Gyrolab Kits and Solutions
    Gyrolab Kits, CDs and Rexxip Buffers - Designed for best results 
    [Brochure]

    Gyrolab CDs
    Select the appropriate CD for a specific immunoassay based on the required dynamic range, the analyte concentration, the quality of reagents and the assay format.  
    [Product information sheet]

    Gyrolab xPlore
    Gyrolab xPlore single-CD system automates high performance immunoassays throughout biopharma development and production. 
    [Product information sheet]

    Gyrolab xPand
    Gyrolab xPand five CD system optimizes immunoassay development, processing and performance in your laboratory. 
    [Product information sheet]

    Recorded webinar: Singlet Analysis Using Gyrolab® LBAs — New Normal in Abnormal Times
    Recorded webinar: Singlet PK analysis using Gyrolab® LBAs with workflow and assay cost advantages 
    [Webinar]

    White Paper: ADA — How to Maximize Drug Tolerance and Minimize Sample and Reagent Consumption
    This White Paper describes current regulatory requirements for ADA assays, approaches to choosing the right technology for ADA assays, and the advantages of Gyrolab for automating these assays. 
    [White Paper]

    Recorded Webinar: Rapid development and troubleshooting of robust microfluidic antibody-based therapeutic quantification for pharmacokinetic (PK) and toxicokinetic (TK) study support.
    In this presentation, data demonstrating rapid development of microfluidic, flow-through Gyrolab immunoassays leveraging 1-hour assay times and unique software Viewer features for assay troubleshooting is presented.  
    [Webinar]

    Recorded Webinar: Fast and convenient generic ligand binding assay for the detection of ADA in monkey using Gyrolab platform
    In this webinar, we will report a generic ligand binding assay for ADA detection in monkey studies during early phases of drug development. Firstly, we will show the advantages of our generic 4-step method on gyrolab platform and its performance against ADA specific methods. Then, we will present an approach to prepare a generic positive control and the cut-point strategy applied. Lastly, we will see this LBA format is transposable for a use in other species such as mouse. This webinar was presented on February 25, 2021. 
    [Webinar]

    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]

    Microfluidic, one-hour, total anti-AAV2 antibody assay in human serum using Gyrolab® platform
    Poster: Gyrolab method for rapid and accurate measurement of AAV2 immunogenicity 
    [Poster]

    Meeting evolving industry demands with smaller, faster and walkaway ligand-binding assays
    On-demand. In this webinar, we discuss the current state and outlook of the fast-growing biopharmaceutical industry with a special focus on the need for automation and speed in analytics, including customer case studies demonstrating performance and workflow improvements over traditional plate-based immunoassays such as ELISA in preclinical, clinical and bioprocess applications. 
    [Webinar]

    Immunogenicity:bioanalytical challengesand considerations
    In this eBook, we delve into the challenges of immunogenicity and important considerations when conducting immunogenicity studies. As the COVID-19 pandemic continues and vaccine efforts are ongoing, there has been renewed interest in the standardization and validation of immunoassays for immunogenicity. Download free from Bioanalysis Zone 
    [Ebooks]

    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]

    White Paper: Microsampling for bioanalysis
    Learn about microsampling in preclinical and clinical studies and the demands placed on ligand-binding assays, specifically Gyrolab immunoassays. 
    [White Paper]

    Recorded Webinar: Troubleshooting Labeled Reagent Issues in Gyrolab® Assays and How to Address ThemTroubleshooting Labeled Reagent Issues in Gyrolab® Assays and How to Address Them
    This informative presentation focuses on Gyrolab assay case studies that address issues with labeled reagents due to storage conditions and long-term stability parameters that were affecting assay performance. The tools used to discover the reagent issues and approaches to prevent them are presented. 
    [Webinar]