clinical (2)

Go Beyond your Expectations in Clinical PK, ADA, and Affinity Bioanalysis

Maximize immunoassay performance and productivity with robust data throughout your clinical study

Assay stability throughout your biotherapeutics clinical study for PK, ADA, and affinity measurement is achievable with Gyrolab® microfluidic, automated immunoassay platform. The nanoliter-scale flow-through affinity column design allows rapid analyte binding and results in about one hour. Assay development can be accomplished in as little as one day, speeding up method validation beyond your expectations based on plate-based methods. As a result, Gyrolab immunoassays provide high throughput bioanalysis for 24/7 data collection with stable assay results throughout the study. 

The flow-through column design of the Gyrolab Bioaffy CD minimizes potential matrix interference, reducing the need for dilutions of clinical serum samples or other biological matrices. Assay performance is consistent between instruments, facilitating the transfer of Gyrolab immunoassays to outside CRO partners, and Gyrolab software is designed for 21 CFR Part 11 compliance, with data accepted for regulatory submissions. 

Read about maximizing bioanalysis throughput from preclinical to clinical development.

In this summary of three case studies, PK and biomarker analysis are demonstrated from preclinical through late-phase clinical studies: "Maximizing productivity in biopharmaceutical research and clinical development."

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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, CDs and Rexxip Buffers
    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]

    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: 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]