Go Beyond your Expectations in Clinical PK, ADA, and Affinity Bioanalysis
Quick method validation
Data accepted for regulatory approval process
High tolerance across health and disease matrices
Minimal assay transfer time

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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For more clinical applications, see these links:
    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]
    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]

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