Immunogenicity Analysis  

Gyrolab ADA solution

Robust immunogenicity immunoassay results in a fraction of the time and with fewer manual steps with Gyrolab®

Assessment of anti-drug antibodies (ADAs) as well as neutralizing antibodies (NAbs) is a fundamental requirement of immunogenicity testing during preclinical or clinical studies. ADA immunoassays for biotherapeutics using plate-based methods can be extremely complex and require lengthy protocols to maximize drug tolerance, minimize drug interference and establish equilibrium, using methods such as overnight incubations and acid sample pretreatment.

Gyrolab microfluidic ADA immunoassays provide accurate analysis of anti-drug antibodies, from assay development through confirmatory analysis, in less time using less sample. Gyrolab ADA immunoassays are performed on a nanoliter scale with automated, CD-based formats on Gyrolab instrument platforms. Less than 2 hour run times are typical for Gyrolab ADA assays, with consistent assay performance and a wide dynamic range provided by Gyrolab buffers and CDs.

Gyrolab streamlines ADA immunoassays:

  • Reduces hands-on time
    Automated sample pretreatment and assay workflows
  • Shortens overall run times
    ADA assay results can be obtained in as little as one hour
  • Saves precious reagents and samples
    5 µL sample is sufficient for duplicates
  • Streamlines workflows from assay development through screening to confirmation:
    Gyrolab ADA immunoassay protocol and dedicated Gyrolab ADA analysis software simplify assay setup and cut point analysis

Gyrolab ADA solution provides nanoliter-scale immunoassay methods for ADA detection using automated acid dissociation in the Gyrolab Mixing CD 96 during a method, or with offline incubation. Working at nanoliter-scale reduces processing times and minimizes sample and reagent consumption.

Read our White Paper: ADA — How to Maximize Drug Tolerance and Minimize Sample and Reagent Consumption

Dedicated Gyrolab ADA software with automated cutpoint analysis and designed for  21 CFR Part 11 compliance, facilitates data analysis for either screening or confirmatory results. Gyrolab systems produce assays exhibiting high drug tolerance coupled with high sensitivity and consistent performance providing high quality data.


To accelerate assay development, Gyrolab assay protocols are available to for mAbs and biosimilar therapeutics: View Gyrolab ADA assay protocols

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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. 

    Gyrolab ADA solutions
    Gyrolab ADA solution provides nanoliter-scale methods for ADA detection using automated acid dissociation or offline incubation. Dedicated software facilitates data analysis for either screening or confirmatory results.  
    [Product information sheet]

    Evaluation of Gyrolab™ and Meso-Scale Discovery platforms in the development of a clinical immunogenicity assay
    J Collet, A Moreau et. al. NovImmune SA, Geneva, Switzerland 

    Sabrina Lory Developing fit-for-purpose immunoassays
    Recorded Seminar: Sabrina Lory, Head of the Bioanalytical Assay Laboratory, NovImmune, presents ‘Developing fit for purpose assays using the Gyrolab platform'. 

    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. 

    Developing and Validating a Gyrolab ADA Assay to address drug tolerance and small sample volume
    Recorded Webinar: Presenter Katrina Olson, Senior Associate Scientist, Pfizer, Andover. In this recorded webinar, Katrina describes the development of a Gyrolab bridging ADA assay, and the challenges that were surmounted in the development process. 

    Development of sensitive ADA assays using automated acid dissociation in Gyrolab Mixing CD 96
    In this webinar, Sarah Collomb from Novimmune SA will present an example of the development of a pre-clinical ADA assay using Gyrolab Mixing CD 96. 

    Optimizing ADA assay tolerance towards drug product using automated acid dissociation in an automated, microfluidic format
    In this webinar, John Chappell presents data demonstrating Gyrolab high sensitivity, high-quality, and drug-tolerant ADA immunoassays with automated acid dissociation. 

    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: 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. 

    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 

    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 

    The use of automation in the bioanalytical lab
    In this special eBook we explore the latest developments in laboratory automation. During the COVID-19 pandemic, the pharmaceutical industry has adapted by dispersing staff essential to laboratory workflows on staggered schedules. The implementation of a fully integrated laboratory system, that manages all aspects of operation and communication, can allow personnel working both on- and off-site to have access to current projects including status, laboratory activities and batch runs. Download free from Bioanalysis Zone