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

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.

immunogenicity

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.

Gyrolab ADA Software Module

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

Want to learn more? Speak to our scientists about your application.

 

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