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 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.
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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