Immunogenicity 

Gyrolab^® delivers accurate immunogenicity assay results in a fraction of the time and with fewer manual steps.

Assessment of anti-drug antibodies (ADAs) as well as neutralizing antibodies (NAbs) is a fundamental part 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 feature/benefits for ADA immunoassays:

• Reduces hands-on time
  Automated sample pretreatment and assay workflows
• Shorten 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

Gyrolab ADA solution provides nanoliter-scale methods for ADA detection using automated acid dissociation or offline incubation. Working at nanoliter-scale reduces processing times and minimizes sample/reagent consumption.

Dedicated Gyrolab ADA software, 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.