Immunogenicity 

Gyrolab^® delivers accurate 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. ADA immunoassays for biotherapeutics are 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 feature/benefits for ADA immunoassays:

• Reduces hands-on time
  Automated sample pretreatment and assay workflows
• Shorten overall run times
  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 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.

 Gyrolab ADA Software

Assessment of neutralizing antibodies (NAb)