Immunogenicity

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

ada-sw_smallImmunogenicity testing is a regulatory requirement as part of the safety assessment of biotherapeutic submissions. Anti-drug Antibody (ADA) immunoassays for biotherapeutics are extremely complex and subject to drug tolerance, sensitivity and labor intensive protocols that require lengthy protocols to maximize drug tolerance, minimize drug interference and establish equilibrium such as overnight incubations and acid sample pretreatment.

Gyrolab feature/benefits for immunogenicity immunoassays:

  • Reduces hands-on time
    Automated sample pretreatment and assay workflows
  • Shorten overall run times
    Results within 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 several nanoliter-scale methods for ADA detection using various Gyrolab CDs. 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.

Automating immunogenicity screening and confirmatory immunoassays

Automated sample pretreatment: Gyrolab Mixing CD Protocol                                                

Homogeneous Mix & Measure: Gyrolab 200 nl CD Protocol