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 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