Assessment of anti-drug antibodies (ADAs) is a fundamental requirement of immunogenicity testing of biotherapeutics during preclinical or clinical studies. ADA immunoassays 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.
Multiple antibody-based drug candidates are often evaluated in parallel using a small number of animals. The development of drug-specific ADA assays for each candidate can be impractical, however a generic ADA assay that detects human IgG in complex with anti-human IgG can be used without assay development between drug candidates. Learn more about generic ADA assays on the Gyrolab platform.
Sandwich assays using a drug product capture antibody and labeled drug product for detection are typically used for drug-specific ADA assays for measuring free ADA. Gyrolab ADA Solution (Gyrolab Mixing CD 96 and Rexxip ADA Buffer) automates drug-specific free ADA assays using the Gyrolab Mixing CD 96 for automated or offline acid dissociation which is often required to dissociate immune complexes.
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 ADA 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
Want to learn more? Speak to our scientists about your application.