Gyros Protein Technologies AB, a pioneer in nanoliter-scale automated immunoassays and a leading provider of peptide synthesizers and reagents, today announced the introduction of Gyrolab® Generic Rodent Anti-Drug Antibody (ADA) Kit Reagents for the detection of circulating immune complexes of human IgG with rodent anti-human IgG. Validated for use with mouse and rat samples, Kit Reagents provide a ready-to-use solution to accelerate the screening of biotherapeutic drug candidates during preclinical development, enabling immunogenicity assessment of drug candidates without the need for drug-specific ADA assay development .
New Kit Reagents accelerate bioanalysis by removing the need for intermolecular assay development and optimization to provide robust, reproducible, reliable data from nanoliter sample volumes. This is advantageous when the ADA assay is evaluated in preclinical animal models where sample volume may be limited.
Monitoring of ADAs is essential in preclinical studies. Multiple drug candidates are often evaluated in parallel using a small number of animals to provide an understanding of clearance profiles and safety or efficacy issues arising from immune complex formation. The Gyrolab Generic Rodent ADA Kit fills an industry-wide need for a generic assay solution to accelerate immunogenicity assessment.
The new bioassay kit is optimized for use on all Gyrolab systems and complements the Company’s existing portfolio of ready-to-use kits and solutions for pharmacokinetics and toxicokinetics. Following the introduction of Gyrolab Generic Cyno ADA Kit Reagents, Gyrolab Generic Rodent ADA Kit Reagents further expand the utility of the Gyrolab platform in earlier drug screening and preclinical phases of development. Automation with Gyrolab systems reduces variability due to manual pipetting and accelerates workflows by generating 96 data points within 80 minutes, helping to accelerate the development of new human IgG therapeutics. In addition, the Gyrolab platform supports the development of drug-specific ADA assays in the late stages of drug development using automated acid dissociation on the Gyrolab Mixing CD 96 and proprietary Gyrolab ADA software, enabling immunogenicity assessment from discovery to every phase of clinical analysis .
The addition of Gyrolab Generic Rodent ADA Reagents to our portfolio strengthens our offering of ready-to-use kits and solutions for use in drug screening and preclinical development. Complementing our existing kits such as the Gyrolab Generic Cyno ADA Kit Reagents for use in non-human primates and our extensive offering in pharmacokinetic and toxicokinetic bioassays, our Gyrolab open platform provides a powerful tool to accelerate immunogenicity assessment in the preclinical stage.
Mark Vossenaar, General Manager, Biopharmaceutical Development, Gyros Protein Technologies
