Immunogenicity testing is a regulatory requirement as part of the safety assessment of biotherapeutic submissions. ADA immunoassays for biotherapeutics are complex and require lengthy protocols to maximize drug tolerance, minimize drug interference and establish equilibrium, such as overnight incubations and acid sample pre-treatment. Gyrolab™ ADA solution provides a nanoliter-scale method for automated acid pre-treatment in a Gyrolab Mixing CD with 96 microstructures, or this flexible solution can be also used without acid dissociation.

Gyrolab ADA solution enables customers to automatically run drug-tolerant ADA assays in a time-efficient way with small volumes of patient samples and reagents, reducing hands-on time, and shortening run-times. The Gyrolab ADA protocol and dedicated analysis software, designed for 21 CFR Part 11 compliance, streamline workflows from assay development through to screening and confirmation. Gyrolab ADA assays exhibit high drug tolerance and deliver sensitivity and consistent performance providing quality data.

Dr. Jasmine Gruia-Gray, VP Marketing, Gyros Protein Technologies, said: “Biotherapeutic pharmacokinetics and drug efficacy can be impacted by adverse immune responses to these drugs. In patients, the resulting anti-drug antibodies can also cause allergic reactions, anaphylactic shock, or autoimmunity. Due to the severity of the side effects in patients, regulatory agencies require pharmaceutical companies to perform immunogenicity studies as part of their biotherapeutic development programs. The Gyrolab platform is widely used for pharmacokinetic assays, and with 70% of scientists performing both pharmacokinetic and ADA assays, a high sensitivity, more automated ADA solution is critical.

This latest version of our ADA solution increases efficiency and throughput, providing double the capacity of the previous Gyrolab Mixing CD. With automated assay workflows, results can be obtained in as little as one hour, and with duplicates only requiring 5 µL sample, the use of precious reagents and patient samples is minimized.”

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