Developed to support assay development and validation for detection of anti-drug antibodies
Uppsala, Sweden, June 29th, 2017: Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and leading provider of peptide synthesizers and reagents, today announced it has launched a new version of its anti-drug antibody (ADA) solution for the immunogenicity market.
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 all 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 the 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.”
For more information please visit http://www.gyros.com/applications/immunogenicity/
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About Gyros Protein Technologies (For more information please click here)
Gyros Protein Technologies, enables peptide synthesis and bioanalytical solutions that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Our low to mid-scale peptide synthesizer platforms are the Tribute®, Prelude® X, Symphony® X, and Sonata®. These solutions and our chemistries deliver uncompromising purity, flexibility, and quality for discovery and pre-clinical studies of simple to complex multifunctional peptides. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab™xP workstation and Gyrolab xPlore™, are used by scientists in leading pharmaceutical, biotech, CRO, and CMO companies for bioanalytical applications such as pharmacokinetics/pharmacodynamics, immunogenicity, and quantitating bioprocess-related impurities. Our peptide synthesis and bioanalytical solutions accelerate your discovery, development, and manufacturing of safer biotherapeutics.