Ready-to-use kit expands range of bioanalysis kits, and enables generic detection of immune complexes in rodent samples

Uppsala, Sweden: Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale 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, the Kit Reagents provide a ready-to-use solution to accelerate screening of biotherapeutic drug candidates during preclinical development, enabling immunogenicity assessment of drug candidates without the need for drug-specific ADA assay development.

The new Kit Reagents expedite bioanalysis by removing the need for assay development and optimization across molecules to provide robust, reproducible, reliable data from nanoliter sample volumes. This is beneficial when ADA assessment 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 understanding of clearance profiles and safety or efficacy issues resulting from immune complex formation. The Gyrolab Generic Rodent ADA Kit fills an industry-wide need for a generic assay solution to expedite immunogenicity assessment.

The new bioanalysis 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, the Gyrolab Generic Rodent ADA Kit Reagents further expand the utility of the Gyrolab platform into earlier drug screening and preclinical phases of development. Automation with Gyrolab systems reduces variability due to manual pipetting and speeds up workflows by generating 96 data points within 80 minutes, helping to accelerate the development of novel human IgG therapeutics. Additionally, the Gyrolab platform supports the development of drug-specific ADA assays in the later stages of drug development, using automated acid dissociation in the Gyrolab Mixing CD 96 and the dedicated Gyrolab ADA Software, enabling immunogenicity assessment all the way from discovery through every phase of clinical analysis.

Mark Vossenaar, General Manager, Biopharmaceutical Development Division, Gyros Protein Technologies, commented: “The addition of the Gyrolab Generic Rodent ADA Kit Reagents to our portfolio enhances 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 the pharmacokinetic and toxicokinetic bioanalysis space, our open Gyrolab platform provides a powerful tool to accelerate immunogenicity assessment at the preclinical stage.”

For more information: https://www.gyrosproteintechnologies.com/immunoassays/products/gyrolab-generic-rodent-ada-kit-reagents

About Gyros Protein Technologies https://www.gyrosproteintechnologies.com/

Gyros Protein Technologies enables bioanalytical solutions and peptide synthesis, helping scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab^® xPand, and Gyrolab xPlore™, and Gyrolab immunoassay kits are used by scientists at leading pharmaceutical, biotech, CRO, and CMO companies in the development and manufacturing of various biotherapies including those based on peptides, antibodies, cell and gene therapies and vaccines. Gyrolab immunoassays provide key workflow advantages of speed, automation, and low reagent usage, and assay quality advantages of wide dynamic range with robust precision and reproducibility in applications including pharmacokinetics/pharmacodynamics, immunogenicity, and analysis of bioprocess-related impurities. Our low to mid-scale peptide synthesizer platforms, PurePep^® Chorus, Symphony^® X, and PurePep^® Sonata+, and chemistries deliver uncompromising purity, flexibility, and quality synthesis for discovery and pre-clinical studies of simple to complex multifunctional peptides. Our peptide synthesis and bioanalytical solutions accelerate the discovery, development, and manufacturing of safer biotherapeutics. Gyros Protein Technologies is part of the Biopharmaceutical Development Division of Mesa Laboratories, Inc. (Nasdaq: MLAB).

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