Gyros Protein Technologies Introduces Gyrolab CHO-HCP E3G Kit for Impurity Testing of Biotherapeutics

Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and leading provider of peptide synthesizers and reagents, has introduced Gyrolab^® CHO-HCP E3G Kit for impurity analysis in the CMC (chemistry manufacturing and controls) – bioprocess workflow of biotherapeutics. The new kit is a valuable addition to the Gyrolab range of ready-to-use products, which are designed to increase productivity and reproducibility for scientists and engineers in bioprocess analysis. Gyros Protein Technologies has developed the kit as part of its licensing and supply agreement with Cygnus Technologies, using Cygnus’ gold standard 3G CHO-HCP ELISA reagents.

Gyrolab CHO-HCP Kits quantify residual host cell proteins (HCP) from Chinese hamster ovary (CHO) cells used in bioprocessing of biotherapeutics, one of the critical analytical steps in ensuring the safety of the therapeutic. Combined with the automation, performance and high throughput of Gyrolab systems, the new kits have a broad dynamic range and show low intra- and inter-assay variation, increasing productivity in host cell protein analysis in bioprocess development. Optimized for use with the Gyrolab platforms, the new Gyrolab CHO-HCP E3G kit provides consistent and sensitive assay performance without the need for extensive assay development. With further qualification of these antibodies in the customer’s assay, using sensitive orthogonal analytical services provided by Cygnus Technologies, it is now possible to identify the coverage to individual downstream HCPs and determine if a process-specific antibody and subsequent Gyrolab custom assay is required.

The Gyrolab immunoassay platforms, Gyrolab xPand, 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, affinity, IgG titer and quantitating bioprocess-related impurities. Gyrolab technology includes optimized, ready-to-use kits, which simplify assay workflows and shorten run times. Some users have reported a 40% reduction in project times versus alternative technologies. The proprietary Gyrolab CD technology, with highly reproducible nanoliter microfluidics, is integrated with Gyrolab platforms to automate nanoliter-scale immunoassays with parallel processing, using laser-induced fluorescence detection.

Dan Calvo, CEO and president, Gyros Protein Technologies, said: “The new CHO-HCP E3G kit gives Gyrolab customers access to industry-leading analysis tools for bioanalytical and bioprocess development, incorporating Cygnus Technologies’ gold standard reagents. The new products are an important addition to our growing portfolio of ready-to-use kits for analysis in bioprocess development and QC, helping customers to maximize productivity whilst meeting performance standards required by the regulatory community.”