Gyros Introduces Series of Kits for Bioprocess Analysis

Gyros AB, a pioneer in miniaturizing and automating immunoassays at nanoliter-scale, has introduced a series of new kits for analysis in bioprocess workflows. The new kits comprise Gyrolab™ CHO-HCP Kits 2-5 and two Gyrolab Human IgG Titer Kits for rapid quantification of IgG. Combined with the automation and high throughput of Gyrolab systems, GyrolabxP workstation and Gyrolab xPlore™, these kits facilitate increased productivity in process development and release testing.

The four new Gyrolab CHO-HCP Kits 2-5 quantify host cell proteins (HCP) from Chinese hamster ovary (CHO) cells used in bioprocessing of biotherapeutics. Gyros now supplies five Gyrolab CHO-HCP Kits, including Gyrolab CHO-HCP Kit 1 launched in May. Gyrolab CHO-HCP Kits 2–5 are based on antibodies from BioGenes GmbH Berlin, Germany, and each kit contains antibody preparations that have been generated in different species using slightly different antigens. The Kits have broad dynamic range and show low intra- and inter-assay variation. Optimized for use with the Gyrolab platforms, the kits provide consistent and sensitive assay performance without the need for assay development, thus simplifying evaluation and selection of the optimal generic CHO-HCP kit.

The new Gyrolab Kits for determination of human IgG, Gyrolab huIgG Kits, which come in two configurations, High Titer and Low Titer, have been developed to accurately and robustly quantify intact human IgG (IgG1, IgG2 and IgG4) during cell line development. With broad dynamic ranges of 3-4 logs for each kit, determination is enabled from 1 ng/ml up to 1 mg/ml IgG concentrations. Reliable methods to determine IgG titer, to identify IgG-producing clones or to assess the outcome of optimizing cell lines or cell cultures, are essential to ensure efficient process development.

Gyros’ kits are validated for use on the nanoliter-scale microfluidic systems Gyrolab xP workstation and Gyrolab xPlore. The automation capabilities of Gyrolab systems enable 96 data points to be generated in approximately one hour without manual intervention, saving time, and reducing errors and repeats. These systems are in use in GLP and GMP environments in most of the top biopharma and CROs across the world. Gyrolab xPlore, launched earlier this year, is a smaller, single-CD version of the widely used five-CD Gyrolab xP workstation. A more compact and cost-effective tool, Gyrolab xPlore makes automated nanoliter-scale immunoassays accessible to laboratories of every size. Gyrolab systems optimize immunoassay development, enabling faster assay development, validation and high-throughput analyses in less time than with manual ELISA or semi-automated methods.

Dan Calvo, CEO, Gyros AB, commented: “Gyros is committed to developing tools for our bioprocess customers that support data-driven decisions. These new easy to use kits provide accurate and reproducible solutions for early process development through to QC release testing, maximizing productivity while meeting the quality required by the regulatory and medical community.”

The new kits will be showcased at BioProduction 2015 on 14-15 October in Dublin, Ireland, and at BPI 2015 on 26-29 October in Boston, MA.