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New immunoassay kits Improve Biotherapeutic Development and Production Workflows

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Cygnus Technologies provides specialized analytical products to the pharmaceutical and biotechnology industry for testing biologics and their impurities during process development and quality control. The two new Cygnus kits have been developed to test for impurities, namely Host Cell Proteins from CHO and E. coli.  Scientists optimizing purification processes and working in process control, routine QC and product release testing will benefit from the convenience of ready to use kits while maximizing their efficiency by utilizing the automated immunoassay platform from Gyros.

Ken Hoffmann, President at Cygnus Technologies, explained: “Having concluded that the nanoliter-scale immunoassay format of the Gyros solution can be the most beneficial approach for many of our customers, we believe that these kits will further accelerate assay development timelines and increase lab productivity.”

At Radix Biosolutions, a US-based contract research organization specializing in custom assay development, reagent manufacturing, and a provider of assay services, the Gyrolab™ xP workstation is used in development programs. The goal of the new immunoassay kit is to provide analytical measurements for customers that need to evaluate the pharmacokinetics of their antibody-based biotherapeutics in low-volume samples.  The kit has been developed under Fit-for-Purpose standards and the core principles of the 21st Century Bioanalytical Lab Initiative to ensure highest performance and facilitate lab to lab harmonization.

Commenting on the announcement, Erik Walldén, CEO at Gyros, added: “Major biopharmaceutical companies and their service providers, CROs and CMOs, use our platform to increase the productivity and efficiency of their workflows. To have such well-established providers independently develop kits to meet specific demands of our clients demonstrates the growing recognition that Gyros is setting a standard for immunoassays utilized in time-critical workflows. Users of Gyrolab workstations can cut assay development times down to days compared to the weeks required for conventional techniques. The convenience of kits will further transform lab productivity.”

Kits will be sold and supported through Cygnus Technologies and Radix Biosolutions, as appropriate.