Market Overview

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

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  • Incorporates Cygnus Technologies' gold standard reagents
  • Ready-to-use immunoassay kit designed to increase productivity

Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale
immunoassays and leading provider of peptide synthesizers and reagents,
today 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."

The new kit will be showcased at The Bioprocessing Summit 2018 on 13-17
August in Boston, MA.

ENDS

Notes to editors

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