SOURCE: Cytovance Biologics

Cytovance Biologics

October 21, 2014 06:00 ET

Cytovance® Biologics Announces the Launch of Keystone Expression System™

OKLAHOMA CITY, OK--(Marketwired - Oct 21, 2014) - Cytovance Biologics, Inc., a full-service contract manufacturer of mammalian and microbial biologics with 10 years' industry experience, has announced the launch of its new Microbial expression platform, which it has named The Keystone Expression System™.

The Keystone Expression System™ is an E. coli expression platform using a toolbox approach to gene design, host construction, and screening evaluation. The platform uses a Quality by Design (QbD) approach from gene construction to GMP manufacturing. Proprietary vectors, E. coli hosts, and platform fermentation processes are designed to fit together for efficient and robust scale-up. Efficient work-flow enables early Master Cell Bank initiation with growth and titer data based on a fed-batch process that is scaleable and manufacturable.

Partnering with DNA2.0 GeneGPS™ Codon Optimization with Cytovance's Keystone Expression System™ creates an IP-free and robust method for developing an integrated manufacturing process that addresses challenges unique to each molecule. The Keystone Expression System™ circumvents pitfalls that typically arise in early phase manufacturing.

Dr. Jesse McCool, Senior Vice President of R&D Services at Cytovance, said, "Microbial strain development is a central element to a successful biomanufacturing process which has far reaching implications. With the development of the Keystone Expression System™, our goal has been to create a versatile and powerful expression toolbox that enables the rapid identification of a productive clone while maintaining alignment with biomanufacturing operational and regulatory requirements. The technology is IP- and royalty-free and represents cutting edge technologies and current best practices in plasmid design, host engineering and high-throughput clone screening workflows. This system will allow Cytovance to better serve its Phase I customers."

Dr. April Stanley, Head of Strain Development at Cytovance, adds, "As a bacterial geneticist, I do not look at E. coli hosts as a 'black box.' We understand the natural machinery of our workhorse. We developed this platform to avoid common problems with industry Research Cell Banks that generally require troubleshooting at a later stage. This platform is versatile enough to be useful for a wide range of E. coli products, while simplifying strain development and process development."

The Keystone Expression System™ will be expanded next year to include a corresponding CHO platform that is designed with the equivalent principle of host cell manipulation.

Cytovance will be unveiling the Keystone Expression System™ at the Bioprocess International Conference & Exhibition in Boston Oct 22-23, 2014.

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