OKLAHOMA CITY, OK--(Marketwired - October 21, 2014) -
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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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