Oklahoma City, OK - February 17, 2016 Cytovance® Biologics, Inc. a leading full service contract manufacturer of mammalian and microbial biologics announces expansion plans for Keystone Expression SystemTM.
The Gram-negative bacterium, E. coli, is a true workhorse in the biopharmaceutical industry and has a well-established track record of FDA approval and commercialization. Despite its broad utility, many commercial expression strains pose risks or obstacles in terms of cost of goods, scale-up challenges, or in-process control. Researchers often lack the manufacturing or E. coli genetics expertise to design out problems before they arise.
Cytovance has developed an E. coli expression platform using a toolbox approach to gene design, host construction, and screening evaluation. Partnering DNA2.0 GeneGPSTM Codon Optimization with Cytovance’s Keystone Expression SystemTM creates an IP-free and robust method for developing an integrated manufacturing process that addresses challenges unique to each molecule and circumvents pitfalls that can arise in Phase I manufacturing.
“We are currently making eleven products which provides 24 versions of E. coli and are able to test these strains one at a time, with an 8-week turn-around time frame, providing our clients with accurate and efficient work-flow data,” said April Stanley.
“Cytovance does not charge a royalty fee like other CMO’s,” said April Stanley, “we charge a flat fee for the work with accurate timelines and fermentation manufacture ability data.” Cytovance has performed demo runs with hGH, proving how fast our products work. The data supports 12g a liter over a 12-week period.
Ms. Stanley has 8 years’ experience industry with an array of technologies, including E. coli strain development, fermentation process development, technology transfer and scale up for microbial manufacturing, and Mammalian Cell Culture. At Cytovance April has designed and tested the Cytovance E. coli Keystone Expression SystemTM. This work, which encompassed genetic engineering of suitable E. coli hosts, establishing screening workflows, and developing platform fermentation processes to match strains learned from 10 years of contract biomanufacturing experience.