SOURCE: Cytovance Biologics

Cytovance Biologics

March 09, 2016 12:15 ET

Cytovance Expands Track Record for Robust Microbial GMP Products

OKLAHOMA CITY, OK--(Marketwired - March 09, 2016) - Cytovance® Biologics, Inc. a leading full service contract manufacturer of mammalian and microbial biologics announces expansion of the Keystone Expression System™.

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 address design problems before they arise.

Cytovance® Biologics has developed an E. coli expression platform using a toolbox approach to gene design, host construction, and screening evaluation. Partnering of DNA2.0's 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 and circumvents pitfalls that can arise in manufacturing.

"We have performed expression feasibility studies with eleven different products. The primary screening of each molecule was tested in 24 versions of E. coli within an 8-week time frame using an accurate and efficient work-flow," said April Stanley, M.S., Manager, Cell Line & Strain Development. Cytovance performed demonstration runs with some industrially relevant molecules. One such demonstration with hGH yielded 12g per liter in a platform high-cell density fermentation process.

"Cytovance does not charge a royalty for its expression system as is the case with many CMOs," said Ms. Stanley. "We charge a flat fee for the service. In 12 weeks, we provide our clients with 24 candidate strains accompanied by accurate fermentation manufacturability data. This data set is the starting point for future process development, which is a streamlined scope of work that focuses on robustness of the manufacturing process."

Ms. Stanley has 8 years' industry experience 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 System™. 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.

Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.

Cytovance provides unparalleled support to the biopharmaceutical market to take candidate molecules from the bench to commercialization.

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