Cytovance Biologics, Inc. has expanded its Keystone Expression System to address obstacles for researchers using the Gram-negative bacterium, E. coli, related to cost of goods, scale-up challenges, or in-process control.

Cytovance Biologics has developed an E. coli expression platform using a toolbox approach to gene design, host construction, and screening evaluation. According to the company, partnering of DNA2.0’s GeneGPS Codon Optimization with its 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, 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.”