Markets ServedCytovance Biologics' customers range from virtual biotechnology companies to major corporations. We focus on process development and early phase clinical projects where we are able to add value by accelerating projects and providing a high degree of flexibility. In addition to undertaking complete development projects we are happy to take-on smaller "standalone" projects and process troubleshooting or technology evaluation work. Our operations are supported by carefully designed quality laboratories, systems and procedures and highly experienced quality assurance and quality control staff.
Our comprehensive offering of process development services covers cell line development and selection through the design and development of cell culture and purification processes that are compliant, robust, scaleable, and economically viable. We also offer a comprehensive analytical development and validation capability. Cytovance offers a full cGMP cell banking and storage capability and the production of both preclinical and cGMP clinical material is provided at scales up to 500-L (w/v) bioreactors. Both fed-batch and perfusion capabilities are available.
We are happy to assist with the development of appropriate regulatory submissions and to attend meetings with international regulatory authorities. We offer considerable experience in technology transfer and fully assist in transferring processes out of, as well as in to, Cytovance Biologics. We have a successful track record of transferring processes for large-scale production at international third-party facilities.
Cytovance Biologics operates from three state-of-the-art facilities located on the Presbyterian Health Foundation Research Park in Oklahoma City, OK. The combination of these world class facilities, which meet international regulatory standards, and Cytovance's highly experienced management and technical staff allow us to offer service more usually anticipated from major multinational providers while maintaining the advantage of an attractive cost-basis that we share with our customers.
Our custom-designed 44,000-sq. ft. multi-product cGMP primary production facility features multiple cell culture suites with bioreactor working volumes up to 500 L. Both fed-batch and perfusion culture are available and are supported by appropriately scaled purification suites. This facility features expansion space that will allow delivery of larger scale production on either a multi-product or client-specific basis.
Cytovance's cGMP cell banking and storage practice is located in 6,000 sq. ft. of adjacent cleanroom space that also features three large cGMP processing suites for client-dedicated or custom processes. Extremely well equipped process development and quality laboratories are located in a third building adjacent to the manufacturing facilities.
CYTOVANCE BIOLOGICS LLC