Facilities
Cytovance® Biologics operates from three facilities at the Presbyterian Health Foundation Research Park in Oklahoma City, Oklahoma.
cGMP manufacturing is undertaken in our state-of-the-art primary production facility. This facility was custom-designed for cost-effective multi-product cGMP production of therapeutic proteins from mammalian cell culture and to meet the latest international regulatory standards, including current Good Manufacturing Practices (cGMP), the latest European regulations and International Standard ISO 14644 "Cleanrooms and Associated Enviroments". The facility design was reviewed in a Type C meeting with the US Food and Drug Administration prior to construction.
This 44,000 sq. ft. facility features primary production in cell culture suites featuring bioreactors at 100L (w/v) and 500L (w/v) scale under ISO 7 (previously class 10,000) classification. Recovery and purification is undertaken in adjacent independent ISO 7 suites. The facility also features an ISO 6 classification suite suitable for small scale cGMP liquid fill and finish operations.
Rapid expansion is possible in an additional ISO 7 primary production suite and the facility also features approximately 6,000 sq. ft. of expansion space that will accommodate multiple larger scale bioreactors.
In addition to the primary cGMP production facility, Cytovance operates an adjacent 6,000 sq. ft. cGMP clean room facility that houses our cell banking operations and features four additional suites that are available for pilot production or for operating custom processes. These clean rooms are available on a customer-dedicated basis if required.
Quality control and process development laboratories are located in an adjacent third facility that also houses our administrative offices.
