Cytovance® Biologics operates from facilities at the OU University Research Park in Oklahoma City, Oklahoma.
cGMP manufacturing is performed 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 50,000 sq. ft. facility features primary production in cell culture suites featuring single-use bioreactors at 50L, 100L (w/v), 200L, 250L, and 1,000L and Stainless Steel bioreactors at 100L, 500L (w/v) and 1,000L (w/v) scale. Recovery and purification is undertaken in adjacent independent Purification suites.
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 process development laboratories, cGMP cell banking capabilities, 100L and 200L microbial fermentation suites and automated liquid fill/finish. Also featured are 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 is located in an adjacent third facility that also houses our administrative offices.
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