Cytovance® Biologics operates from three facilities at the Presbyterian Health Foundation Research Park in Oklahoma City, Oklahoma.

cGMP manufacturing is undertaken in our new, state-of-the-art primary production facility. Construction was completed in 2006 and validation concluded in early 2007. 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 Environments". 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 a 2500-L bioreactor train, associated purification suites, and support areas.

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.

Primary cGMP Production Facility

• Multiple independent ISO 7 cell culture suites to 500L (w/v)
• Fed batch or perfusion culture
• Matched ISO 7 recovery and purification areas
• Full supporting infrastructure. Warehouse, glass wash, media/buffer preparation etc.
• Careful use of disposable technologies to maximize efficiency
• Full product segregation
• CIP/SIP
• Utilities (air, water etc.)
• In-process testing laboratory
• Additional suite available for rapid commissioning
• Significant expansion space to support larger scales of production
• ISO 6 suite suitable for small scale liquid fill/finish
• Ability to quickly add disposable technology capacity

cGMP Cell Banking and Storage Facility

This 6,000 sq. ft. facility houses our dedicated cGMP cell banking and storage practice and also features four additional large cGMP ISO 7 production clean rooms that are available for custom or dedicated customer processes.

Expansion Plan

Cytovance has committed to a facility and Capacity expansion as follows:

• 100L Disposable Bioreactor-On Line November 2008
• 500L Stir Tank Bioreactor and Down Stream Processing train-On Line June 2009
• 2,5000L Stir Tank Bioreactor and Down Stream Processing Train-On Line Jun 2010.