Celltrion's 23-acre facility is located at the center of the high-technology park in Songdo New City, a modern complex under development adjacent to the city of Incheon, South Korea. The facility is in close proximity to both the Incheon International Airport and downtown Seoul. Construction of Celltrion's 50,0000-liter capacity biopharmaceutical manufacturing facility is underway in Incheon, South Korea. This facility is being designed to comply with the cGMP (current Good Manufacturing Practices) Standards of the U.S. Food and Drug Administration and is scheduled to be ready for product recovery and purification by 2006. The facility's structure encompasses 215,000 square feet of process, process support, R&D and administrative space. The manufacturing area itself spans 82,000 square feet. The overall design concept behind the facility layout is predicated on wrapping the process and critical process support areas in a clean, safe, cGMP and regulatory compliant environment. Key adjacencies and spatial relationships have been optimized to facilitate the logical flow of personnel, raw materials, in-process product, clean/dirty equipment, and waste removal within the manufacturing environment. Architectural considerations maintain appropriate cGMP compliant levels of cleanliness and ease of cleaning. All heating, ventilation and air conditioning (HVAC) systems have been designed and selected to provide the necessary level of environmental control, pressure differentials and segregation of processing operations. All processing areas have been designed to provide operating environments of ISO-8 (USP - dynamic class 100,000) or better. Non-processing functions and equipment have been separated into "technical core" areas adjacent to the processing areas, wherever possible, to minimize the impact of maintenance and non-critical activities on the processing environment. The facility will have an initial total fermentation capacity of 50,000 liters and can be expanded to 150,000 liters based on client demand. The fermentation trains will utilize fed-batch or perfusion suspension cell culture technologies. The associated inoculum and downstream processing suites are designed with both centrifuge and depth filtration harvesting technologies. Process control systems are highly automated, and versatile purification suites will be suitable for a variety of biotherapeutic proteins such as monoclonal antibodies. In addition to the main fermentation and downstream processing suites, Celltrion will also house fully cGMP compliant cell banking, warehousing, utility systems and Quality Control laboratories to ensure efficient and successful manufacturing processes for our partners and clients. Celltrion's integrated departments and teams, including R&D, engineering, QA/QC, and manufacturing, as well as business services and marketing, work closely together to understand and address the business and technical needs of our partners. Conceptual design and preliminary engineering was performed by Fluor Corp., a leading U.S. engineering and design firm. Detailed engineering and construction are being performed by Bioengineering AG of Switzerland and Daewoo Engineering and Construction Co. of Korea.