The CMC ICOS Biologics Manufacturing plant has been in operation for the production of clinical products since 1997.

Major areas and facilities:

• Class 100,000 area for cell culture/fermentation
• Class 10,000 area for purification
• Class 100 room for final filtration and processing
• Cell banking/cell bank storage area
• Microbiological laboratory to support environmental monitoring
• Analytical laboratory to support in-process testing
• Microbial fermentation to 1,600 liters, cell culture production to 3,000 liters
• A separate building is used to warehouse raw materials, and a cGMP program is in place for shipping and receiving products and raw materials.

The CMC ICOS Biologics Engineering and Facilities Department maintains the plant utilities around the clock, and supports the ongoing preventive maintenance and equipment calibration programs. A validation master plan is in place, and the critical support equipment, cold rooms, and critical utilities are fully validated.

The production facility has passed numerous consultant and partner audits.

Map and directions to CMC ICOS Biologics.