Turn-Key Facility with Specialized Improvements
- Previously approved FDA & EMEA facility
- Located minutes from UCSD off the I-5 & in the heart of Southern California
- Capable of supporting clinical trials/commercial scale production
- Recent upgrades include facility re-commissioning and equipment re-qualification by previous tenant
- Advanced GMP clinical manufacturing, cell culture manufacturing and purification capabilities
- Versatile and adaptable architecture
- Process scale-up lab with epoxy floors and process utilities
- R&D and QC lab space available
Laboratories
Wet chemistry, biochemistry and microbiology for in-process and final product testing, scale-up laboratories for cell culture and purification and a decommissioned radiochemistry lab.
Manufacturing Clean Room Specifications
Temperature and humidity controlled clean room space segregated into four classified HVAC zones ranging from Class 10,000 to Class 100,000. Hoods capable of Class 100.
Manufacturing Capabilities
Seed lab, inoculum train (1 x 100L and 1 x 500L), production fermentors (2 x 2,750L) centrifuge/depth filtration system, and one harvest cell culture fluid (HCCF) tank. Media and buffer preparation, purification and formulation areas.
Facility Power and Storage
Emergency power generator capable of supplying 100% demand during peak load. Storage for ambient and hot WFI loops, USP purified water plant and clean steam, compressed air, carbon dioxide and nitrogen gas.
| Property Profile: |
| Building Size |
±76,694 sq. ft. |
| GMP Manufacturing |
±23,724 sq. ft. |
| Lab / Lab Support |
±34,181 sq. ft. |
| Administrative Office |
±12,993 sq. ft. |
| Vivarium* |
±3,325 sq. ft. |
| Maintenance/Engineering Office |
±2,089 sq. ft. |
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Comments & Terms
Current Sublease term expires September 30, 2011, Landlord will provide long term lease. The pilot plant has been previously upgraded in multiple renovation projects with over $23 million in tenant improvements.
*non-operational for past 5 years |
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