150,000 SF cGMP Manufacturing Facility
Genesis provided architectural and engineering services for a new 150,000 SF cGMP manufacturing facility dedicated to clinical cell therapy and viral vector production. Designed for multi-platform flexibility, the two-story facility separates autologous therapy workflows from BSL-2 containment operations while providing cleanroom environments meeting EU Grades B through D.
Spatial Layout & Containment Strategy
The building layout isolates distinct processing streams across two dedicated floors:
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Floor 1 (Autologous Cell Therapy): Configured for clinical-scale autologous cell therapy manufacturing with controlled access and dedicated process suites.
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Floor 2 (Viral Vector Production): Houses segregated BSL-2 suites for viral vector manufacturing, ensuring physical separation from primary cell processing areas to protect product integrity.
Processing Technology & Equipment Integration
The facility infrastructure supports diverse upstream and downstream processing methods, accommodating both traditional and single-use technologies:
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Scale-Up Platforms: Designed to handle roller bottles, cell stacks, hyper stacks, and wave bags.
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Bioreactor Suites: Accommodates packaged stainless steel bioreactor systems and single-use bioreactors up to 2,000 liters.
Cleanroom Suites & Clean Utilities
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Graded Environment: Cleanroom zones are classified to meet EU Grade B, C, and D operational standards.
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Process Utilities: Engineered complete clean utility supply networks, including Water for Injection (WFI), Clean Dry Air (CDA), Carbon Dioxide (CO2), Oxygen (O2), Nitrogen (N2), and Reverse Osmosis/Deionized (RO/DI) water.
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Monitoring Infrastructure: Integrated continuous environmental monitoring systems to maintain strict microbial and particulate compliance across all classified spaces.
#14074, 15217