Facility
Facility Overview
The 6,000 sq. ft. Advanced Cellular Therapeutics (ACT) Facility includes 2,500 sq. ft. of ISO 7 clean room environment in six individual clean room suites.
Each clean room has independent air systems to minimize risk of cross-contamination and allows multiple projects to operate in parallel. In addition to the clean rooms, the ACT Quality Control Laboratory is utilized for release testing of products and other assays.
The ACT Facility operates under a comprehensive Quality Management system that includes documentation management, process controls, environmental monitoring, personnel training, deviations, adverse events, corrective actions, investigations, and regulatory compliance.
Facility features include:
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- Dedicated virus production clean room suite with negative pressure HVAC system.
- Central supply of CO2, air, and vacuum to multiple points in each clean room suite.
- Cell production rooms equipped with Class II(A2) biologic safety cabinets and CO2 incubators.
- Equipment for specialized procedures (e.g., CliniMACS cell immunomagnetic cell separator).
- Building and equipment monitoring systems providing 24/7 data capture with local and remote alarming.
- Controlled environment material management storage areas.
- Monitored, controlled access product storage room with including range of storage conditions including vapor phase liquid nitrogen freezers and ultralow temp mechanical freezers.
- Process development area for translation and scale-up work.
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