The TCPC and its 4,700-square-foot clean room space are located in Seattle Children’s Research Institute’s newly refurbished Olive Lab in downtown Seattle. The facility, which includes six manufacturing suites, is registered with the FDA as a current Good Manufacturing Practices (cGMPs) manufacturing facility. These practices:
- Ensure consistent manufacturing of safe, pure and potent therapies.
- Require all tasks to be performed according to controlled, meticulously documented standard operating procedures, under a comprehensive quality plan. This plan includes oversight of the facility, equipment, personnel, cleaning, raw materials management, manufacturing, quality control tests and data review, documentation and change control, labeling and packaging, and the release of manufactured products.
- Mandate that all manufacturing operations are documented on controlled production records.
- Require that all manufacturing processes are performed by at least two production personnel. One staff member performs the manufacturing operation while the other person verifies that each process is performed correctly.
The clean room includes six manufacturing suites and follows strict guidelines to keep therapies pure. Each suite is pressurized to isolate it from the others, and all clean room air travels through a series of HEPA filters to remove dust and particulates before it enters the manufacturing areas. The air in the manufacturing suites is completely exchanged once every two minutes, and special equipment monitors the clean room to ensure it remains clean and free of microbial contamination.
Manufacturing personnel wear special head-to-toe gowning, including face masks, hair covers, suits, gloves and booties to ensure the cleanest possible environment for manufacturing tasks.