The Therapeutics Cell Manufacturing facility and its 11,000-square-foot clean room space are located in Seattle Children's Research Division's newest research facility in downtown Seattle, Building Cure. The shift to this new building makes Seattle Children’s Therapeutics the highest capacity producer of pediatric CAR-T products for clinical trials in the U.S. The facility, which includes 12 clean room cell processing suites, as well as support areas such as final product vialing, final product storage, quality control labs and space for raw material storage, is registered 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 space 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. Clear and efficient organization of the cell production and support rooms provides opportunities to increase efficiency for staff operating multiple lots at various stages of production at a given time.
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.
These precautions have allowed the team to continue manufacturing therapies during the COVID-19 pandemic without stopping or pausing, and the Therapeutics Cell Manufacturing facility has now created products for children in every continent except Antarctica.
Learn how the Therapeutics Cell Manufacturing facility has changed the lives of children with pediatric disease, including Greta, who participated in a cancer immunotherapy trial at Seattle Children’s and has now been in remission for more than 6 years.