Vaccine and Cell Therapy Core: Services
The Vaccine and Cell Therapy Shared Resource occupies 1,800 square feet of the 7th floor of the Rusk Research (RR) Building, within the NYU Medical Center complex on East 34 Street in New York City. It features three class 10,000 (ISO 7) clean rooms for the production of therapies, and one non-classified laboratory for immunology research. The clean rooms are accessed through a series of classified gowning rooms, and access is controlled by identification card swipe. There is a magnetic door interlock system that permits only one door in a group to be opened at a time, which restricts the flow of both air and personnel.
The laboratory's modular design allows multiple projects to be performed simultaneously. The separation of manufacturing processes and products reduces the possibility of laboratory errors such as mix-ups or cross-contamination. The facility has a dedicated air-handling system that supplies single pass, HEPA-filtered outdoor air to all rooms. Its design was approved prior to construction at a meeting with the FDA in 2003. Construction was completed in late 2005, and validation testing was completed by mid-2007.