Vaccine and Cell Therapy Core Laboratory

The Vaccine and Cell Therapy Core Laboratory 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 (see Figure 1).  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.

 Figure 1.  Floor plan of the NYU Vaccine and Cell Therapy Core Laboratory

Vaccine Production

Two of the clean rooms (RR-714 and RR-715, non-viral) are identically equipped with two class II biosafety cabinets (BSCs), two refrigerated centrifuges, two tissue culture incubators, a pharmacy refrigerator/freezer, and an inverted microscope.  Room 714 is currently used for the preparation of emulsion vaccines, while room 715 is used for the production of therapeutic cells.  Room 715 is also equipped with a Guava PCA analyzer (used for viable cell counting) and a refrigerated microcentrifuge.  Both rooms are positively pressurized relative to the adjacent gowning rooms.

The third clean room (RR-729, Viral) has additional features of a biosafety level 3 (BSL 3) laboratory -- it is negatively pressurized, its BSCs are vented outdoors through HEPA filters, and it has one-way personnel flow, with its own dedicated gowning and de-gowning rooms.  This room is intended for work with microbial vectors or virally infected cells.  It is equipped with three BSCs, two refrigerated centrifuges, two tissue culture incubators, a pharmacy refrigerator/freezer, and upright and inverted research microscopes.  

cGMP Storage

The facility has two dedicated rooms for storage of frozen products and intermediates.  The viral storage room (RR-732) is equipped with -80°C and liquid nitrogen freezers, and is connected to the viral clean room (RR-729) by a negatively pressurized pass-through.  This design restricts the flow of infectious materials to only dedicated portions of the facility.  The non-viral storage room (RR-730) has two pharmacy refrigerators, a -80°C freezer, and two liquid nitrogen freezers. All refrigerators, freezers, and incubators in the facility are monitored continuously by a Rees Scientific eCentron equipment monitoring system with call-out capability.  

Immunology Research

The Immunology Laboratory (RR-710) has two BSCs, two tissue culture incubators, two refrigerated centrifuges, a refrigerated microcentrifuge, a pharmacy refrigerator/freezer, an undercounter -20°C freezer, and a Millipore pure water system.  Advanced equipment induces a Becton Dickinson LSR II flow cytometer (4 lasers, 18 colors), a Luminex 200 analyzer, a CTL ImmunoSpot ELISPOT reader, a SpectraMax M2 multifunction plate reader, a Guava PCA personal cell analyzer, a Miltenyi AutoMACS cell separation system, a GE Healthcare AKTA Basic chromatography system, two microscopes (one inverted and one stereomicroscope), a DNA Engine thermal cycler with real-time detector, a Bio-Rad GenePulser electroporator, and a Bio-Rad Chemidoc XRS gel imaging system. 

Becton Dickinson LSR II flow cytometer, equipped with 4 lasers (488 nm blue, 635 nm red, 405 nm violet, and 532 nm green) configured to detect 18 colors. 

GE Healhcare AKTA Basic chromatography system

Additional equipment includes a CryoMed controlled-rate freezer in RR-709 and a validated Steris steam sterilizer in the hallway outside the laboratory. The facility features two offices outside the laboratory which are equipped with several computers, including two powerful Mac Pro computers with FlowJo software for flow cytometry data analysis.

Due to space constraints, the core's equipment for molecular biology and radioactive work are located in the research laboratory of Nina Bhardwaj, MD, PhD, on the 13th floor of the Smilow Research Building.  These include a 96-well plate harvester, a micro beta liquid scintillation/luminescence counter, a bacterial shaker/incubator, a sonifier, an Agilent 2100 BioAnalyzer, a Beckman L-80XP ultracentrifuge, and a Beckman J-20XP high-speed, high-capacity centrifuge.  A cesium irradiator is also available nearby in space shared with the Department of Pathology.