The Cellular Therapy Laboratory at Hackensack University Medical Center is composed of approximately 2,050 square feet and has been designed to optimize the performance of its entire operation with 900 square feet dedicated to developmental research and general administrative functions and the remaining 1,150 square feet for clinical laboratory activities. Currently, preparation of cells for over 220 transplants annually is performed through this room, with a maximum capacity of over 1200 per year. Over 700 procedures are performed in this area, with maximum capacity of approximately 2,500 per year. The 1,150 square foot clinical laboratory suite (the Clean Room) has been engineered to meet with access, containment and air quality specifications, consistent with the current Good Manufacturing Practices (cGMP) typically observed in the pharmaceutical industry. The Clean Room specifications meet the highest standards of air quality, directional flow and cleanliness required for the performance of a range of clinical laboratory activities, including standard cell processing through the most sophisticated cellular manipulations. This space is subdivided into 5 rooms, with varying levels of environmental control, each optimized for a specific set of activities.

• Room 131; Gowning (80 square feet): Personnel access to the Clean Room is controlled through Room 131, an air-lock design Gowning Room. Within this secure space, authorized personnel scrub and gown prior to entrance into the work areas. It is through this space as well that all supplies and reagents required to perform the laboratory activities enter the facility.
  

• Room 136; Accession and Distribution (100 square feet): All human cellular products gain access to and are distributed from the facility through a wall pass-through, directly into and from Suite 130 (Accession and Distribution). Here, each product is formerly received by the staff and logged into the Laboratory Accessioning system. The processing orders are verified and the work assignments are made. At the completion of processing and following preparation for release (Distribution), each cell product receives its final examination and is packaged within this room. It is issued through either one of two wall pass-throughs, depending upon whether it will be transported to another facility or transfused to a patient in the adjoining Outpatient Transfusion Room, where the patients will receive their cellular therapy.
  

• Room 133; Cellular Therapy Laboratory (500 square feet): The largest of the rooms in the clinical laboratory suite is the Cellular Therapy Laboratory and is where the more routine cell processing activities are performed. The room provides Class 100,000 air quality an its activities include, but are not limited to, Hematopoietic Progenitor Cell cryopreservation, Donor Leukocyte preparation, and CD34 selections. In addition, cellular assays designed to assess the functional viability, cellular characteristics and effectiveness of the products for their intended use are performed in this room.
• Room 132; Ex vivo Expansion (360 square feet): This Class 10,000 hepa-filtered space represents is the larger of two spaces within the suite that meet this stringent air quality specification. This room is equipped with the pre-production version of the Aastrom Cellular Production System (RepliCell) designed for ex vivo expansion of bone marrow, placental cord blood, dendritic cells, gene insertion and other human cell manipulations for transplantation. There are currently 12 RepliCell Incubators available in this room and depending upon the patients' treatment protocols, cells from between 3 and 11 patients can be processed at any one time. The room has been designed with space for at last 12 additional RepliCell Incubators, bringing the maximum load capacity to between 7 and 23 patients. ·
• Room 134; Thawing and Preparation (110 square feet): This Class 10,000 hepa-filtered space represents is the smaller of two spaces within the suite that meet this stringent air quality specification. Preparation of cells for infusion takes place within this room using protocol-specific procedures. Activities include, but are not limited to thawing washing and labeling of cellular products for distribution.
  

Adjacent to and connecting the remainder of the facility and the Clean Room is the 200 square foot Freezer Room. Hematopoietic Progenitor cells are cryopreserved and stored, in the frozen state within this area, until required by the patient. The facility is capable of storing over 2,400 products at any one time within continually monitored conditions 24 hours each day. Storage temperatures are maintained through the use of liquid nitrogen (LN2) at temperature ranges between -85°C and -196°C, depending upon the treatment protocol and intended duration of storage. LN2 is continuously available and supplied from a 950 Liter bulk supply system located at the ground level, four floors directly below the laboratory. Due to its unique dual access points, the freezer room also provides a route for personnel and refuses to exit the Clean Room space without risk of cross-contamination of the Gowning Room.

The remaining 700 square feet is divided into General Administrative (560 square feet) and Developmental Research space (140 square feet). Within the Research Laboratory, up to two Research Scientists can evaluate, refine, scale-up and validate new procedures for transfer into the Clean Room. In this way, HUMC is capable of providing the most current technologies to its patients in the highest quality manner. The General Administrative space contains offices for the Director and Manager of the Laboratory, a Conference Room, a receptionist and storage for general supplies.