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ARRA Investments in the NIH Department of Transfusion Medicine, Cell Processing Section

Public Health Burden
The $500 million ARRA Buildings and Facilities (B&F) program addresses high-priority repair, construction and improvement projects at NIH facilities in Bethesda, MD and Hamilton, MT.  The ARRA B&F program increases the research capacity of the NIH by providing new or upgrading existing biomedical facilities.  The plan also reflects the priorities embodied in the Recovery Act legislation for job creation and sustainable development.

The NIH Department of Transfusion Medicine, Cell Processing Section
The Cell Processing Section (CPS) of the Department of Transfusion Medicine (DTM) provides a wide range of cellular therapy services to support patient care and research at the NIH Clinical Center.  The CPS performs research aimed at development, evaluation, and validation of new manufacturing processes for cellular therapies and manufactures cellular therapy products for approved clinical trials.     The production of cellular therapies is complex, involving a number of steps that must be carefully orchestrated.  The steps must be completed in sequence at precisely the right time and under carefully controlled laboratory conditions.  Cellular therapy product manufacturing is further complicated by donor or patient genetic and physiological heterogeneity.  In spite of these complexities, cellular therapies must be safe, pure, sterile, stable, and potent.  To ensure that cell therapies have these properties, they are tested in many ways during and at the end of their production.  The products manufactured by the laboratory are used to treat and often cure Clinical Center patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases.

Project Overview
The CPS operates a facility for the manufacture, storage, and distribution of cellular therapy products on the 3rd floor of Building 10 on the NIH campus in Bethesda, MD.  The existing heating, ventilation, and air conditioning (HVAC) supply and exhaust systems as well as the HVAC controls servicing the CPS have exceeded their service lives and are beginning to fail.  Laboratory processes in the CPS are completed in a clean room environment where directional air flows are critical to the research operation.  HVAC systems failures jeopardize the manufacturing process as well as therapeutic materials in storage.   The ARRA B&F project replaces and upgrades HVAC systems and controls to continuously provide the stable environment required for cellular therapy production and storage, improves the energy efficiency of building systems, provides new bio-safety cabinets, as well as improves the efficiency of the laboratory through minor architectural changes.  System replacement of air handler and exhaust fan motors and associated variable frequency drives will reduce energy consumption and costs.  The installation of new piping and coil, with proper maintenance procedures to eliminate corroded mechanical piping systems, will reduce the time systems are down for emergency maintenance.  Other renovations within the laboratory unit funded with the ARRA appropriation include replacement of ducted bio-safety cabinets with unducted cabinets that protect cellular materials and exhaust air from work areas independent of the building’s exhaust system.  Existing light fixtures and access panels will be replaced to reduce the risk of pollutants entering the areas where cellular therapies are manufactured and stored.  Minor architectural changes to the layout of the laboratory will make the laboratory more efficient.    These ARRA funded improvements are being implemented in phases so that the CPS can continue using its tissue culture rooms for operations which are critical to the NIH.  The project is scheduled to be completed in early-2010.

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