This program projects focuses on the treatment of cancer using genetically modified T cells. Three of the four projects will undertake clinical trials during the course of the studies. These rely on the availability of a GMP manufacturing facility for the preparation of the cellular therapy products. The GMP Facilities at the Center for Cell and Gene Therapy have been in operation for more than 6 years. The Cell Processing Facility has considerable experience in the preparation of a wide variety of cellular products, including all that would be required for the projects in this application. It has been designated one of three National Somatic Cell Therapy Processing Facilities by the NHLBI under its Production Assistance for Cell Therapy Contract Program. It consists of more than 6,000 square feet of HEPA filtered, Class 10,000 space, divided into 8 cell preparation laboratories, a low temperature storage area, a Class 1,000 cell sorting and analysis laboratory, a large equipment area and a central supply facility. The Facility is well equipped to operate under GMP conditions, with extensive documentation systems, barcoding, environmental monitoring and quality assurance, control and improvement programs. Additional components of the Core are the Quality Control Laboratory, which performs in-house testing of cellular products and vectors, and is responsible for routine monitoring of Good Manufacturing Practices;and the Quality Assurance Group that ensures compliance with GMP and provides independent overview of all aspects of manufacturing and release. The GMP staff also have extensive regulatory experience and will liaise with the projects and Core A to facilitate translation of laboratory studies into feasible clinical trials. In summary, the Cell Processing Core is a vital component of the Program Project that will provide services that are essential to the implementation of the clinical studies in Projects 1, 3 and 4.
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