Cell and Vector Production

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This SPORE focuses on the treatment of lymphoma using immunotherapeutic approaches. Four of the five projects will initiate clinical trials during the course of the studies. This depends on the availability of aGMP manufacturing facility for the preparation of the vectors and 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 prepared for the SPORE projects. 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. The Vector Production Facility, which would also be a part of the Core, has produced more than 20 clinical grade adenovectors for local, national and international studies and is a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing clinical grade retroviral vectors. The final 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 that will facilitate the translational of laboratory studies into clinical trials. In summary, the Cell Processing and Vector Production Core is a vital component of the SPORE that will provide services that are essential to the implementation of the clinical studies.