This program project application focuses on the treatment of solid tumors using immunotherapeutic approaches. All four projects will include clinical trials as a component of the studies that require a GMP manufacturing facility for the preparation of clinical grade vectors and cellular therapy products. The GMP Facilities at the Center for Cell and Gene Therapy have been in operation for more than 13 years and have recently relocated to one of the largest and most modern academic facilities of its type. The Cell Processing Facility (CPF) has considerable experience in the preparation of a wide variety of cellular products, including all that would be prepared for the proposed projects. The CPF has been designated one of five National Somatic Cell Therapy Processing Facilities by the NHLBI under its Production Assistance for Cell Therapy Contract (PACT) Program. The Vector Production Facility (VPF), which is also be part of the Core, has produced more than 50 clinical grade viral vectors for local, national and international studies and was a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing clinical grade master and working cell banks. 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 environmental monitoring of the GMP areas; and the Quality Assurance Group that ensures compliance with GMP regulations and provides independent overview of all aspects of product manufacturing, testing, release and distribution. 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 will provide all of GMP-grade therapeutic products for the proposed clinical studies that are vital components of this application.
The goal of this core is to manufacture, in a safe manner with appropriate quality control, all of the vectors and cells that will be administered to patients on the proposed clinical trials that are part of every component project
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