All four of the projects in this SPORE include clinical trials using cellular immunotherapy. These 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, recently relocating 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 SPORE 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 Program. The Vector Production Facility, which would also be a part of the Core, has produced more than 50 clinical grade adeno and retroviral vectors for local, national and international clinical studies and was a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience in manufacturing master and working cell banks. The final components of this 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 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 translation of laboratory studies into clinical trials.
The Cell Processing and Vector Production Core manufactures cells and vectors that are given to patients on clinical trials in a safe manner with appropriate quality control. It is an essential component of the SPORE since it provides services that are vital to the implementation of the clinical studies.
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