This SPORE focuses on the treatment of lymphoma using immunotherapeutic approaches. Four of the fiveprojects will initiate clinical trials during the course of the studies. This depends on the availability of aGMPmanufacturing facility for the preparation of the vectors and cellular therapy products. The GMP Facilities atthe Center for Cell and Gene Therapy have been in operation for more than 6 years. The Cell ProcessingFacility has considerable experience in the preparation of a wide variety of cellular products, including all thatwould be prepared for the SPORE projects. It has been designated one of three National Somatic CellTherapy Processing Facilities by the NHLBI under its Production Assistance for Cell Therapy ContractProgram. The Vector Production Facility, which would also be a part of the Core, has produced more than20 clinical grade adenovectors for local, national and international studies and is a National Gene VectorLaboratory for adenoviral vectors. It also has considerable experience in manufacturing clinical graderetroviral 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 GoodManufacturing Practices; and the Quality Assurance Group that ensures compliance with GMP and providesindependent overview of all aspects of manufacturing and release. The GMP staff also have extensiveregulatory 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 servicesthat are essential to the implementation of the clinical studies.
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