This program project explores the enhancement of T cell therapy of cancer by employing viral vector technology. The projects span basic research as well as pre-clinical and clinical studies. For these diverse needs, two laboratories, the Clinical Gene Therapy Vector Laboratory and the Vector Development Laboratory, both within the Center for Cell and Gene Therapy at Baylor College of Medicine, will be employed to provide the appropriate vectors. These laboratories work closely together to develop novel vectors that can ultimately be produced under current Good Manufacturing Practices (cGMP) for clinical usage. The Vector Development Laboratory has expertise in the creation, production, and quality control testing of viral vectors for basic studies, and operates under Good Laboratory Practices (GLP). This facility also offers laboratory training to the investigators who will utilize these vectors and make available standard reporter vectors for feasibility testing. The second laboratory, the Clinical Gene Therapy Vector Laboratory, working closely with the Vector Development Laboratory, insures that novel vectors and attendant vector production and purification technologies, initiated under GLP, can be scaled up under cGMP guidelines. The Clinical Gene Therapy Vector Laboratory also ensures that all vectors produced for clinical studies will meet or exceed current standards as defined by the Food and Drug Administration. It is a well-established part of Baylor College of Medicine and has been strengthened by the close collaboration with the VectorDevelopment Laboratory. This section provides an overview of vector development and production within these two facilities as it pertains to the vectors described in Projects 1-3.
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