This program project explores the enhancement of T cell therapy of cancer by employing genetic modification of ex-vivo expanded T cells in preclinical studies and clinical trials. For these diverse needs, two laboratories, the Clinical Vector Production Facility (VPF) and the Vector Development Laboratory (VDL), 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 makes available standard reporter vectors for feasibility testing. The second laboratory, the Clinical Vector Production Facility, which is also 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 Core relies on the Quality Control Laboratory in Core B, 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 Vector Core is a vital component of the Program Project that provides services that are essential to the implementation of both preclinical and clinical studies.
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