This program project explores the enhancement of T cell therapy of cancer by employing geneticmodification of ex-vivo expanded T cells in preclinical studies and clinical trials. For these diverse needs, twolaboratories, 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 providethe appropriate vectors. These laboratories work closely together to develop novel vectors that canultimately be produced under current Good Manufacturing Practices (cGMP) for clinical usage. The VectorDevelopment Laboratory has expertise in the creation, production, and quality control testing of viral vectorsfor basic studies and operates under Good Laboratory Practices (GLP). This facility also offers laboratorytraining to the investigators who will utilize these vectors and makes available standard reporter vectors forfeasibility testing. The second laboratory, the Clinical Vector Production Facility, which is also a part of theCore, has produced more than 20 clinical grade adenovectors for local, national and international studiesand is a National Gene Vector Laboratory for adenoviral vectors. It also has considerable experience inmanufacturing 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 ofGood Manufacturing Practices; and the Quality Assurance Group that ensures compliance with GMP andprovides independent overview of all aspects of manufacturing and release. The GMP staff also haveextensive regulatory experience that will facilitate the translational of laboratory studies into clinical trials. Insummary, the Vector Core is a vital component of the Program Project that provides services that areessential to the implementation of both preclinical and clinical studies.
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