This Biosafety Level 3 (BSL-3)/GMP core facility will be responsible for providing laboratory support for gene therapy research designed to limit HIV infection. Three laboratories combine to form the BSL-3/GMP core facility and provide a unique environment in which to pursue both preclinical and clinical gene therapy research. The three laboratories that make up the core facility include the Biological Containment Laboratory, the Vector Core Laboratory, and the Human Applications Laboratory. The Biological Containment Laboratory contains two BSL-3 suites. One suite is a dedicated laboratory for preclinical experiments using infectious human pathogens. This laboratory will be used to test the effect of gene therapy vectors on HIV infection in preclinical studies. The second BSL-3 suite is a specialized facility designed to received and transduced patient cells with vectors prepared by the Human Applications Laboratory. The second BSL-3 suite will also be used during the course of clinical trials to perform molecular assays with patient samples to determine the efficacy of the gene therapy. The Vector Core Laboratory will construct, prepare, and characterize large amounts of both viral and non-viral vectors for use in preclinical gene transfer experiments. The Vector Core Laboratory also operates in collaboration with the University of Michigan site of the National Gene Vector Laboratory (NGVL) that will provide non-viral DNA vectors produced under GMP conditions for use in clinical research studies. The third facility is the Human Applications Laboratory, a newly designed facility that is dedicated to culture of both human cells and viral vectors for use in human gene therapy trials. This laboratory will provide a clean and controlled environment for optimal GMP conditions that are required to prepare viral vectors for gene transfer into cells that will be reinfused into patients. The combination of the three laboratories that comprise the BSL-3/GMP facility results in unique pooling of knowledge, expertise, and resources to enhance the ability to develop gene therapy strategies at the laboratory bench and to translate this research into clinical trials using gene therapy in HIV infected patients.
| Curran, Michael A; Ochoa, M Sofia; Molano, R Damaris et al. (2002) Efficient transduction of pancreatic islets by feline immunodeficiency virus vectors1. Transplantation 74:299-306 |
