CORE--GENE THERAPY AND VACCINE VECTOR

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Description: (Applicant's Description) The Gene Therapy & Vaccine Vector Production Shared Facility is a new facility designed for the production of clinical grade biological pharmaceuticals which will be used in preclinical and clinical gene therapy and vaccine studies. Gene therapy vectors, both viral and plasmid, and proteins, e.g., vaccines and adjuvants will be produced in a preexisting, high containment building that has been renovated for the purpose. The physical plans for the facility have been approved by the Food and Drug Administration. A variety of funded projects require the services of the facility. Several of the gene therapy and vaccine projects have received previous approval by the NIH Committee for Recombinant DNA and two of the projects are either approved or are under review by the Food and Drug Administration. In addition to the product itself, the facility will provide testing and documentation to aid in the preparation of the applications for regulatory approval. The benefits of this shared facility will be a reliable, efficient mechanism for generation of early clinical trial reagents, the ability to carry out efficient movement through first, second and third generation reagents based on limited phase I trial data and reduced cost of reagent generation for clinical trials. The existence of this shared facility will allow UAB Cancer Center investigators to rapidly translate their laboratory observations to clinical trials. The primary rationale for this facility is to enhance the clinical development of novel vectors unique to the laboratory programs of our Cancer Center.