CORE--GENE THERAPY AND VACCINE VECTOR

基因治疗和疫苗载体生产共享设施是为生产临床级生物药物而设计的新设施，这些药物将用于临床前和临床基因治疗和疫苗研究。基因治疗载体，包括病毒和质粒，以及蛋白质，如疫苗和佐剂，将在为此目的而翻新的预先存在的高密封性建筑中生产。该设施的实物计划已经得到了美国食品和药物管理局的批准。各种资助的项目都需要该设施的服务。几个基因治疗和疫苗项目之前已经获得了NIH重组DNA委员会的批准，其中两个项目要么已经获得批准，要么正在接受食品和药物管理局的审查。除了产品本身，该设施还将提供测试和文件，以帮助准备申请获得监管部门的批准。这种共享设施的好处将是生成早期临床试验试剂的可靠、高效的机制，能够基于有限的I期试验数据在第一代、第二代和第三代试剂之间进行有效的移动，并降低临床试验试剂生成的成本。这一共享设施的存在将使UAB癌症中心的研究人员能够迅速将他们的实验室观察转化为临床试验。这一设施的主要原理是加强我们癌症中心实验室计划特有的新型载体的临床开发。

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 pre- existing, 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 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 of 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.