CORE--GENE THERAPY AND VACCINE VECTOR

描述：(申请者描述)基因治疗和疫苗载体 生产共享设施是一种新的生产设施 将用于临床前研究的临床级生物药物 以及临床基因治疗和疫苗研究。基因治疗载体，两者 将生产病毒和质粒，以及蛋白质，例如疫苗和佐剂 在一座先前存在的、高度安全的建筑中，这座建筑已经为 目的。该设施的实物计划已经得到了食品和药物管理局的批准 和药品管理局。各种受资助的项目需要 这个设施。几个基因治疗和疫苗项目已经收到 之前由NIH委员会批准的重组DNA和两个 项目已获美国食品药品监督管理局批准或正在审查 行政部门。除了产品本身，该设施还将提供 测试和文档，以帮助准备应用程序 监管部门的批准。 这种共享设施的好处将是一个可靠、高效的机制 对于早期临床试验试剂的生成，能够进行 基于第一代、第二代和第三代试剂的高效移动 关于有限的I期试验数据和降低试剂生成成本 临床试验。这一共享设施的存在将使UAB癌症 中心调查人员将他们的实验室观察迅速转化为 临床试验。这项设施的主要原理是加强 我们实验室项目所特有的新型载体的临床开发 癌症中心。

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.