CORE--GENE THERAPY AND VACCINE VECTOR

描述：（申请人描述）基因治疗和疫苗载体 生产共享设施是一个新的设施，旨在生产 将用于临床前的临床级生物药品 临床基因治疗和疫苗研究。基因治疗载体， 病毒和质粒，以及蛋白质，例如，将生产疫苗和佐剂， 在一个已经存在的，高遏制建设，已被翻新的 目的.该设施的实物计划已获得食品和药物管理局的批准。 药品监督管理总局.各种受资助的项目需要以下服务： 设施。几个基因治疗和疫苗项目已经收到了 NIH重组DNA委员会的先前批准， 项目已获批准或正在接受食品和药物管理局的审查 局除了产品本身，该设施还将提供 测试和文件，以帮助准备申请， 监管批准。 这种共享设施的好处将是一种可靠、高效的机制 对于早期临床试验试剂的生成， 通过第一代、第二代和第三代试剂的有效移动， 有限的I期试验数据和降低试剂生产成本， 临床试验这种共享设施的存在将使UAB癌症 中心研究人员迅速将他们的实验室观察结果转化为 临床试验该设施的主要理由是加强 我们的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.