Shared Resource: Cell Processing and Vector Production

共享资源：细胞处理和载体生产

• 批准号: 8934787
• 负责人: ADRIAN Philip GEE
• 金额: $ 7.6万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8934787
• 关键词: Adenovirus Vector; Annual Reports; Basic Science; Biological; Cancer Center; Cell Therapy; Cell physiology; Cells; Chemistry; Clinical; Clinical Data; Clinical Research; Clinical Trials; Contracts; Data; Development; Disease; Documentation; Focus Groups; Genes; Growth; Investigational Drugs; Investigational New Drug Application; Laboratories; Medicine; National Heart, Lung, and Blood Institute; Pharmaceutical Preparations; Phase; Preparation; Procedures; Production; Protocols documentation; Quality Control; Quality Indicator; Regulation; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Retroviral Vector; Services; Solid Neoplasm; Somatic Cell; Specific qualifier value; Speed; Testing; Therapeutic; Training; United States Food and Drug Administration; Validation; Viral Vector; Work; cancer therapy; college; experience; gene therapy; leukemia treatment; neoplastic; pre-clinical; preclinical study; programs; quality assurance; research study; stability testing; tissue repair; vector

CORE: Cell Processing and Vector Production Shared Resource (Clinical Focus Group) PROJECT SUMMARY Cellular and gene therapies are finding more widespread use in the treatment of leukemias and solid tumors, and in repairing tissues that have been damaged by these diseases.The number of Phase 1 cell and gene therapy Investigational New Drug applications (INDs) submitted to the Food and Drug Administration (FDA) has undergone exponential growth. A potential barrier to conducting such studies is the FDA requirement that these biological drugs must be manufactured under current Good Manufacturing Practices (GMP) regulations. These provide a highly documented framework that specifies the conditions for manufacturing, testing, releasing and distributing the therapeutic product. The Cell Processing and Vector Production Shared Resource at the Baylor Center for Cell and Gene Therapies provides Dan L. Duncan Cancer Center (DLDCC) investigators with access to a highly experienced, state-of-the-art GMP facility consisting of 22 manufacturing clean rooms, product analytical services, and Quality Control laboratories and Quality Assurance services. In addition, the GMP staff have extensive experience manufacturing a wide range of cellular products and viral vectors. They are also very familiar with the submission of regulatory documents to support IND applications. This resource can speed the transition of cellular and gene therapy products from the basic science laboratory into early-phase clinical trials. Traditionally this translational step has been a major impediment to starting IND studies. Staff of this DLDCC resource will work with investigators to develop clinical scale manufacturing procedures, release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. They will then provide both the clinical products for the trial, and summary data for annual reports. This service places DLDCC researchers at a distinct advantage when transitioning from research studies to clinical trials.

核心：细胞处理和矢量生产共享资源（临床焦点小组） 项目摘要 细胞和基因疗法正在发现在白血病和实体瘤的治疗中更广泛使用， 并修复已被这些疾病损害的组织时。1期细胞和基因的数量 提交给食品药品监督管理局（FDA）的治疗研究新药应用（IND） 经历了指数增长。进行此类研究的潜在障碍是FDA要求 这些生物药物必须根据当前的良好制造实践（GMP）法规制造。 这些提供了一个备有文献记载的框架，该框架指定了制造，测试， 释放和分发治疗产品。单元加工和矢量生产共享 贝勒细胞和基因疗法中心的资源提供Dan L. Duncan癌症中心（DLDCC） 可以使用经验丰富，最先进的GMP工厂的调查人员，该设施由22个制造业组成 干净的房间，产品分析服务以及质量控制实验室和质量保证服务。在 此外，GMP员工拥有丰富的经验，它们制造了广泛的蜂窝产品和病毒 向量。他们还非常熟悉提交监管文件以支持IND申请。 该资源可以加快基础科学实验室的细胞和基因治疗产品的过渡 进入早期临床试验。传统上，这一翻译步骤一直是启动IND的主要障碍 研究。该DLDCC资源的工作人员将与研究人员合作开发临床规模制造 程序，释放测试规格，测试程序，质量保证监督和监管 协助提交的协助。然后，他们将提供试验的临床产品，并且 年度报告的摘要数据。这项服务使DLDCC研究人员具有明显的优势 从研究过渡到临床试验。