Cell Therapies

细胞疗法

• 批准号: 7516334
• 负责人: William Steven Dalton
• 金额: $ 8.93万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7516334
• 关键词: Area; Blood Component Removal; Cancer Patient; Cell Therapy; Cells; Class; Clinical Trials; Core Facility; Equipment; Gene Therapy Agent; Genes; Human Resources; Immune; Immunologic Monitoring; Immunologics; Immunotherapy; Individual; Liquid substance; Methods; Mission; Neoplasms; Nitrogen; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Process; Production; Protocols documentation; Research; Research Personnel; Rodent Model; System; Therapeutic; Tissues; Training; Translational Research; United States Food and Drug Administration; Work; base; cell bank; cellular engineering; design; falls; novel; pre-clinical; scale up

The mission of the Cell Therapies Core Facility (CTCF) is to produce the highest quality cellular products in support of novel, investigator-initiated clinical trials, and to facilitate the monitoring of immunologic function in cancer patients undergoing immune- and/or gene-based therapies. Cellular products that are administered to patients with therapeutic intent fall under the definition of Pharmaceuticals. The manufacture of these products is regulated by the Food and Drug Administration under the current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) statutes. The CTCF was designed, both physically and functionally to work within this regulatory framework, thus relieving the individual investigators of concern for this aspect of their research effort. To further facilitate translational research, the CTCF may be engaged throughout the process of developing clinical trials of novel cell therapy products. Specifically, the CTCF provides pre-clinical scale-up engineering for cell therapy products which have been developed in rodent models, and also handles all aspects of Investigative New Drug (IND) applications, from submission through initial approval. In addition the CTCF provides post-therapy immune monitoring performed on protocol in order to aid in the determination of the efficacy of specific cell and/or gene therapy agents in augmenting anti-neoplasia immunologic function. The CTCF occupies approximately 2700 sf containing five class 10,000 cleanrooms, two conventional labs for handling closed system products, a liquid nitrogen cell banking lab, an apheresis lab, and a cGMP/cGTP compliant materials storage area. All technologists are specifically trained in cGMP/cGTP production methods; all production is done under strictly documented processes; and, all activities, including personnel training, acquisition of materials and equipment, and production are scrupulously documented. A quality management plan under the coordination of a specific, independent individual is in place.

细胞疗法核心设施（CTCF）的任务是在 支持新型，研究者发射的临床试验，并促进监测免疫功能 接受免疫和/或基因疗法的癌症患者。给药的蜂窝产品 治疗意图的患者属于药物的定义。这些制造 产品受到当前良好制造实践的监管 （CGMP）和当前良好的组织实践（CGTP）法规。 CTCF的设计是在物理上和 在此监管框架内工作，从而使个人调查人员关心 他们研究工作的这一方面。为了进一步促进转化研究，CTCF可能会参与 在开发新型细胞疗法产品的临床试验过程中。具体而言，CTCF 为在啮齿动物中开发的细胞疗法产品提供了临床前的扩大工程 模型，还处理调查性新药（IND）应用的各个方面，从提交到 最初的批准。此外，CTCF提供了在方案中执行的治疗后免疫监测 为了帮助确定特定细胞和/或基因治疗剂增强的功效 抗雷神免疫功能。 CTCF占据了大约2700平方英尺，其中包含五个10,000级洁净室，两个常规实验室 用于处理封闭的系统产品，液氮细胞库实验室，刻度实验室和CGMP/CGTP 合规材料存储区。所有技术人员均经过CGMP/CGTP的专门培训 方法;所有生产均在严格记录的过程中进行；而且，包括人员在内的所有活动 培训，材料和设备的获取以及生产的记录。质量 在特定独立个人的协调下的管理计划已经到位。