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.

细胞治疗核心设施（CTCF）的使命是生产最高质量的细胞产品， 支持新的，免疫启动的临床试验，并促进监测免疫功能， 接受基于免疫和/或基因的治疗的癌症患者。给予的细胞产品 具有治疗意图的患者属于药物的定义。制造这些 产品由美国食品药品监督管理局根据现行药品生产质量管理规范进行监管 （cGMP）和现行组织质量管理规范（cGTP）法规。CTCF的设计，无论是在物理上， 在这一监管框架内工作，从而减轻了个别调查人员的关注， 这方面的研究成果。为了进一步促进转化研究，CTCF可能会参与 在开发新型细胞治疗产品的临床试验的整个过程中。具体而言，CTCF 为已在啮齿动物中开发的细胞治疗产品提供临床前放大工程 模型，并处理研究性新药（IND）申请的所有方面，从提交到 初步批准。此外，CTCF还提供了治疗后免疫监测， 为了帮助确定特定细胞和/或基因治疗剂在增强 抗肿瘤免疫功能。 CTCF占地约2700平方英尺，包含五个10，000级洁净室，两个传统实验室 用于处理封闭系统产品，液氮细胞库实验室，单采实验室和cGMP/cGTP 合规材料储存区。所有技术人员均接受过cGMP/cGTP生产方面的专门培训 方法;所有生产都是在严格的文件化流程下进行的;所有活动，包括人员 培训、材料和设备的采购以及生产都严格记录在案。质量 在一个具体的、独立的个人的协调下，管理计划已经到位。