Therapeutic Cell Production Shared Resource

治疗细胞生产共享资源

• 批准号: 10641719
• 负责人: Pawel Kalinski
• 金额: $ 7.68万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-16 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10641719
• 关键词: Automation; Biological; Businesses; Calendar; Cancer Center Support Grant; Catchment Area; Cell Therapy; Cells; Cellular immunotherapy; Certification; Client; Clinic; Clinical; Clinical Trials; Complex; Comprehensive Cancer Center; Consultations; Cryopreservation; Cyclic GMP; Dendritic Cells; Development; Dose; Ensure; Equipment; Evaluation; Evolution; Faculty; Feedback; Fractionation; Funding; Future; Grant; Immune; Infrastructure; Institution; Investments; Knowledge; Laboratory Finding; Lentivirus Vector; Maintenance; Methodology; Mission; New York; Patients; Peer Review; Phase; Procedures; Process; Process Assessment; Production; Quality Control; Regulation; Research; Research Personnel; Resource Sharing; Resources; Respondent; Retroviral Vector; Running; Services; Source; Surveys; System; T-Lymphocyte; Testing; Therapeutic; Therapy trial; Time; Translating; Viral Vector; cancer immunotherapy; clinical efficacy; cost; engineered T cells; injection/infusion; innovation; manufacture; manufacturing facility; manufacturing process; member; novel therapeutics; operation; pre-clinical; programs; protocol development; quality assurance; recruit; satisfaction; scale up; sound; square foot; virtual

The mission of the Therapeutic Cell Production Shared Resource (TCP) is to provide Roswell Park Comprehensive Cancer Center CCSG members access to state-of-the-art cell production facility, equipment and regulatory knowledge to facilitate the development, and execution of Phase I and II clinical cell therapy trials. The TCP has the requisite scientific, technical and regulatory expertise and operational efficiencies in cell-based immunotherapies, to implement Phase I and II clinical trials. In 2010, Roswell Park invested significant resources to create our first 600 sq. ft. cGMP facility. With increasing demand, a significant institutional investment was made to expand this footprint to meet expected clinical trials needs of CCSG members. In addition, in 2014, the TCP received CCSG Developmental Funds to support member’s use of the facility and services. The TCP is currently a 2,552 sq. ft. FDA compliant cGMP facility with four class 10,000 (ISO7) clean rooms, capable of both simultaneous multi-product and multi-process manufacturing. We provide process development, regulatory support, and cGMP-compliant clinical-grade production of virtually any type 351 biologic, such as dendritic cells and engineered T cell products. The TCP has developed an organized, Standard Operating Procedures (SOP) - driven approach to management of projects, that includes new project feasibility evaluation, project initiation, in-process assessment, completed project assessment, project business close-out and client feedback assessment. During the past five (5) years, the TCP has served 6 Roswell users, all of whom were CCSG members. As the only ISO9001 certified cell therapy manufacturing cleanroom facility in the Western New York region, the TCP is critical to bringing innovative cellular immunotherapies to patients in our catchment area faster. The Specific Aims of the TCP are: 1) To manufacture type 351 cellular therapy products for clinical trials in support of Phase I and II INDs. The TCP manufactures cGMP compliant cellular therapy products, eg. dendritic cells and engineered T cells for clinical trials to support Phase I and II INDs. Lentivirus or retrovirus vectors that have been produced at the institutional cGMP viral vector and development facility are used to transduce patient’s T cells. The products are infused fresh or cryopreserved using GMPcompliant processes and procedures. 2) To provide consultation services for scaling up or out cellular therapy products, and regulatory expertise in compliance with FDA regulations. The TCP assists investigators during protocol development, including identification of sources for clinical-grade materials for translating laboratory findings into clinical trials, and maintains a rigorous Quality program. TCP is responsible for the creation, maintenance, and implementation of a Quality Management System (QMS) for facility operations. Our future plan is to increase the number of CCSG members utilizing the TCP even further by optimizing several new processes and procedures and ultimately reducing cost.

治疗细胞生产共享资源(TCP)的使命是为罗斯威尔公园提供 综合癌症中心CCSG成员获得最先进的细胞生产设施和设备 和法规知识，以促进I期和II期临床细胞疗法的开发和实施 审判。该委员会拥有必要的科学、技术和监管专门知识以及在以下方面的运作效率 以细胞为基础的免疫疗法，实施I期和II期临床试验。2010年，罗斯威尔公园投资了 大量资源来创造我们的第一个600平方英尺。英国《金融时报》CGMP设施。随着需求的增加，一个重要的 进行了机构投资以扩大这一足迹，以满足CCSG预期的临床试验需求 会员。此外，在2014年，该委员会获得了CCSG发展基金，以支持成员使用 设施和服务。Tcp目前的面积为2552平方英尺。英国《金融时报》符合FDA标准的cGMP设施，具有四个级别10,000 (ISO7)洁净室，可同时生产多种产品和多道工序。我们提供 几乎任何类型的流程开发、监管支持和符合cGMP的临床级别生产 351生物，如树突状细胞和工程T细胞产品。TCP已经开发出一种有组织的、 标准操作程序(SOP)驱动的项目管理方法，包括新项目 可行性评估、项目启动、过程评估、已完成项目评估、项目业务 收尾和客户反馈评估。在过去的五(5)年中，TCP为6名罗斯韦尔用户提供了服务， 他们都是CCSG成员。作为唯一通过ISO9001认证的细胞疗法生产洁净室设施 在纽约西部地区，TCP对于为患者带来创新的细胞免疫疗法至关重要 在我们的集水区速度更快。该技术的具体目标是：1)制造351细胞疗法 支持I期和II期IND的临床试验产品。Tcp制造符合cGMP的蜂窝 治疗产品，例如。用于临床试验的树突状细胞和工程T细胞，以支持I期和II期IND。 慢病毒或逆转录病毒载体已在机构生产的cGMP病毒载体和开发 设备被用来转导患者的T细胞。这些产品采用符合GMP的工艺和程序新鲜注入或冷冻保存。2)为扩大或扩大细胞治疗提供咨询服务 产品，以及符合FDA法规的监管专业知识。赔偿委员会在调查期间协助调查人员 制定方案，包括确定临床级实验室翻译材料的来源 将研究结果纳入临床试验，并保持严格的质量计划。由tcp负责创建， 维护和实施设施运营的质量管理体系(QMS)。我们的未来 计划是通过优化几个新的 流程和程序，并最终降低成本。