Therapeutic Cell Production Shared Resource

治疗细胞生产共享资源（TCP）的使命是为罗斯韦尔公园提供 综合癌症中心CCSG会员可使用最先进的细胞生产设施、设备 和监管知识，以促进开发，并执行I期和II期临床细胞治疗 审判TCP拥有必要的科学、技术和监管专业知识以及运营效率， 基于细胞的免疫疗法，以实施I期和II期临床试验。2010年，罗斯威尔公园投资了 我们的第一个600平方米的工厂英尺cGMP设施。随着需求的增加， 机构投资用于扩大这一足迹，以满足CCSG预期的临床试验需求 成员此外，在2014年，TCP收到CCSG发展基金，以支持成员使用 设施和服务。TCP目前是一个2，552平方米。英尺符合FDA标准的cGMP设施，具有四个10，000级 （ISO7）洁净室，能够同时进行多产品和多工艺制造。我们提供 工艺开发、监管支持和符合cGMP的临床级生产，几乎任何类型 351生物制品，如树突状细胞和工程化T细胞产品。TCP已经建立了一个有组织的， 标准操作程序（SOP）驱动的项目管理方法，包括新项目 可行性评价，项目立项，过程评价，项目竣工评价，项目商务 收尾和客户反馈评估。在过去的五（5）年中，TCP已经为6个罗斯韦尔用户提供服务， 他们都是CCSG成员。作为唯一通过ISO9001认证的细胞治疗制造洁净室设施 在西纽约地区，TCP对于为患者带来创新的细胞免疫疗法至关重要 在我们的集水区更快。TCP的具体目标是：1）制造351型细胞疗法 支持I期和II期IND的临床试验产品。TCP生产符合cGMP的蜂窝 治疗产品，例如树突状细胞和工程化T细胞用于临床试验，以支持I期和II期IND。 已在机构cGMP病毒载体和开发中生产的慢病毒或逆转录病毒载体 这些设备被用于培养患者的T细胞。产品采用新鲜输注或采用GMP冷冻保存合规的流程和程序。2)为扩大或扩大细胞治疗提供咨询服务 产品和符合FDA法规的监管专业知识。TCP协助调查人员在 制定方案，包括确定临床级材料的来源，以便翻译实验室 将研究结果转化为临床试验，并保持严格的质量计划。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， 过程和程序，并最终降低成本。

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.