IGF::OT::IGF Production Assistance for Cellular Therapies (PACT)- Cell Processing Facilities

IGF::OT::IGF 细胞疗法生产援助 (PACT) - 细胞加工设施

• 批准号: 9521689
• 负责人: MICHAEL SHAW
• 金额: $ 17.33万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9521689
• 关键词: Academia; Adverse event; Alpha Cell; Animal Welfare; Antibodies; Archives; Area; Biocompatible Materials; Biological; Blood; Cell Therapy; Cells; Center for Translational Science Activities; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Consult; Contractor; Contracts; Data; Databases; Development; Educational Activities; Educational workshop; Ensure; Evaluation; Event; Funding; Geography; Heart; Industry; Infusion procedures; Institution; Institutional Review Boards; Investigational Drugs; Laboratories; Laboratory Animals; Lung; Maintenance; Manuals; Manufacturer Name; Manuscripts; Monitor; National Heart, Lung, and Blood Institute; Office for Human Research Protections; Performance; Phase; Procedures; Process; Production; Professional Organizations; Protocols documentation; Publications; Quality Control; Reagent; Recombinant Proteins; Regulation; Reporting; Research Design; Research Personnel; Sampling; Services; Ships; Site Visit; Testing; Therapeutic Studies; TimeLine; Training; Translational Research; United States National Institutes of Health; Work; Writing; authority; base; cytokine; design; interest; manufacturing facility; material transfer agreement; member; novel; operation; preclinical study; programs; quality assurance; translational study

The Production Assistance for Cellular Therapies (PACT) program produces and tests novel somatic (biological) cell therapies. This program will fund up to six geographically dispersed Cell Processing Facilities (CPFs) and one Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study and early phase clinical trial study design, and administrative and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung and blood cellular therapy research. The CC will be the monitor and coordinator for organizational and regulatory aspects of the PACT Program. The PACT CPFs will be established to serve investigators as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. These CPFs will evaluate and prioritize requests for service based on their ability to fulfill the request. PACT CPFs will receive funding from the NHLBI to manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. Product requests for clinical grade products and translational research will be received, evaluated, and, if approved, assigned to a CPF for manufacture. The cellular products are primarily intended for clinical use within the U.S. Products may be released by the CPF for clinical use only under an Investigational New Drug (IND).

细胞疗法生产援助(PACT)计划生产和测试新的体细胞(生物)疗法。该计划将为美国最多六个地理上分散的细胞处理设施(CPFS)和一个协调中心(CC)提供资金，这些中心有能力提供咨询、制造、临床前研究和早期临床试验研究设计，以及在心、肺和血液细胞治疗研究领域开发新型细胞疗法所需的行政和监管专业知识。协调委员会将对PACT方案的组织和监管方面进行监测和协调。Pact CPfS将作为与细胞治疗相关的翻译研究和细胞治疗产品制造商的绩效中心，为研究人员服务。这些CPF将根据其满足请求的能力来评估服务请求并确定其优先级。PACT CPfS将从NHLBI获得资金，为需要制造支持的学术界和行业的研究人员制造细胞治疗产品。临床级产品和转化性研究的产品请求将被接收、评估，如果获得批准，将分配给CPF进行生产。蜂窝产品主要用于美国境内的临床使用。CPF只能根据研究新药(IND)发布临床使用的产品。