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

IGF::OT::IGF - 细胞疗法生产协助 (PACT) - 细胞加工设施

• 批准号: 9581237
• 负责人: JOSEPH GOLD
• 金额: $ 60.76万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-28 至 2018-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9581237
• 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）细胞疗法。该计划将资助美国六个地理上分散的细胞处理设施（CPFs）和一个协调中心（CC），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，以及在心脏，肺和血液细胞疗法研究领域开发新型细胞疗法所需的行政和监管专业知识。CC将是PACT计划组织和监管方面的监督员和协调员。PACT CPF将作为与细胞治疗相关的转化研究的性能中心和细胞治疗产品的制造商为研究者提供服务。这些中央伙伴关系将根据其满足请求的能力评估服务请求并确定优先次序。PACT CPFs将从NHLBI获得资金，为需要制造支持的学术界和工业界的研究人员制造细胞治疗产品。临床级产品和转化研究的产品申请将被接收、评估，如果获得批准，则分配给CPF进行生产。细胞产品主要用于美国境内的临床使用。CPF仅可根据试验性新药（IND）放行产品用于临床使用。