PACT

美国国家心脏、肺和血液研究所(NHLBI)正计划对细胞疗法生产援助(PACT)计划进行竞争性更新，以生产和测试新型体细胞(生物)细胞疗法。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产品中的临床使用

The National Heart, Lung, and Blood Institute (NHLBI) is planning a competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the production and testing of 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