VACCINE AND CELL THERAPY CORE LABORATORY

项目总结（见说明）; 疫苗和细胞治疗核心实验室是纽约大学癌症研究所（NYUCI）的高度专业化共享资源，是肿瘤疫苗计划的重要组成部分。该实验室的目的是支持在纽约大学医学中心和合作机构进行的癌症和慢性病毒感染（如艾滋病毒/艾滋病）的实验性免疫疗法的临床试验。实验室提供两种类型的服务，以满足这一目的。首先，实验室按照美国食品药品监督管理局（FDA）要求的现行药品生产质量管理规范（cGMP）规定，在专用的受控空间内制备疫苗和细胞免疫疗法。该cGMP实验室设有三个10，000级（ISO 7）洁净室，其设计具有灵活性，可以生产几乎任何类型的使用操纵人体细胞的治疗。它是大纽约大都市地区为数不多的几个这样的实验室之一。其次，该实验室还设有一个设备齐全的免疫学实验室，提供各种先进的免疫监测技术和服务，以测量患者对疫苗接种的反应。进入该设施使纽约大学的研究人员能够进行研究者发起的研究，并参加药物赞助的研究，从而为临床癌症中心的患者提供在许多疾病环境中获得新疗法的机会。自2006年初开放以来，该设施已支持纽约大学20项已完成和正在进行的癌症免疫治疗试验，马萨诸塞州总医院的2项艾滋病毒疫苗试验，以及默克公司的免疫监测合同。随着越来越多的研究人员利用这一非凡的资源，实验室的用户群不断扩大。

PROJECT SUMMARY (See instructions); The Vaccine and Cell Therapy Core Laboratory is a highly specialized shared resource at the NYU Cancer Institute (NYUCI) that is an essential part of the Tumor Vaccine Program. The purpose of the laboratory is to support clinical trials of experimental immunotherapies for cancer and chronic viral infections such as HIV/AIDS at NYU Medical Center and at collaborating institutions. The laboratory provides two types of services to meet this purpose. First, the laboratory prepares vaccines and cellular immunotherapies in a dedicated, controlled space in accordance with current Good Manufacturing Practice (cGMP) regulations as required by the US Food and Drug Administration (FDA). This cGMP laboratory features three class 10,000 (ISO 7) cleanrooms, and has been designed with the flexibility to manufacture virtually any type of therapy that uses manipulated human cells. It is one of only a handful of such laboratories in the Greater New York metropolitan region. Second, the laboratory also features a very well equipped Immunology Laboratory that offers a variety of sophisticated immune monitoring technologies and services to measure patients' responses to vaccination. Access to this facility has enabled investigators at NYU to undertake investigator initiated studies as well as take part in pharmaceutical-sponsored studies, thus providing patients at the Clinical Cancer Center access to novel therapies in a number of disease settings. Since opening in early 2006, the facility has supported 20 completed and ongoing immunotherapy trials for cancer at NYU, 2 HIV vaccine trials at Massachusetts General Hospital, and immune monitoring contracted by Merck. The user base for the laboratory continues to expand as more investigators take advantage of this remarkable resource.