VACCINE AND CELL THERAPY CORE LABORATORY

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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.