The Vaccine and Cell Therapy Core Laboratory is a new shared resource at the NYU Cancer Institute that is an essential part of the recently established 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. It does this by providing two types of services. 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 GMP 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 Core 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. The Vaccine and Cell Therapy Core opened.in early 2006, and currently supports three immunotherapy trials for cancer at NYU and two HIV vaccine trials at Massachusetts General Hospital. A fourth cancer immunotherapy trial at NYU is planned for the fourth quarter of 2006. We anticipate an expanding user base over the next few years as the Tumor Vaccine Program continues to grow, and as an increasing number of investigators begin to take advantage of this remarkable resource.
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