The mission of the Cell Therapies Core Facility (CTCF) is to produce the highest quality cellular products in support of novel, investigator-initiated clinical trials, and to facilitate the monitoring of immunologic function in cancer patients undergoing immune- and/or gene-based therapies. Cellular products that are administered to patients with therapeutic intent fall under the definition of Pharmaceuticals. The manufacture of these products is regulated by the Food and Drug Administration under the current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) statutes. The CTCF was designed, both physically and functionally to work within this regulatory framework, thus relieving the individual investigators of concern for this aspect of their research effort. To further facilitate translational research, the CTCF may be engaged throughout the process of developing clinical trials of novel cell therapy products. Specifically, the CTCF provides pre-clinical scale-up engineering for cell therapy products which have been developed in rodent models, and also handles all aspects of Investigative New Drug (IND) applications, from submission through initial approval. In addition the CTCF provides post-therapy immune monitoring performed on protocol in order to aid in the determination of the efficacy of specific cell and/or gene therapy agents in augmenting anti-neoplasia immunologic function. The CTCF occupies approximately 2700 sf containing five class 10,000 cleanrooms, two conventional labs for handling closed system products, a liquid nitrogen cell banking lab, an apheresis lab, and a cGMP/cGTP compliant materials storage area. All technologists are specifically trained in cGMP/cGTP production methods; all production is done under strictly documented processes; and, all activities, including personnel training, acquisition of materials and equipment, and production are scrupulously documented. A quality management plan under the coordination of a specific, independent individual is in place.
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