The mission of the Cell Therapies Core Facility (CTCF) is to produce the highest quality cellular products insupport of novel, investigator-initiated clinical trials, and to facilitate the monitoring of immunologic function incancer patients undergoing immune- and/or gene-based therapies. Cellular products that are administered topatients with therapeutic intent fall under the definition of Pharmaceuticals. The manufacture of theseproducts 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 andfunctionally to work within this regulatory framework, thus relieving the individual investigators of concern forthis aspect of their research effort. To further facilitate translational research, the CTCF may be engagedthroughout the process of developing clinical trials of novel cell therapy products. Specifically, the CTCFprovides pre-clinical scale-up engineering for cell therapy products which have been developed in rodentmodels, and also handles all aspects of Investigative New Drug (IND) applications, from submission throughinitial approval. In addition the CTCF provides post-therapy immune monitoring performed on protocol inorder to aid in the determination of the efficacy of specific cell and/or gene therapy agents in augmentinganti-neoplasia immunologic function.The CTCF occupies approximately 2700 sf containing five class 10,000 cleanrooms, two conventional labsfor handling closed system products, a liquid nitrogen cell banking lab, an apheresis lab, and a cGMP/cGTPcompliant materials storage area. All technologists are specifically trained in cGMP/cGTP productionmethods; all production is done under strictly documented processes; and, all activities, including personneltraining, acquisition of materials and equipment, and production are scrupulously documented. A qualitymanagement plan under the coordination of a specific, independent individual is in place.
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