Renewed interest in cellular and gene therapies has resulted in an increased demand to prepare products for Phase 1 and 2 clinical studies. The Food and Drug Administration has ruled that these materials must be manufactured under current Good Tissue Practice [GTP] or Good Manufacturing Practice [GMP] regulations. In addition, these products are subject to rigorous quality control testing prior to release for use. The development and maintenance of such a manufacturing and testing infrastructure is both expensive and labor intensive. As a result, the provision of these services through a core laboratory makes sense from both an economic and an organizational perspective. The proposed Cell Processing and Vector Production Resource, consisting of two GMP facilities and a Quality Control Laboratory, has the capability to manufacture a wide variety of cellular therapy products, as well as adenoviral and retroviral vectors. Led by Dr. Adrian Gee with an experienced staff, this Resource currently supports more than 20 IND studies, and is the only facility to be designated as both a National Gene Vector Laboratory and a National Somatic Cell Therapy Laboratory. The Resource has developed systems to ensure GMP/GTP compliance on an ongoing basis and has been successfully audited on multiple occasions by the FDA. It is estimated that this facility can offer both manufacturing and testing services at one-quarter to one-tenth the cost of using commercial contract organizations. We believe that a core of this type is an essential component of a modern Cancer Center.
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