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. These services are provided at Baylor through the Cell Processing and Vector Production shared resource. This facility currently supports more than 20 IND cell and gene therapy studies, and is the only facility in the country to be designated as both a National Gene Vector Laboratory and a National Somatic Cell Therapy Laboratory. It produces nearly 1000 cellular therapy products and intermediates, and approximately 20 clinical grade vectors and cell banks annually. The associated Quality Control Laboratory tests and processes more than 12,000 samples annually. The Shared Resource has developed systems to ensure GMP/GTP compliance on an ongoing basis and has been successfully audited on multiple occasions by the FDA and accrediting organizations. 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. In 2009 the shared resource will move to a new state of the art facility comprising 23 clean room suites with all of the associated quality control, quality assurance, flow cytometry and materials management infrastructure. This will provide investigators with unparalleled resources. We believe that a shared resource of this type is an essential component of a modern Cancer Center.
The goal of this Shared Resource is to establish and follow uncompromising, scientifically sound standard conditions for production of cellular therapy products and vectors used in Phase I/II clinical trials.
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