) The Cellular Products Laboratory is a new shared facility in this CCSG renewal application. It is dedicated to generation and preparation of quality products for cellular and gene therapy of cancer and of tumor vaccines. This laboratory that previously was a component of the Immunologic Monitoring Laboratory, has assumed an increasingly important role in supporting the conduct of novel immunotherapy trials at the UPCI. It performs over 10,000 procedures annually, most in support of the Biological Therapeutics Program, but also for the Head and Neck Program. Its responsibilities include cell culture of hematopoietic or non-hematopoietic cells, vaccine preparation, genetic modification of human cells, tissue procurement, processing and distribution for clinical trials, sterility and safety evaluation of each product prior to its administration to patients, and development of new products and procedures for use in future clinical protocols. It is operated according to FDA criteria for good laboratory practice (GLP). The Laboratory has established an excellent record of accomplishments and its unique expertise has enabled rapid translation of novel technologies to clinical trials. The Laboratory has established a fee-for-service price schedule. In FY1998, it s services were utilized by 30 clinical research protocols.
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