IMMUNOLOGICAL MONITORING AND CELLULAR PRODUCTS LABORATORY

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The Immunologic Monitoring and Cellular Products Laboratory (IMCPL) is the UPCI shared facility responsible for therapeutic cell product generation (CPL) and for serial monitoring of immunologic functions in patients with cancer who are treated with biologic therapies (IML). The IMCPL has been playing an important role in supporting novel investigator-initiated immunotherapy trials at the UPCI. 75% of its usage is cancer-related. CPL makes quality products for tumor vaccines and for cellular and gene therapy of cancer using Current Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP) conditions. In 2008, the CPL component of IMCPL provided services to clinical or research protocols, performing 11,793 procedures, which varied in complexity from large-scale therapeutic products and smaller cultures for pre-clinical studies to piloting new cell products and help in the preparation of investigational New Drugs (INDs). The IML makes available to users a broad range of state-of-the-art immunologic monitoring assays performed under a rigorous quality control program. A total of 54,588 tests were performed for clinical or research studies in 2008. These included phenotyping of immune cells, single-cell assays (ELISPOT, tetramer analysis and cytokine flow cytometry) for vaccine monitoring, and population-based assays for cell proliferation by flow cytometry (CFSE), cytokine profiling by Luminex, cytotoxicity, apoptosis, and T-cell signaling. The IMCPL maintains a Research and Development program designed for new product/assay development, evaluation and standardization. Advice to users about cell product/test selection and result interpretations are also a part ofthe IMCPL responsibilities. The IMCPL has an independently-monitored and extensive quality control (QC) and quality assurance (QA) program to ensure the validity of test results and safety/quality of therapeutic products. The IMCPL has established a fee-for-service schedule and gives priority as well as discounted fees to the UPCI members. High quality of cellular products and reproducibility of the assays performed by the IMPCL for the UPCI programs contribute to the overall excellence of clinical and research studies.