IMMUNOLOGICAL MONITORING AND CELLULAR PRODUCTS LABORATORY

免疫监测和细胞产品实验室(IMCPL)是UPCI共享的设施 负责治疗细胞产物的生成(CPL)和免疫功能的连续监测 在接受生物疗法(IML)治疗的癌症患者中。IMCPL一直在扮演一名 在支持新的研究人员发起的免疫疗法试验中的重要作用。它75%的使用是 与癌症有关。CPL为肿瘤疫苗和癌症的细胞和基因治疗提供优质产品 使用当前良好的制造规范和良好的组织规范(cGMP/CGTP)条件。2008年， IMCPL的CPL部门为临床或研究方案提供服务，执行11,793个程序， 从大规模的治疗产品到用于临床前研究的较小的培养，其复杂性各不相同 试验新的细胞产品，并帮助制备研究用新药(IND)。IML使 向用户提供一系列最先进的免疫监测分析，在 严格的质量控制程序。年共进行了54,588项临床或研究测试 2008年。这些包括免疫细胞表型、单细胞分析(ELISPOT、四聚体分析和 细胞因子流式细胞术)用于疫苗监测，以及通过Flow进行基于群体的细胞增殖分析 细胞计数(CFSE)、Luminex细胞因子分析、细胞毒性、细胞凋亡和T细胞信号转导。IMCPL 维护为新产品/化验开发、评估而设计的研发计划 和标准化。向用户提供有关电池产品/测试选择和结果解释的建议也是一部分 关于IMCPL的责任。IMCPL拥有独立监控和广泛的质量控制(QC) 和质量保证(QA)计划，以确保测试结果的有效性和治疗的安全性/质量 产品。IMCPL制定了按服务收费的时间表，并给予优先和折扣费用 给UPCI族成员。高质量的细胞产品和由 UPCI项目的IMPCL有助于临床和研究研究的整体卓越。

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.