This laboratory is a specialized facility at the University of Pittsburgh Cancer Institute (UPCI), which isdedicated to the state-of-the-art evaluation of immune responses prior to, during and after therapeuticinterventions in patients with cancer. It also generates cellular products for human therapy. In its role asCore for this Program Project, the IMCPL will assume responsibility for supporting the biotherapy-basedclinical trials proposed by all four projects. The Core, functioning as a GMP facility, will culture and characterizedendritic cells (DC) for patient therapy and prepare vaccines by pulsing these DC with peptides or proteins.The Core will be responsible for quality and sterility of the DC-based vaccines. It will also procure and processall body fluids and tissues harvested in the course of the clinical trials associated with this Program Project.The Core will monitor immunologic responses to the administered vaccines by performing ELISPOT assays,tetramer analyses or cytokine flow cytometry (CFC). Cytokines in supernatants or body fluids will bemonitored by the immunobead-based multiplex method. The Core will also be prepared to assist the ProgramProject investigators in implementing assays necessary for evaluation of immunologic responses tovaccines. The Core will ensure that all cellular products it generates and samples it collects areaccompanied by appropriate documentation that will permit linking laboratory analyses with clinical results.The Core will also provide assistsance in preparation of IND submissions. The Core laboratory has a longhistory of collaboration with all of the investigators, and in the context of this Program Project will be entirelydedicated to the support of the clinical trials for patients with head and neck cancer, melanoma or renal cellcarcinoma.
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