The aim of this core is to provide state of the art translational research support services for the novel cellular and immune-based therapies described in the projects in this proposal. Specifically, Core C personnel will perform the large scale production of the NK cell, Treg and Tprog products for the clinical trials in a GMP facility. The Core will also be responsible for the comprehensive immune monitoring of patient and product samples to assess the success of the novel experimental therapies described in Project 1 (T regulatory cells, PI: JE Wagner) and Project 3 (NK cells, PI: JS Miller). Core personnel work closely with the research staff from Core A (Administration) and with the biostatistics and data management staff (Core B: Biostatistics) to facilitate collection and tracking of clinical research samples and provide investigators with complete and accurate immune monitoring data which can be integrated with clinical outcome data.
The Specific Aims of Core C are: 1. To perform large-scale production of NK, Treg and Tprog cells products in a GMP facility 2. To monitor the quality of clinical GMP products 3. To perform comprehensive immune monitoring of patient samples 4. To assist with integration of research and clinical outcome data
Core C supports sample collection, GMP cell product processing and immune monitoring for this program. Immune monitoring is critical for the interpretation of the clinical trials and to help trouble-shoot problems. The Core's shared resources are critical to the scientific integrity between projects and this Program.
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