Core C: Cell Processing and Immune Monitoring Core

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Core C (Cell Processing and Immune Monitoring Core): Project Summary/Abstract The Cell Processing and Immune Monitoring Core (Core C) will support each of the projects in this proposal by leveraging existing infrastructure at Stanford University and assisting project investigators in the standardized use of these resources. Core C provides technical expertise and regulatory support in the preparation of cellular products for clinical trials including product manipulation and characterization, quality management, and process documentation. This support will be provided by the Stanford Health Care Cellular Therapy Facility (CTF). By offsetting development and manufacturing costs, and providing support to a dedicated cellular pharmacist, Core C provides processing for cell-based therapeutics compliant with both current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP). An important function of Core C is to facilitate interaction between the clinical and research arms of the program by assisting with the translational development of cell- based therapies from pre-clinical models. Core C facilitates tissue banking and manages sample distribution to investigators. Through a collaborative arrangement between the CTF and the Stanford Spectrum Biobank, Core C will support a project-based tissue bank including collection of material from donor grafts, cell products and pre- and post-transplant blood specimens for long term storage and use by project teams. Core C provides standardized immune monitoring of the T cell receptor repertoire and facilitates use of other specialized immune assays through existing institutional shared core facilities. Building on our past Core C optimization of a platform for measuring TCR Vb CDR3 repertoire, we will provide standardized TCR sequencing to each project, with a goal of having the donor graft, experimental cell product, and post-transplant samples evaluated in the same manner for each project. We will also assist each project in accessing and using the resources for immune monitoring available through the Human Immune Monitoring Core (HIMC) and genomics service centers. In summary, this Core serves to help integrate the PPG into the large infrastructure established at Stanford for conducting and scientifically monitoring cellular therapy clinical trials, thus avoiding the unnecessary duplication of resources and enhancing efficiency.