Core C: Cell Processing and Immune Monitoring Core

核心 C：细胞处理和免疫监测核心

• 批准号: 10700028
• 负责人: EVERETT MEYER
• 金额: $ 53.71万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10700028
• 关键词: Blood; Blood specimen; Bone Marrow Transplantation; Cell Therapy; Cells; Clinical; Clinical Trials; Collaborations; Collection; Contracts; Core Facility; Dedications; Development; Documentation; Drug or chemical Tissue Distribution; Ensure; Genomics; Goals; Good Manufacturing Process; Healthcare; Human; Immune; Immunologic Monitoring; Immunology procedure; Infrastructure; Institution; Laboratories; Measurement; Measures; Monitor; Nucleotides; Performance; Pharmacists; Pre-Clinical Model; Preparation; Procedures; Process; Production; Productivity; Program Research Project Grants; Qualifying; Research; Research Contracts; Research Personnel; Residual Neoplasm; Resources; Sampling; Services; Specimen; Standardization; Supporting Cell; T cell receptor repertoire sequencing; T-cell receptor repertoire; Technical Expertise; Techniques; Technology; Therapy Clinical Trials; Tissue Banks; Tissues; Transplantation; Universities; Validation; Vendor; arm; biobank; leukemia/lymphoma; manufacturing cost; molecular pathology; phase 1 study; post-transplant; programs; quality assurance; therapy development

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.

核心C（细胞处理和免疫监测核心）：项目摘要/摘要 细胞处理和免疫监测核心（核心C）将支持本提案中的每个项目， 利用斯坦福大学现有的基础设施，并协助项目调查人员进行标准化的 利用这些资源。核心C在制备细胞制剂方面提供技术专长和监管支持。 用于临床试验的产品，包括产品操作和表征、质量管理和工艺 文献.这项支持将由斯坦福大学卫生保健细胞治疗设施（CTF）提供。通过 抵消开发和制造成本，并为专门的细胞药剂师提供支持，核心 C提供符合现行组织管理规范（cGTP）的基于细胞的治疗方法的处理 良好的生产规范（cGMP）。Core C的一个重要功能是促进交互 通过协助细胞的转化发展， 基于临床前模型的治疗。核心C促进组织库并管理样本分配， investigators.通过协商工作组和斯坦福大学光谱生物库之间的合作安排， C将支持一个基于项目的组织库，包括收集来自供体移植物、细胞产品和 移植前和移植后的血液样本，供项目团队长期储存和使用。核心C提供 T细胞受体库的标准化免疫监测，并促进使用其他专门的免疫 通过现有的机构共享核心设施进行化验。基于我们过去Core C优化的一个平台 为了测量TCR Vb CDR3库，我们将为每个项目提供标准化的TCR测序， 目标是在相同条件下评估供体移植物、实验细胞产物和移植后样品， 每个项目的方式。我们还将协助每个项目访问和使用免疫资源 通过人类免疫监测核心（HIMC）和基因组学服务中心提供监测。在 总之，这个核心有助于将PPG集成到斯坦福大学建立的大型基础设施中， 开展和科学监测细胞疗法临床试验，从而避免不必要的重复 资源和提高效率。