Cell Processing and Sample Distribution Laboratory

项目总结(见说明)： CORE D通过斯坦福细胞治疗和移植(SCTT)实验室运营，将为项目1-5的具体责任1下的临床试验提供符合cGMP的细胞处理和质量管理。这些包括：1)从动员的异基因供者外周血中高纯度地分选自然产生的调节性T细胞，其表型定义为CD4+/CD25+/CD1271ow/FoxP3+ 从同种异基因供者外周血中分离CD8+CD45RA记忆T细胞；4)从异基因供者外周血细胞中培养细胞因子诱导的杀伤(CIK)细胞；5)从半相合供者外周血中分离不含成熟T细胞的共同淋巴祖细胞(CLP)CD34+CD127+LIN-细胞；6)产品储存、产品管理 发布用于分发的测试、过程文档和法规遵从性监督，以支持在INDS项目下管理的试验。核心D还将为这些项目提供细胞处理程序和材料的验证，以及准备用于立即分析的初级人体组织样本 以及来自异基因供受者对的外周血液样本的组织库。 SCTT实验室位于斯坦福医院内，包括超过2,000平方英尺的100,000(ISO 8)级无尘室，其中包括四个细胞处理室，每个处理室都配备了用于细胞处理的标准设备；一个冷冻保存室，配有受控速率的LN2冷冻机和存储单元；以及产品质量控制测试和检疫区域。用于高级细胞操作的仪器包括三种二氧化碳 其中包括两台用于细胞培养的孵化器、两台用于免疫磁性细胞选择的CliniMACS设备(Miltenyi Biotec，德国Bergish-Gladbach)，以及一台适用于临床分级细胞分选的流入细胞分选机(Becton Dickinson Biosciences，加利福尼亚州圣何塞)。位于该设施中的第二台分选机被配置用于细胞分类和分析，以支持项目1-6和核心C的开发和研究目标。

PROJECT SUMMARY (See instructions): Core D, operating through the Stanford Cellular Therapeutics & Transplantation (SCTT) Laboratory will provide cGMP-compliant cell processing and quality management for clinical trials under Specific Responsibility 1 for Projects 1-5. These include: 1) high purity sorting of naturally occurring regulatory T cells phenotypically defined as CD4+/CD25+/CD1271ow/FoxP3+ from allogeneic donor mobilized peripheral blood cells; 2) preparation of Mantle Cell Lymphoma cellular vaccines derived from autologous tumor cells; 3) high purity selection of CD8+CD45RA- memory T cells from allogeneic donor peripheral blood apheresis collections; 4) culturing Cytokine Induced Killer (CIK) cells from allogeneic donor peripheral blood cells; 5) isolation of Common Lymphoid Progenitor (CLP) CD34+CD127+Lin- cells free of mature T cells from haploidentical donor peripheral blood apheresis collections; 6) Management of product storage, product release testing for distribution, process documentation, and regulatory compliance oversight in support of the trials managed under the INDs project. Core D will also provide validation of cell processing procedures and materials for these projects as well as preparation of primary human tissue samples for immediate analysis and tissue banking of peripheral blood samples from allogeneic donor-recipient pairs. The SCTT Laboratory is located within Stanford Hospital and includes more than 2,000 square feet of class 100,000 (ISO 8) clean room space with four cell processing rooms each equipped with standard devices for cell processing; a cryopreservation room with controlled rate LN2 freezers and storage units; and areas for product QC testing and quarantine. Instrumentation for advanced cell manipulations includes three C02 incubators for cell culturing, two CliniMACS devices (Miltenyi Biotec, Bergish-Gladbach, Germany) for immunomagnetic cell selection, and an Influx Cell Sorter (Becton Dickinson Biosciences, San Jose, CA) adapted to clinical grade cell sorting. A second sorter located in the facility is configured for cell sorting and analysis to support the development and research goals of Projects 1-6 and Core C.