Cell Processing and Sample Distribution Laboratory

项目总结（见说明）： 核心D通过斯坦福大学细胞治疗与移植（SCTT）实验室运营，将根据项目1-5的具体职责1为临床试验提供符合cGMP的细胞处理和质量管理。其中包括：1）从同种异体供体动员的外周血中高纯度分选表型上定义为CD 4 +/CD 25 +/CD 127 +/FoxP 3+的天然存在的调节性T细胞 单元格; 2）制备衍生自自体肿瘤细胞的套细胞淋巴瘤细胞疫苗; 3）从同种异体供体外周血单采术收集物中高纯度选择CD 8 + CD 45 RA-记忆T细胞; 4）从同种异体供体外周血细胞中培养细胞因子诱导的杀伤（CIK）细胞; 5）从单倍体相合供体外周血单采术收集物中分离不含成熟T细胞的共同类血友病祖细胞（CLP）CD 34 + CD 127 +Lin-细胞; 用于分销、过程记录和监管合规性监督的放行检测，以支持IND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，以及用于即时分析的原代人体组织样本的制备 以及来自同种异体供体-受体对的外周血样品的组织库。 SCTT实验室位于斯坦福大学医院内，包括超过2，000平方英尺的100，000级（ISO 8）洁净室空间，其中有四个细胞处理室，每个细胞处理室都配备有用于细胞处理的标准设备;一个冷冻保存室，配有受控速率的液氮冷冻机和储存装置;以及产品QC测试和检疫区。用于先进细胞操作的仪器包括三个CO2 用于细胞培养的培养箱、用于免疫磁性细胞选择的两个CliniMACS装置（Miltenyi Biotec，Bergish-Gladbach，德国）和适于临床级细胞分选的流入细胞分选仪（Becton Dickinson Biosciences，圣何塞，CA）。位于设施中的第二个分选机被配置用于细胞分选和分析，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.