Biologics Manufacturing Core

用于这种孢子应用的生物制剂制造核心致力于临床试验的生产 材料根据个别项目和所有适用州的规划要求大纲， 针对研究产品的地方和联邦法规。核心分为三个生产组； 细胞产品、单抗和病毒载体。每个小组由一名主管领导，具有广泛的 具有临床试验材料和良好生产规范(GMP)的生产经验。每个人 集团由质量系统团队(质量保证和质量控制)提供支持，以确保 调查性产品制造的测试和文档编制应根据适用的 规章制度。制造将在两个地点进行。生物医学和遗传学中心(CBG)和 细胞医学实验室(LCM)位于新的阿诺德和梅布尔·贝克曼中心 癌症免疫治疗和肿瘤免疫学于2009年完成。单抗和 项目1、3和4的构建体以及项目1的病毒载体将在CBG While细胞中制造 项目1的产品将在LCM中生产。在过去的五年中，单抗 已经为以前的孢子项目1、2、4和5生产了产品，其中一些已经 用于临床试验。广泛开发单抗的制造、接合和瓶装程序 产品已经出现了。建立了一种临床规模单抗偶联的新方法。 已开发并于最近出版。细胞医学实验室(LCM)已经生产了产品 对于孢子项目2(滤泡性淋巴瘤的过继免疫疗法)的前一次迭代，是 目前为套细胞/DLBC淋巴瘤生产产品(项目1)。粗放式加工 在封闭系统细胞处理、细胞选择、慢病毒为基础的 为生产研究用细胞产品做准备的基因修改和扩展 淋巴瘤和其他血液系统恶性肿瘤。已经制造出了质粒DNA和病毒载体 针对滤泡性淋巴瘤和外套细胞/DLBC淋巴瘤方案，目前正在为 为孢子项目1治疗非霍奇金淋巴瘤患者。

The Biologics Manufacturing core for this SPORE application is dedicated to the production of clinical trial materials according to programmatic requirements outlines in the individual projects and all applicable state, local and Federal regulations for investigational products. The core is divided into three production groups; cell products, monoclonal antibodies and viral vectors. Each group is led by a Director with extensive experience in the production of clinical trials materials and Good Manufacturing Practices (GMP). Each group is supported by a Quality Systems Team (Quality Assurance and Quality Control) that ensures that testing and documentation of investigational product manufacturing is performed according to the applicable regulations. Manufacturing will occur at two sites. The Center for Biomedicine and Genetics (CBG) and the Laboratory for Cellular Medicine (LCM) manufacturing facility in the new Arnold and Mabel Beckman Center for Cancer Immunotherapeutics and Tumor Immunology completed in 2009. Monoclonal antibodies and constructs for Projects 1, 3 and 4 and Viral vectors for Project 1 will be manufactured in the CBG while cell products for Project 1 will be manufactured in the LCM. Over the past five years monoclonal antibody products have been produced for the previous SPORE Projects 1,2,4 and 5, some of which have been used in clinical trials. Extensive development of manufacturing, conjugating and vialing procedures for MAb products has taken place. A new method for the conjugation of MAbs at clinical scale quantities has been developed and recently published. The Laboratory for Cellular Medicine (LCM) has manufactured products for the previous iteration of SPORE Project 2 (Adoptive Immunotherapy for Follicular Lymphoma), is currently manufacturing products for Mantle Cell/DLBC Lymphoma (Project 1). Extensive process development has taken place in the areas of closed system cell processing, cell selection, lentiviral-based genetic modification and expansion in preparation for manufacturing investigational cell products for Lymphoma and other hematological malignancies. Plasmid DNA and Viral vectors have been manufactured for Follicular Lymphoma and Mantle Cell/DLBC Lymphoma protocols and are currently being developed for treating NHL patients for SPORE Project 1.