Core--cGMP cell processing

cGMP细胞处理设施是本次资助更新申请中的一项新的共享资源。该中心目前正在试运行，将于2002年春季启用。它被设计和 由哈钦森根据FDA的人类细胞治疗考虑要点和现行组织生产质量管理规范中概述的原则构建。该设施将允许在治疗研究所需的严格质量控制和安全条件下可重现地生产人类造血或免疫活性细胞。该设施包括4500平方米。英尺，包括4个大型cGMP生产车间、一个独立的QA/QC实验室以及用于清洁分段、培养基制备和冷藏的额外区域。生产活动将由经过专门培训的合格人员按照书面批准程序进行。该设施将定期进行清洁以最大限度地减少生物负载，所有设备将按照规定的时间表进行维护和校准，并且每项活动都将根据cGMP法规和指南进行记录。cGMP设施将用于支持Consortium的研究者，其临床研究需要更复杂类型的细胞处理，如离体培养、遗传修饰和/或干细胞、树突状细胞和T细胞的活化。这些成分将作为该联盟遗传和传染病以及乳腺癌、白血病、淋巴瘤、骨髓瘤和黑色素瘤等恶性肿瘤整体治疗计划的一部分。

The cGMP Cell Processing Facility is a new Shared Resource in this grant renewal application. It is currently undergoing commissioning and will open in spring 2002. It has been designed and constructed by the Hutchinson in accordance with the principles outlined within the FDA's Points to Consider for Human Cellular Therapy and current Good Tissue Manufacturing Practices. The Facility will allow for the reproducible production of human hematopoietic or immuno-competent cells under the stringent quality control and safety conditions that are required for therapeutic studies. The Facility consists of 4500 sq. ft., comprising 4 large cGMP production suites, a separate QA/QC laboratory, and additional areas for clean staging, media preparation, and cold storage. Production activities will be conducted using written, approved procedures performed by specifically trained and qualified personnel. The Facility will be cleaned on a regular basis to minimize bioburden, all equipment will be maintained and calibrated on defined schedules, and every activity will be documented in accordance with cGMP regulations and guidelines. The cGMP Facility will be utilized to support Consortium's investigators whose clinical research studies require more complicated types of cell processing such as ex-vivo culturing, genetic modification, and/or activation of stem cells, dendritic cells, and T-cells. These components will be used as part of the Consortium's overall treatment program for genetic and infectious diseases, as well as malignancies such as breast cancer, leukemia, lymphoma, myeloma and melanoma.