Core--cGMP cell processing

CGMP信元处理设施是本次授权续签申请中的新共享资源。它目前正在进行调试，将于2002年春季开放。它已经被设计并 由Hutchinson根据FDA内概述的原则构建，以考虑人类细胞治疗和当前良好的组织制造实践。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复生产人类造血细胞或免疫功能细胞。该设施占地4500平方米。包括4个大型cGMP生产套件，一个单独的QA/QC实验室，以及用于清洁准备、介质准备和冷藏的额外区域。生产活动将使用书面的、经批准的程序进行，由经过专门培训和合格的人员执行。该设施将定期进行清洁，以最大限度地减少生物污染，所有设备将按规定的时间表进行维护和校准，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的研究人员，他们的临床研究需要更复杂类型的细胞处理，如体外培养、基因修改和/或干细胞、树突状细胞和T细胞的激活。这些成分将被用作该联盟针对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的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.