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.
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