The four projects comprising this application ultimately involve the use of immune cells to treat lymphoma. Food and Drug Administration (FDA) regulations require that therapeutic cell populations must be manufactured under current Good Manufacturing Practices (cGMP). Core C (Cell and Vector Production) will provide the infrastructure necessary to meet this requirement. The cGMP facility at the Center for Cell and Gene Therapy consists of 22 ISO 7 clean rooms fully equipped for the preparation of cell and gene therapy products. For nearly 20 years the staff have manufactured more than 7,000 cellular therapy final products (and countless intermediates), and >60 clinical grade viral vectors and master and working cell banks in support of more than 60 IND studies and international clinical protocols. During this period, the facility was designated as a National Gene Vector Laboratory and as a National Somatic Cell Processing Facility under a contract from NHLBI Production Assistance for Cellular Therapy (PACT) program. Manufacturing services are supported by a dedicated specialized flow cytometry laboratory, which performs >13,000 test annually, a quality control (QC) laboratory performing in-house testing and environmental monitoring (>25,000 tests/year), and an independent quality assurance (QA) group, which oversees compliance and provides contract QA services to the NHLBI Cardiovascular Cell Therapy Research Network (CCTRN). The program is accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), the College of American Pathologists (CAP), and under the Clinical Laboratory Improvements Amendments (CLIA). The Cell and Vector Production facility is registered with the FDA and the US Department of Agriculture. In addition to manufacturing responsibilities, the Core staff are experienced in transitioning research processes into GMP-compliant procedures and providing regulatory advice. This experience will be essential in supporting the clinical components of this Lymphoma SPORE application.
The Cell and Vector Production Core (Core C) is essential for the clinical studies proposed in each of the SPORE projects. The Core will be responsible for the preparation of therapeutic grade viral vectors and for manufacturing the various cellular therapy products that will be used. The facility will also assist in the translation of preclinical research procedures into clinical scale operations. In addition, Core C will provide the required analytical and quality control and assurance services to ensure compliance with cGMP regulations.
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