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Cell Journal، جلد ۱۶، شماره Suppl ۱، صفحات ۱۰-۱۰
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عنوان انگلیسی Is-10: Design and Operation of A Multi- Product Cell Therapy GMP Manufacturing Facility in The USA
چکیده انگلیسی مقاله The cell therapy manufacturing facility at the Center for Cell and Gene Therapy (CAGT) is one of the largest of its type at an American academic institution. It was designed to prepare a wide variety of cellular products for use in (i) early phase clinical trials and (ii) to support hematopoietic transplant programs at the affiliated adult and pediatric teaching hospitals. In addition, CAGT operates a contiguous viral vector manufacturing facility to prepare vectors for gene therapy studies. CAGT manufactures over 1,000 products and intermediates annually in support of 50 Investigational New Drug trials. This presentation will discuss and contrast the design and operation of these facilities and their support laboratories. Issues will include handling of multiple product types, environmental monitoring, compliance with USA FDA regulations, documentation, quality assurance and control programs, manufacturing for other institutions, flexibility to meet future demands and operational budgets. Progress towards transitioning cellular therapy products from unique cell preparations for individual patients to off-the-shelf generic products will also be presented
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نشانی اینترنتی http://celljournal.org/journal/article/abstract/304
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