title: Design and operation of a current good manufacturing practices cell-engineering laboratory.
abstract: Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support.
authors.affiliation: Cell Therapy Clinical Laboratory, University of Minnesota, Fairview-University Medical Center, Box 609 Mayo Building, 420 Delaware Street SE, Minneapolis, MN 55455, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Burger
mesh_terms: D001688:Biological Products / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D002138:Calibration; D016903:Drug Monitoring; D005160:Facility Design and Construction / Q000592:standards*; D011786:Quality Control; D012499:Sanitation
chemical_list: D001688:Biological Products