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Facility design for manufacture of cell therapy products

  • At: 2005 FIP Congress in Cairo (Egypt)
  • Type: Poster
  • By: GALLELLI, Joseph (National Institutes of Health, The Clinical Center, Bethesda, Maryland, United States of America)
  • Co-author(s): Sabra (Pharmaceutical Services, DUBLIN, Ireland)
    Carter (National Institutes of Health, BETHESDA, MARYLAND, United States of America)
  • Abstract:

    U.S. medical centers and hospitals manufacturing cell and gene therapy

    products, including products for clinical trials, are required by the Food

    and Drug Administration to follow current Good manufacturing Practice

    (cGMP) regulations. This provides assurance that there is consistency

    between lots and that adequate controls are in place to..

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Last update 4 October 2019

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