Facility design for manufacture of cell therapy products

• In: Hospital Pharmacy Section - Poster session
• At: Cairo (Egypt) (2005)
• Type: Poster
• Poster code: HPS-P-033
• 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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