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SEC Filings


8-K
FIBROCELL SCIENCE, INC. filed this Form 8-K on 12/29/2017
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Fibrocell’s existing cGMP cell therapy manufacturing facility in Exton, PA has been designated as the production site for FCX-007 after incorporation into the IND • ~13,000 square foot facility includes:  Cleanroom for cell culture manufacturing  On-site quality control testing laboratories  Cryogenic storage Warehouse and distribution areas  Centrally monitored • Site for remaining clinical and future commercial manufacture of FCX-007, with capacity to serve the U.S. RDEB market • In-house manufacturing expertise for fibroblast-based autologous cell and gene therapy products • Previous experience with commercial autologous fibroblast manufacturing • Multiple site inspections by FDA Manufacturing Experience and Solutions 15