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SEC Filings


8-K
FIBROCELL SCIENCE, INC. filed this Form 8-K on 05/10/2018
Entire Document
 
 
Manufacturing Experience and Solutions Fibrocell’s existing cGMP cell therapy manufacturing facility in Exton, PA has been designated as the production site for FCX-007 and FCX-013 • ~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 • Previous experience with commercial cell therapy manufacturing • Site for remaining clinical and future commercial manufacture of FCX-007 and FCX-013 • Existing capacity to serve the U.S. RDEB market commercially • In-house manufacturing expertise for fibroblast-based autologous cell and gene therapy products • Multiple site inspections by FDA 18