Manufacturing

Manufacturing

Our In-House, cGMP Commercial-Scale Manufacturing Capabilities

Castle Creek Biosciences is leveraging our proprietary, autologous fibroblast technology platform and in-house, current good manufacturing practices (cGMP), commercial-scale manufacturing infrastructure to develop personalized cell and gene therapies for underserved disorders with high unmet medical needs.

Clinical and Commercial-Scale Production Capabilities

Castle Creek Biosciences’ existing, in-house manufacturing facility has been designed specifically to support the scale of autologous manufacturing that provides custom batches of cell product for each patient on an individual basis. Our facility has the capability to produce clinical and future commercial-scale supply of the company’s investigational gene therapies, with space available for future expansion.

Located outside of Philadelphia in Exton, PA, our ~90,000 square foot facility has ~13,000 square feet of cGMP manufacturing space—an integrated operation with cleanroom manufacturing, cryogenic storage, quality control laboratories and shipping/receiving areas. Manufacture of our investigational gene therapies is served by multiple segregated production zones. Our facility has a long history of manufacturing autologous fibroblasts and has been previously inspected by the U.S. Food and Drug Administration for commercial manufacture of autologous fibroblasts.

Our in-house manufacturing operation offers important long-term benefits including internal quality control and oversight of all processes, as well as the ability to plan for and ensure availability of cGMP vector to supply clinical trials and eventually, commercial demand.

Proven cGMP Systems and Processes

Castle Creek Biosciences has extensive experience at our facility with the establishment and validation of cGMP systems required to scale-up gene therapy manufacturing for late phase and commercial supply. We have also developed support systems for the manufacture and distribution of autologous therapies including:

  • Quality control systems
  • Customer service
  • Tracking and traceability processes
  • Aseptic control
  • Inventory management
  • A raw material testing program
  • Cold-chain distribution to ensure cell viability, sterility and potency are maintained during transport