Our In-House, cGMP Commercial-Scale Manufacturing Capabilities

Castle Creek Biosciences is leveraging our dual platform of ex vivo and in vivo technologies and in-house, current good manufacturing practices (cGMP), commercial-scale manufacturing process to develop novel therapies for a broad range of genetic diseases.

Clinical and Commercial-Scale Production Capabilities

Castle Creek’s 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 86,500 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 cGMP facility benefits from the validated systems and processes previously implemented at the site for manufacture of an FDA-approved autologous cell therapy product marketed by the company’s predecessor.

Our in-house operation offers important long-term benefits for managing many aspects of manufacturing, quality control, logistics, and supply chain and maintaining oversight of all processes and timelines throughout different stages of production, as well as having 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 or scale-our 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