Our In-House, cGMP Commercial-Scale Manufacturing Capabilities

Castle Creek Biosciences leverages its in-house, current good manufacturing practices (cGMP) commercial-scale manufacturing process to advance novel therapies for genetic diseases.

Clinical and Commercial-Scale Production Capabilities

Castle Creek’s in-house manufacturing facility is designed to scale autologous manufacturing of custom cell product batches for each patient. This facility can produce clinical and commercial-scale supply of the company’s investigational gene therapies, with space available for future expansion.

Located outside of Philadelphia in Exton, Pennsylvania, 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.

This in-house operation offers important long-term benefits for managing many aspects of manufacturing, quality control, supply chain and logistics. Oversight is maintained for all processes and timelines, along with the ability to plan for and ensure availability of cGMP vector to supply clinical trials and eventually, commercial demand.

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

Proven cGMP Systems and Processes

Castle Creek Biosciences has extensive onsite experience with the establishment and validation of cGMP systems required to scale gene therapy manufacturing for late phase and commercial supply. We also developed supports 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