In a significant move for the regenerative medicine sector, Made Scientific, Inc. and Regenicin, Inc. announced a strategic manufacturing relationship on Wednesday. The partnership aims to propel NovaDerm, a breakthrough autologous cultured skin substitute, through clinical trials and toward U.S. FDA Orphan product approval.
The collaboration centers on treating patients with severe burns and chronic wounds using tissue-engineered skin grafts created from their own cells.
Under the new agreement, Made Scientific—a specialized cell therapy Contract Development and Manufacturing Organization (CDMO)—will handle the end-to-end production of NovaDerm at its state-of-the-art GMP facility in Princeton.
The partnership provides a comprehensive roadmap for Regenicin, covering:
- Technology Transfer: Transitioning the specialized graft-building process to a scalable environment.
- GMP Clinical Production: Manufacturing the patient-specific skin substitutes under strict regulatory standards.
- Regulatory Support: Assisting with Regenicin’s Investigational New Drug (IND) submission and subsequent clinical trials.
Unlike traditional skin grafts that require significant “harvesting” of healthy skin from other parts of a patient’s body, NovaDerm uses a patient’s own skin cells to grow a living, regenerative substitute. This process reduces the trauma of tissue harvesting and is designed to shorten hospital stays for those with life-threatening burns.
“Manufacturing a patient-specific treatment like NovaDerm requires a level of consistency and traceability that few CDMOs can deliver,” Dr. K. E. Castro, Director of Clinical Studies at Regenicin, said. “Made Scientific’s proven expertise in autologous manufacturing gives us confidence as we move toward our first-in-human clinical trial.”
Syed Husain, Chairman and CEO of Made Scientific, added that the collaboration reflects the firm’s ability to execute complex programs with the “regulatory rigor required for clinical success.”
This partnership highlights the growing influence of the New Jersey life sciences corridor. Made Scientific, supported by its strategic backer GC Corporation, has positioned itself as a key player in the development of both autologous (patient-derived) and allogeneic (donor-derived) cell therapies.
For Regenicin, which has been developing regenerative therapies since 2010, the move to a New Jersey-based manufacturing partner represents a critical step in bringing its flagship product to the commercial market.
