Made Scientific and Regenicin announced a manufacturing relationship to advance NovaDerm, an autologous cultured skin substitute for severe burns and chronic wounds, toward a U.S. FDA Orphan product approval.
Under the agreement, Made Scientific will serve as the manufacturing partner for NovaDerm, providing end-to-end services at its Princeton, New Jersey GMP facility. The program establishes a clear pathway from technology transfer through GMP clinical production and regulatory support of Regenicin's Investigational New Drug (IND) submission and upcoming clinical trial.
"We are proud to work with Regenicin to advance NovaDerm into the clinic," said Syed T. Husain, Chairman and CEO of Made Scientific. "This collaboration reflects the strength of our manufacturing platform and our ability to execute complex autologous programs with the precision and regulatory rigor required for clinical success."
"Manufacturing a patient-specific treatment like NovaDerm requires a level of consistency and traceability that few CDMOs can deliver. Made Scientific's proven expertise in autologous manufacturing gives us confidence as we move toward our IND submission and first-in-human clinical trial," said Dr. K. E. Castro, PhD, Director of Clinical Studies at Regenicin.