- Made Scientific and Regenicin have entered a manufacturing agreement to advance NovaDerm, an autologous skin therapy, toward FDA Orphan Product Approval.
- Made Scientific will provide end-to-end GMP contract manufacturing services from its New Jersey facility, supporting IND submission and clinical trials.
Made Scientific, Inc. has entered into a manufacturing agreement with Regenicin, Inc. to support the development of NovaDerm, an autologous cultured skin substitute for severe burns and chronic wounds. The collaboration focuses on advancing the therapy toward a U.S. FDA Orphan Product Approval pathway and upcoming clinical evaluation.
Under the agreement, Made Scientific, a U.S.-based CDMO, will provide end-to-end contract manufacturing services at its GMP facility in Princeton, New Jersey. The scope includes technology transfer, GMP clinical production, and regulatory support for Regenicin’s Investigational New Drug (IND) submission and planned clinical trial.
The partnership is designed to establish a structured pathway from development through clinical-stage manufacturing. NovaDerm is a patient-specific therapy, requiring controlled production processes and traceability across manufacturing stages. Made Scientific’s role includes supporting these requirements as the program progresses toward first-in-human studies.
“We are proud to work with Regenicin to advance NovaDerm into the clinic.”
Syed T. Husain, Chairman and CEO of Made Scientific
Regenicin stated that the collaboration will support its clinical development plans by leveraging Made Scientific’s experience in autologous manufacturing. The companies indicated that the program will move forward with IND submission and clinical trial readiness as part of the agreement.
