2023.8.15 UnicoCell received Acknowledgment letter of MF (Master File) from US FDA for UnicoCell Conditioned Medium (UCCM)

UnicoCell has recently received an acknowledgment letter from the U.S. Food and Drug Administration (FDA), informing the approval of the company's Master File (MF) submission for UnicoCell Conditioned Medium (UCCM). This achievement marks another instance of UnicoCell obtaining FDA approval, following the previously approved allogeneic Cell Bank and cryogenic vial (UnicoVial). These approvals underscore UnicoCell's strength in research and development, as well as its recognition by international regulatory authorities.

UCCM has obtained a patent for its unique manufacturing process technology. Compared to traditional culture methods, this approach can significantly increase the unit concentration of stem cell secretions, beyond other similar products. The active ingredients of UCCM maintain optimal activity under the special stable preservation technique, and the annual production capacity is up to 2,000 Liters. The successful entry into the Japanese market, along with the enthusiastic response from customers, highlights UCCM's promising potential in exosome purification and cosmetics product applications.

UnicoCell has identified numerous active ingredients within UCCM, including growth factors, cytokines, proteoglycans, and polypeptides…etc. These components facilitate cell proliferation, immune regulation, anti-inflammatory responses, and angiogenesis. UnicoCell has explored the application of UCCM in various medical product developments for regenerative medicine, such as wound healing, hair follicle nutrition, and skin tissue protection. A collaborative effort with Hualien Tzu Chi Hospital has enabled the study of UCCM's potential to treat degenerative retinal diseases. In brief, the MF approval of UCCM obtained by UnicoCell will facilitate the review of technical documentation for collaborating partners and expedite the research and development timeline for their clinical or drug-related applications in the US. UCCM stands out as the optimal choice for the exosome business.


Contact: Terry Lee 

Phone: 886-2-27922699 

Mail: info@unicocell.com