UnicoCell received notification from Japan's Ministry of Health, Labour and Welfare (MHLW) on May 10 that it has passed the inspection of its cell culture processing facility and obtained certification for the manufacture of designated cellular processed products recognized by Japan's Ministry of Health, Labour and Welfare.
UnicoCell stated that in preparation for entering Phase 3 clinical trials for new drugs and manufacturing cellular drugs after obtaining certification, it has completed the construction of a cell preparation factory with PIC/S GMP specifications. Not only has it obtained approval from Taiwan's Food and Drug Administration (TFDA) for human organ storage, clinical GTP laboratories, and special regulatory CPU inspections, but it has also passed inspections by Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
UnicoCell indicated that besides its own use, the production capacity of the cell preparation factory can also provide contract manufacturing services for cell preparations to other companies. The integration from new drug research and development to drug production has been completed in advance.
All products of UnicoCell adhere to advanced national standards. In addition to passing inspections in Japan for its cell preparation factory, the screening of allogeneic cell donors follows the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Ongoing clinical trials have been approved by Taiwan's TFDA and the U.S. FDA. The company has also obtained registration approval for its allogeneic cell bank from the U.S. FDA's Master File (MF).
Furthermore, UnicoCell's stem cell secretome, exosomes, and patented pharmaceutical-grade containers have also been registered in the U.S. FDA's Master File (MF). Stringent requirements are in place to ensure the international safety and quality of new drugs.
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