UnicoCell Biomed Co., Ltd. (“UnicoCell”) is sharing good news again that we have received a notification from Japan MHLW (Ministry of Health, Labor and Welfare) on 10th May and which is an Accreditation Certificate of Foreign Cell Processor to certified that UnicoCell has passed the onsite inspection of cell processing facility.
In order to conduct to phase III clinical trials and to prepare the cell production following NDA (new drug applications), UnicoCell has completed the construction of a PIC/S GMP- compliant cell production plant, which has been approved by TFDA under GTP guidance for Human Tissue Banks, human clinical trials and RASMET CPU (“The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device” Cell Processing Unit). So, this Accreditation approved by Japan PMDA (Pharmaceuticals and Medical Devices Agency) firmly conformed that UnicoCell, as a new drug develop company, shall have extreme self-discipline by multiple verifications. In addition to internal demands, UnicoCell is also capable for providing CDMO services on cell production to other biotech or corporations, whereby UnicoCell holds a leading position in completing the integration from new drug research and development to new drug production.
UnicoCell adopt the requirements of advanced countries and applied to all the product development. Along with the Accreditation approved by Japan PMDA lately, donor selection of allogeneic stem cell which complied with the guidelines of ICH (the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), all the ongoing clinical trials approved by TFDA and US FDA, the allogeneic cell bank with US FDA's raw material Master File acknowledgement; moreover, the stem cell Secretome and the patented medical device-grade cryogenic vial are also acknowledged by US FDA Master File, it demonstrated UnicoCell has strict requirements for the safety of new drugs and internationally recognized quality.
Contact: Terry Lee
Phone: 886-2-27922699
Mail: info@unicocell.com