UnicoCell, which has been dedicated to the research and development of allogeneic adipose stem cells in regenerative medicine for more than 10 years, has recently received an acknowledgement letter from the U.S. Food and Drug Administration (FDA) informing the company’s DMF submission for allogeneic cell bank has been reviewed and is expected to be listed on the FDA website in December 2022. To be enlisted on the list of DMFs by the U.S. FDA has testified the research and development capabilities of UnicoCell, and provided a credit for the expansion of our business to the global market.
Safety is the first priority in the development of new drugs. The Drug Master Files (DMFs) is a complete set of information reflecting the production and quality control of active pharmaceutical ingredients (API), including aspects of manufacturing plants, manufacturing processes, specifications, testing methodology, and stability etc. Therefore, the submission, review and public notice of DMFs list can be treated as the way to strictly control the source and ensure the quality of API. It can be used to significantly reduced the time consuming for evaluation and approval of new drug launch. In addition to be applied for UnicoCell’s new drug candidates, the information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these (Drug Master Files: Guidelines, Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services), it offer guidance on acceptable approaches to meeting regulatory requirements, which in turn will be beneficial to the promotion of UnicoCell’s cell products to the global market.
Based on the well established and integrated development of stem cell research and development, UnicoCell has built up a complete allogeneic adipose stem cell bank system, from donor eligibility to cell bank establishment, which has been established in accordance with ICH regulations, and the source and quality of the cells have been tested in clinical trials and published scientifically. In addition to the development of new drugs for clinical trials, the cell bank can also be used as the best choice for cell starting material to be used for the development and research of various indications in the industrial research units.
Contact: Terry Lee