-
UnicoCell's cell bank is the leading allogeneic cell bank of adipose stem cell source in Taiwan, built in accordance with ICH regulations (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The stem cell product, ELIXCYTE®, cultured by the allogeneic cell bank has passed human clinical trials for knee osteoarthritis and chronic kidney disease.
UnicoCell's allogeneic stem cell bank is the best choice for cell starting material to be used for various indications in research units.
-
UnicoCell has been focusing on the development and application of new stem cell drugs for more than 10 years. Our cell production plant has been approved by TFDA under GTP guidance for Human Tissue Banks and human clinical trials, verified as a CPU (Cell Processing Unit) under RASMET (“The Regulation Governing the Application of Specific Medical Examination Technique and Medical Device”), and obtained the Accreditation Certificate of Foreign Cell Processor from Japan MHLW (Ministry of Health, Labor and Welfare).
With the same high standard of quality systems required by clinical trials, UnicoCell has partnered with major hospitals in Taiwan on autologous stem cell therapy for knee osteoarthritis.
-
UnicoCell has been focused on the development of stem cell related applications and technologies for the past decade.
During our study of cell culture method, we have developed a unique production method which can significantly increase the unit concentration of stem cell secretome compared to the traditional culture method. We have obtained an invention patent for our proprietary process of producing stem cell secretome.
-
The mass production process of stem cells developed by UnicoCell can increase the yield of a single batch compared to the traditional culture method. By increasing the yield, the production cost is significantly reduced with the price of cellular products more affordable for the regenerative medical needs and disease treatment.
-
UnicoVial®, a patented cryogenic vial, obtained approval of TFDA Class 2 medical device, received Acknowledgment letter of DMF (Drug Master File) from US FDA and won the 19th National Innovation Award.
UnicoVial® is ideal for storage of cell products and biological samples under ultra-low temperature, with a stopper invention specifically designed for clinical use.
-
UnicoCell's quality control laboratory has obtained ISO/IEC 17025 accrediation granted by Taiwan Accreditation Foundation (TAF).
We offer the following testing services: "sterility test", "endotoxin", "mycoplasma", "cell count and viability".