UnicoCell BioMed is mainly dedicated to the research and development of new stem cell drug and the technology application of cell therapy. We look forward to providing new regenerative medical services for mankind
New drug development and manufacturing facilities
The new stem cell drug "ELIXCYTE" developed by UnicoCell BioMed has successively obtained the approval of Investigational New Drug (IND) Application by TFDA (CT21, CT31) and US-FDA (CT31) and has started the clinical trials. Currently, the two clinical trials of ELIXCYTE for the treatment of osteoarthritis and chronic kidney disease (CKD) have entered the phase II clinical trials. CT21 was also listed as a cell therapy index case by the Taiwan CDE.
In order to produce high-quality and high-safety stem cell drug and comply with regulatory requirements, the GTP (Good Tissue Practice) cell laboratory was completed and started operation in 2014, and it has successively passed the TFDA GTP laboratory inspection, TFDA human organ bank certification and Japan PMDA Overseas Cell Processing Center (CPC) verification and certification.
R&D energy and core technology
UnicoCell BioMed has a complete R&D team dedicated to the research of pharmacology of stem cell drug and manufacturing technology, including the development of in vitro pharmacological test platforms for analyzing the mechanism of actions (MOAs) and characteristics of stem cell product, and optimization of the manufacturing process. We have successfully developed the 3D bioreactor culture technology for ELIXCYTE manufacturing in commercial scale. This state-of-the-art manufacturing technology also won the 2020 Asia-Pacific Bioprocessing Excellence Awards (ABEA).
In addition to the new stem cell drugs development, we also provide the autologous cell processing service for the treatment projects approval by "Administrative Measures for the Implementation or Use of Medical Instruments for Inspection and Testing of Specific Medical Technologies" (referred to as the Special Management Act ). UnicoCell BioMed has also cooperated with many hospitals to apply for Special Management Act for cell therapy projects with different indications. With our exclusive and GMP-standardized manufacturing process and quality control, we can provide the best cells for the most effective and safe treatment of patients.
Vision and Mission
Looking forward to the future, in addition to continuing the current research and development of new stem cell drugs for the treatment of knee osteoarthritis and renal failure, we will also continue to develop the next generation of new cell therapy drugs for the current unmet medical needs. We hope that through the application of regenerative medicine and cell therapy, we can provide effective treatments that are different from traditional medicines, benefit more patients in need, and contribute to human health.