Introduction
UnicoCell possesses the only allogeneic stem cell bank in Taiwan approved by the U.S. FDA, complying with international regulatory requirements and applicable in diverse regenerative medicine fields. The robust manufacturing process, combined with large-scale cell product production technology and long-term stability verification, ensures batch stability of cell products. This benefits the Taiwanese population's regenerative medical needs and disease treatments, establishing a crucial foundation for clinical trials, commercial production, or CDMO services.
Features / strengths
One-Stop High-Quality Contract Manufacturing Services
1. UnicoCell allogeneic stem cell bank is the only one obtained U.S. FDA DMF
approval in Taiwan.
2. Cell bank products approved for phase 3 human clinical trials
3. Multi-national patented medical-grade biologics preservation containers
4. Production and sale of high-concentration human-derived exosome raw
materials
5. PIC/S GMP-standard cell product manufacturing facilities and Japanese CPC
certification
6. ISO/TAF-certified laboratory testing services
Specification in detail
Content
Human adipose-derived stem cell