This is Taiwan’s first GTP (Good Tissue Practice) facility providing clinical-trial-grade human cell culture services. Over the past decade, it has helped multiple companies establish GTP-compliant management and production systems.
The facility offers short-, medium-, and long-term dedicated culture room rentals, contract manufacturing (CMO), and contract development and optimization (CDO) services.
- Apr 7, 2011: Three quality control tests accredited by TAF ISO/IEC 17025.
- Nov 8, 2007: Obtained Factory Registration Certificate from the Ministry of Economic Affairs.
- Oct 2, 2005: Acquired Pharmaceutical Manufacturer License and registered DMF with the U.S. FDA.
- Dec 13, 2002: Complied with the GTP (Good Tissue Practice) guidelines announced by the Department of Health (No. 0910078677).
1. GTP Services: Manufacturing and optimization of clinical cell therapy products, GTP training, and dedicated culture room rental.
2. Quality Control Testing: TAF ISO/IEC 17025–certified sterility, endotoxin, and mycoplasma testing.
3. Cryogenic Storage: Temporary liquid nitrogen storage for cell products produced at ITRI’s cell facility.
4. Customized Services: Regulatory consultation, facility design guidance, quality validation, pilot testing, method evaluation, and contract manufacturing.
Self-balancing programmable incubators
Automated liquid nitrogen storage tanks
Programmable cell freezing systems
Secure automated cell processing instruments
Ultra-low temperature freezers
Cleanroom HVAC system with real-time monitoring
Emergency power generator
Air-cooled chiller system
黃國魁 經理
+886-3-5912177
light@itri.org.tw