CMO / Manufacturing Services
GCTP/GMP compliant cell and gene therapy
manufacturing services for both local and global supply
- Suites comply with Japanese, U.S., European, and ISO standards for clean rooms utilized in aseptic manufacturing.
- Both adherent and suspension based cell culture processes from small scale to large scale,
- Clinical through commercial phase products
- Flexible facility design for customization to process
- Product segregation via dedicated air handling systems
- Validated cleaning and change-over practices to eliminate the possibility of cross contamination
- GCTP ： Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
- GMP ： Good Manufacturing Practice
- CDMO ： Contract Development and Manufacturing Organization
