The Nikon CeLL innovation (NCLi) facility is centrally located in the Koto area of Tokyo, approximately 9 kilometers from Tokyo Station, 20 kilometers from Haneda International Airport, and 65 kilometers from Narita International Airport. The facility is one of the largest contract development and manufacturing organization (CDMO) facilities in Japan, with over 7500 m2 of floor space over two levels, including of clean room space. The facility is highly flexible and includes process development laboratories, current Good Manufacture Practice (cGMP) manufacturing suites, Quality Control labs, support areas, and space for future expansion.
The facility is designed and built to meet the expectations of regulators for the commercial production of advanced therapeutics and aseptic fill/finish. Considerations have been taken specifically for material, personnel, product, and waste flows as well as product isolation and segregation. Clean rooms, temperature control equipment, and other critical production equipment are monitored 24/7 through a Building Monitoring System with remote alarm notification. In addition, the facility has both Uninterruptible Power Supply (UPS) and back-up power generators in the event of power outage.
- GCTP ： Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
- GMP ： Good Manufacturing Practice
- CDMO ： Contract Development and Manufacturing Organization