Nikon CeLL Innovation to Provide End-to-End Solutions from Process Development to GCTP/GMP Manufacturing and Analytical Characterization of Human Mesenchymal Stem Cells and Extracellular Vesicles in Japan
Completion of Technology Transfer from RoosterBio, Inc., a US Company, at Commercial Manufacturing Scale
March 12, 2026
TOKYO - Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation, has completed the transfer of commercial manufacturing-scale technology from RoosterBio, Inc. (RoosterBio), a US company, for the processes of human mesenchymal stem cell (MSC) expansion, harvest, formulation, and cryopreservation in 2D flasks and stirred-tank 3D bioreactors*1, as well as the production, harvest, and purification of MSC-derived extracellular vesicles (EVs). This transfer establishes a framework for providing end-to-end solutions in Japan ranging from MSC and EV-related process development to GCTP*2 and GMP*3 manufacturing and analysis.
The completion of this technology transfer marks a major milestone for NCLi, which announced in 2025 a strategic license agreement with RoosterBio, a leading company with advanced stem cell technology. Leveraging RoosterBio's platform, which covers MSC and EV manufacturing from 2D flasks to 3D bioreactors reaching up to 50 liters in scale, NCLi will contribute more than ever to accelerating and stabilizing the speed of project development for customers undertaking drug development.
- *1Bioreactor: A bioreactor is a vessel, device, or system that provides a controlled environment for the cultivation of microorganisms, cells, or tissues to support their growth, metabolism, and product synthesis. NCLi is now using bioreactors for large-scale culture for regenerative medicine.
- *2GCTP: An abbreviation of Good Gene, Cellular, and Tissue-based Products Manufacturing Practice. Statement of conformity based on the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Regenerative Medical Products.
- *3GMP: An abbreviation of Good Manufacturing Practice. Statement of conformity based on the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs
About RoosterBio
RoosterBio accelerates human mesenchymal stem/stromal cell (MSC) and extracellular vesicle (EV) product and process development to fuel the rapid implementation of scalable advanced therapies. RoosterBio is driven by clients' success and creating a world where safe and effective regenerative medicines are rapidly developed and widely available on a global scale.
The information is current as of the date of publication. It is subject to change without notice.