Nikon Completes Technology Transfer for Human Mesenchymal Stem Cell Processing
In a significant development, Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation, has successfully transferred commercial manufacturing-scale technology from RoosterBio Inc., a US-based company, for the processes of human mesenchymal stem cell (MSC) expansion, harvest, formulation, and cryopreservation in 2D flasks and stirred-tank 3D bioreactors. Additionally, the transfer also includes the production, harvest, and purification of MSC-derived extracellular vesicles (EVs). This transfer sets the stage for offering comprehensive solutions in Japan, covering MSC and EV-related process development, as well as GCTP and GMP manufacturing and analysis.
The completion of this technology transfer represents a significant milestone for NCLi, following a strategic licensing agreement with RoosterBio in 2025. By leveraging RoosterBio’s advanced stem cell technology platform, which spans MSC and EV manufacturing from 2D flasks to 3D bioreactors with capacities up to 50 liters, NCLi aims to enhance its support for customers engaged in drug development projects by accelerating and streamlining the development process.
Bioreactors play a crucial role in large-scale culture for regenerative medicine, providing a controlled environment for the cultivation of microorganisms, cells, or tissues to support their growth, metabolism, and product synthesis. NCLi’s utilization of bioreactors signifies a step towards advancing regenerative medicine technologies on a larger scale.
GCTP, short for Good Gene, Cellular, and Tissue-based Products Manufacturing Practice, pertains to a statement of conformity based on the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Regenerative Medical Products. On the other hand, GMP, which stands for Good Manufacturing Practice, relates to a statement of conformity based on the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs. Adhering to these standards ensures the quality and reliability of the manufacturing processes for regenerative medical products and pharmaceuticals.
About RoosterBio
RoosterBio is at the forefront of accelerating human mesenchymal stem/stromal cell (MSC) and extracellular vesicle (EV) product and process development to facilitate the rapid implementation of scalable advanced therapies. With a strong focus on client success and the vision of making safe and effective regenerative medicines more accessible globally, RoosterBio is committed to driving innovation in the field of regenerative medicine.
In conclusion, the successful technology transfer from RoosterBio to NCLi represents a significant step forward in advancing the capabilities of stem cell processing and regenerative medicine in Japan. By incorporating cutting-edge technologies and processes, NCLi is poised to play a key role in supporting the development of novel therapies and treatments for various medical conditions. As the field of regenerative medicine continues to evolve, collaborations and partnerships like the one between NCLi and RoosterBio will be instrumental in driving innovation and fostering the growth of this critical industry.
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