Nikon CeLL Innovation Enters into a Strategic License Agreement with RoosterBio, a US Company, to Enable GCTP/GMP Manufacturing Platform of Human Mesenchymal Stem Cells and Extracellular Vesicle in Japan

Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation has entered into a strategic licensing agreement with RoosterBio, Inc. (RoosterBio), a leading stem cell technology company in the US.

This agreement provides the Japanese biopharma industry with an end-to-end solution for development and manufacturing of human mesenchymal stem cells (MSC) and extracellular vesicle (EV) therapeutics. Drug developers can leverage RoosterBio’s technology platform to accelerate the development of their advanced therapies with NCLi, and then seamlessly transition to clinical manufacturing within NCLi’s GCTP^*1/GMP^*2 facility designed specifically for cell therapies.

Through this collaboration, NCLi’s capabilities include cell expansion, harvest, formulation, and cryopreservation of MSC in 2D flasks and 3D bioreactor^*3, as well as downstream processing for EV purification and drug product manufacturing. RoosterBio and NCLi have successfully completed 2D flasks and 3D bioreactor MSC and EV technology transfer activities at clinically relevant manufacturing scales.

• *1GCTP: An abbreviation of Good Gene, Cellular, and Tissue-based Products Manufacturing Practice. Statement of conformity based on Ministerial Ordinance regarding manufacturing management and quality control for regenerative medicine products.
• *2GMP: An abbreviation of Good Manufacturing Practice. Statement of conformity based on Ministerial Ordinance regarding pharmaceutical products and quasi-drugs.
• *3bioreactor: A device that uses microorganisms and enzymes to synthesize and decompose substances. It is now used for large scale cell culture for Regenerative medicine.

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.

• RoosterBio Website

• Nikon CeLL innovation Co., Ltd.