FREDERICK, Md., April 15, 2025 /PRNewswire/ -- 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.
"We are very pleased to announce this strategic license agreement with RoosterBio, marking a significant milestone in broadening NCLi's capabilities as a CDMO," said Toshiyuki Nakayama, President of NCLi. "NCLi has extensive proven track records in clinical and commercial manufacturing at the Tokyo facility, one of the largest in Japan. Through this partnership, by leveraging RoosterBio's state-of-the-art technology platform, we believe we can deliver high-quality regenerative medicines to more patients in a rapid and stable manner. We are excited to be able to accelerate our role as an infrastructure for industrializing regenerative medicines in Japan."
"NCLi has built a world-class facility and team to meet the needs of the biopharmaceutical industry, especially in Japan where so much innovation in cell and gene therapy is happening," said Tim Kelly, Chief Executive Officer of RoosterBio. "By combining RoosterBio's proven technology with NCLi's process development and manufacturing expertise, we will deliver a truly unique and enabling solution for scalable, cost-effective production of advanced therapies. We are delighted to partner with NCLi to translate our collective capabilities into lifesaving treatments for patients."
*1 GCTP: 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.
*2 GMP: An abbreviation of Good Manufacturing Practice. Statement of conformity based on Ministerial Ordinance regarding pharmaceutical products and quasi-drugs.
*3 bioreactor: A device that uses microorganisms and enzymes to synthesize and decompose substances. It is now used for large scale cell culture for Regenerative medicine.
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.
About NCLi
Nikon CeLL innovation Co., Ltd. (NCLi) operates a reliable Cell and Gene therapy facility in Japan, offers broad selection of contract development and manufacturing (CDMO) services. NCLi facility is centrally located in Tokyo, and one of the largest CDMO facility in Japan and provide CDMO services for early- to late-phase clinical and commercial cell and gene therapy products, to the biotech and pharmaceutical customers.