Global Development of Regenerative Medicine Products in Compliance with Japanese, U.S. and European Regulatory Requirements
First written in FY2020-Q2. 12 of 22 entries say "Advanced", first in FY2020. Latest entry: 2026-09-24.
The whole theme swung hardest in 2025: 1 of 11 companies on the "Worse" side.
6 other companies' latest entry also says "Advanced".
- 2026-09-24Advancedfinance.yahoo.co.jp
「ReproCELL Incorporated obtains license from Kanagawa Prefecture to manufacture and market regenerative medicine products」
A new fact was reported that ReproCELL Incorporated obtained a license from Kanagawa Prefecture to manufacture and market regenerative medicine products, effective 18 September 2026. - FY2026AdvancedAnnual report
「In October 2025, Histocell (Spain), a partner company in which the company has invested, obtained GMP certification from the Spanish Agency of Medicines and Medical Devices (AEMPS) for manufacturing master cell banks (MCB) and working cell banks (WCB) using the company's clinical-use iPS cells.」
For a CDMO compliant with regulations in Japan, the United States and Europe, the Spanish partner company obtained GMP certification, establishing a contract manufacturing framework across 3 sites. - 2026-05-14AdvancedEarnings
「This has established a framework for the global expansion of our contract manufacturing business through a three-site network in Japan, the United States and Europe.」
Obtaining GMP certification for the Spanish site gave concrete form to a contract manufacturing structure spanning 3 sites in Japan, the United States and Europe. - FY2026-H1AdvancedAnnual report
「Furthermore, the company completed registration of these clinical-use iPS cells in the FDA Drug Master File (DMF).」
For clinical-use iPS cells compliant with regulations in Japan, the United States and Europe, the company completed FDA DMF registration, making its regulatory support for US approval applications concrete. - FY2025AdvancedAnnual report
「Furthermore, the company established a framework capable of providing an integrated service from iPS cell production through differentiation and regenerative medicine product manufacturing, and provides contract manufacturing services covering the entire process from securing donor cells to manufacturing finished products.」
Based on compliance with regulations in Japan, the United States and Europe, the company established an integrated contract manufacturing framework covering donor cell procurement, iPS cell production, differentiation and finished-product manufacturing, and has progressed to the service provision stage. - FY2025-H1AdvancedAnnual report
「In anticipation of growing demand, the company opened GMP-compliant cell processing facilities at REPROCELL USA in May 2024. It will expand its contract manufacturing business for regenerative medicine and other products by utilizing these two cell processing sites.」
For contract manufacturing of regenerative medicine products based on compliance with regulations in Japan, the United States and Europe, the company made its framework for expanding contract manufacturing through two sites in Japan and the United States concrete by opening GMP-compliant facilities in the United States in May 2024. - FY2024AdvancedAnnual report
「In addition to iPS cells, the company will also jointly undertake contract manufacturing with Histocell for regenerative medicine and other products using mesenchymal stem cells, as well as their secretomes and exosomes.」
For contract manufacturing of regenerative medicine products compliant with regulations in Japan, the United States and Europe, the company expanded the scope beyond iPS cells to include mesenchymal stem cell products and secretomes and exosomes. - FY2024-Q3RestatedAnnual report
「Furthermore, the company partnered with BioBridge (United States) and Histocell (Spain) to establish a framework capable of handling not only iPS cell production, but also downstream differentiation into various target cells and the manufacture of regenerative medicine and other products. It provides a high-value-added contract manufacturing service covering the entire process, from securing donor cells to producing iPS cells and manufacturing differentiated cells, in compliance with the regulations of Japan, the United States and Europe.」
The company has reconfirmed its framework for undertaking, in compliance with the regulations of Japan, the United States and Europe, the entire process from securing donor cells to producing iPS cells and manufacturing differentiated cells and regenerative medicine and other products. - FY2024-Q2RestatedAnnual report
「Furthermore, the company partnered with BioBridge (United States) and Histocell (Spain) to establish a framework capable of handling not only iPS cell production, but also downstream differentiation into various target cells and the manufacture of regenerative medicine and other products. It provides a high-value-added contract manufacturing service covering the entire process, from securing donor cells to producing iPS cells and manufacturing differentiated cells, in compliance with the regulations of Japan, the United States and Europe.」
Through partnerships with BioBridge and Histocell, the company has reconfirmed its framework for undertaking, in compliance with the regulations of Japan, the United States and Europe, the entire process from securing donor cells to producing iPS cells and manufacturing differentiated cells and regenerative medicine and other products. - FY2024-Q1AdvancedAnnual report
「Furthermore, the company partnered with BioBridge (United States) and Histocell (Spain) to establish a framework capable of handling not only iPS cell production, but also downstream differentiation into various target cells and the manufacture of regenerative medicine and other products. It provides contract manufacturing as a high-value-added service covering the entire process, from securing donor cells to producing iPS cells and manufacturing differentiated cells, in compliance with the regulations of Japan, the United States and Europe. In addition to iPS cells, the company will also jointly undertake contract manufacturing with Histocell for regenerative medicine and other products using mesenchymal stem cells, as well as their secretomes and exosomes.」
Through partnerships with BioBridge and Histocell, the company established a framework for contract manufacturing covering the entire process, from securing donor cells to producing iPS cells and manufacturing differentiated cells and regenerative medicine and other products, in compliance with the regulations of Japan, the United States and Europe. It has also expanded the scope to contract manufacturing of mesenchymal stem cell products and secretomes and exosomes. - FY2023-Q3AdvancedAnnual report
「Furthermore, the company partnered with BioBridge (United States) and Histocell (Spain) to establish a framework capable of handling not only clinical-use iPS cell production, but also downstream differentiation into various target cells and the manufacture of regenerative medicine and other products. Going forward, it will launch a high-value-added new business providing contract manufacturing for the entire process, from securing donor cells to producing iPS cells and manufacturing differentiated cells, in compliance with the regulations of Japan, the United States and Europe.」
Through partnerships with BioBridge in the United States and Histocell in Spain, the company established a framework capable of undertaking the entire process under the regulations of Japan, the United States and Europe, from securing donor cells to producing iPS cells and manufacturing differentiated cells. - FY2023-Q2RestatedAnnual report
「The "GMP-iPS Cell Master Cell Bank" mass-produces iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, and supplies them to pharmaceutical companies and others as starting materials for regenerative medicine products. Because the company's iPS cells comply with the regulations of all three regions, Japan, the United States and Europe, they can be used widely in those markets, which is a key strength.」
The company has reconfirmed its policy of mass-producing and supplying GMP-iPS cells compliant with the regulations of Japan, the United States and Europe. - FY2023-Q1RestatedAnnual report
「The "GMP-iPS Cell Master Cell Bank" mass-produces iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, and supplies them to pharmaceutical companies and others as starting materials for regenerative medicine products. Because the company's iPS cells comply with the regulations of all three regions, Japan, the United States and Europe, they can be used widely in those markets, which is a key strength. In August 2021, the company entered into a strategic business partnership agreement with the TEXCELL Group, a French contract manufacturing organization (CMO) for pharmaceuticals, hereinafter referred to as TEXCELL.」
The company has reconfirmed its policy of mass-producing and supplying GMP-iPS cells compliant with the regulations of Japan, the United States and Europe, and its partnership with TEXCELL. - FY2022-Q3RestatedAnnual report
「The "GMP-iPS Cell Master Cell Bank" mass-produces iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, and supplies them to pharmaceutical companies and others as starting materials for regenerative medicine products. Because the company's iPS cells comply with the regulations of all three regions, Japan, the United States and Europe, they can be used widely in those markets, which is a key strength. In August 2021, the company entered into a strategic business partnership agreement with the TEXCELL Group, a French contract manufacturing organization (CMO) for pharmaceuticals, hereinafter referred to as TEXCELL.」
The company has reconfirmed its policy of mass-producing and supplying GMP-iPS cells compliant with the regulations of Japan, the United States and Europe, and its partnership with TEXCELL. - FY2022-Q2AdvancedAnnual report
「In August 2021, we entered into a basic agreement with the TEXCELL Group, a French contract manufacturing organization (CMO), hereinafter referred to as TEXCELL. TEXCELL has extensive experience in contract manufacturing of GMP master cell banks in accordance with Japanese, U.S. and European guidelines. By combining our cutting-edge clinical-use iPS cells with TEXCELL's manufacturing technology, we will provide more reliable GMP-iPS Cell Master Cell Banks.」
For the clinical-use iPS cell business based on compliance with regulations in Japan, the United States and Europe, the company made its GMP master cell bank manufacturing framework concrete through a basic agreement with TEXCELL. - FY2022-Q1RestatedAnnual report
「Because the company's iPS cells comply with the regulations of all three regions, Japan, the United States and Europe, they can be used widely in those markets, which is a key strength.」
The company has reconfirmed its policy of developing and supplying clinical-use iPS cells that comply with the regulations of Japan, the United States and Europe. - FY2021AdvancedAnnual report
「The "GMP-iPS Cell Master Cell Bank" mass-produces iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, and supplies them to pharmaceutical companies and others as starting materials for regenerative medicine products. Compliance with regulations in Japan, the United States and Europe is a key strength.」
The company's three-region regulatory compliance policy was made concrete as a new service supplying GMP-compliant iPS cells to pharmaceutical companies. - FY2021-Q3RestatedAnnual report
「Under this service, we custom-manufacture clinical-use iPS cells based on customer needs and in accordance with the regulations of each region.」
The company has reconfirmed its policy of offering a service designed to comply with global regulations by manufacturing clinical-use iPS cells according to customer needs and in accordance with the regulations of each region. - FY2021-Q2RestatedAnnual report
「Under this service, we custom-manufacture clinical-use iPS cells based on customer needs and in accordance with the regulations of each region.」
The company has reconfirmed its policy of offering a service designed to comply with global regulations by manufacturing clinical-use iPS cells according to customer needs and in accordance with the regulations of each region. - FY2021-Q1RestatedAnnual report
「Under this service, we custom-manufacture clinical-use iPS cells based on customer needs and in accordance with the regulations of each region.」
The company has reconfirmed its policy of expanding a clinical-use iPS cell manufacturing service by leveraging its bases in Japan, the United States and the United Kingdom and compliance with the regulations of each region. - FY2020AdvancedAnnual report
「Under this service, we custom-manufacture clinical-use iPS cells in accordance with the regulations of each region.」
The company launched a clinical-use iPS cell manufacturing service based on compliance with regulations in Japan, the United States and Europe, moving its three-region regulatory compliance and global development policy into an actual service. - FY2020-Q2First statedAnnual report
「Furthermore, because the company has bases in Japan, the United States and Europe, it is familiar with the regulations and guidelines in each region and is developing clinical-use iPS cells and regenerative medicine products that comply with the regulations of all three regions. By addressing the regulations of all three regions from the early stages of development, the company aims to develop regenerative medicine products that can be launched globally.」
The company has disclosed for the first time, as a standalone theme, its policy of developing clinical-use iPS cells and regenerative medicine products compliant with regulations and guidelines in Japan, the United States and Europe, with global deployment as the goal by addressing the regulations of all three regions from the early stages of development.