Development and Supply of an iPS Cell Bank for Clinical Applications
First written in FY2017. 13 of 21 entries say "Advanced", first in FY2020. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「In March 2026, we launched an MCB manufacturing service for clinical-use iPS cells at the GMP manufacturing facility of REPROCELL USA Inc. in the United States.」
Regarding the infrastructure for supplying clinical-use iPS cells, the company launched an MCB manufacturing service at a U.S. GMP facility and established an end-to-end system covering donor selection, seed clone production, gene editing and GMP cell banking. - 2026-05-14AdvancedEarnings
「In March 2026, we launched an MCB manufacturing service for clinical-use iPS cells at the GMP manufacturing facility of REPROCELL USA Inc. in the United States. This established a system under which the Group can provide an integrated end-to-end workflow, from donor selection, seed clone manufacturing and clinical-use gene editing using StemEdit™ through GMP cell banking.」
The disclosure describes the launch of an MCB manufacturing service for clinical-use iPS cells in the United States and the establishment of an end-to-end service structure. - FY2026-H1AdvancedAnnual report
「We have also completed registration of these clinical-use iPS cells in the FDA Drug Master File (DMF). This simplifies the procedures for companies using our clinical-use iPS cells when filing for approval in the United States, significantly improving customer convenience.」
The company stated that it had completed FDA DMF registration for its clinical-use iPS cells, representing progress in the supply infrastructure that simplifies customer companies’ procedures for seeking approval in the United States. - FY2025AdvancedAnnual report
「In February 2025, Gameto Inc. of the United States, which is supplied with the clinical-use iPSC "StemRNA™ Clinical iPSC Seed Clone" by the Group, obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its "Fertilo" in vitro oocyte maturation technology using the iPSCs to conduct Phase III clinical trials.」
The company stated that Gameto, a recipient of its clinical-use iPS cells, obtained FDA IND clearance for a Phase III clinical trial, marking concrete progress toward a product developed by another company using the company’s cells entering the clinical trial stage in the United States. - FY2025-H1AdvancedAnnual report
「To date, we have operated the Ton町-Reprocell Regenerative Medicine Center, a cell-processing facility within the Kanagawa Life Innovation Center that is licensed under the “Manufacturing License for Specified Cell-Processed Products” (facility number: FA3200006). In anticipation of growing demand, in May 2024 we newly opened GMP-compliant cell-processing facilities at REPROCELL USA. We will expand our contract manufacturing business for regenerative medicine products by utilizing these 2 cell-processing facilities in Japan and the United States.」
Regarding the infrastructure for supplying clinical-use iPS cells and regenerative medicine products, the company opened GMP-compliant cell-processing facilities at its U.S. subsidiary in May 2024, expanding the system to 2 sites in Japan and the United States. - FY2024AdvancedAnnual report
「We are supplying our clinical-use iPS cells for the many regenerative medicine projects promoted by the institute.」
Regarding the supply of clinical-use iPS cells, the company stated that it is proceeding with supply for the institute’s numerous projects under its basic agreement with the California Institute for Regenerative Medicine. - FY2024-Q3AdvancedAnnual report
「In October 2023, we entered into an agreement with Gameto (U.S.) for the supply and licensing of clinical-use iPS cells.」
Regarding the clinical-use iPS cell supply and platform business, the company entered into a supply and licensing agreement with U.S.-based Gameto, specifically expanding its customers and partners. - FY2024-Q2RestatedAnnual report
「The “GMP-iPS Cell Master Cell Bank” involves the large-scale manufacture of iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, for supply to pharmaceutical companies and others as starting materials for regenerative medicine products.」
The company has reaffirmed its business of manufacturing GMP-compliant iPS cells on a large scale and supplying them to pharmaceutical companies and others as starting materials for regenerative medicine products. - FY2023-Q3AdvancedAnnual report
「In October 2022, we entered into a memorandum of understanding for the Industry Alliance Program with the California Institute for Regenerative Medicine, one of the world’s largest organizations supporting regenerative medicine. Going forward, we will supply our clinical-use iPS cells for the many regenerative medicine projects promoted by the institute.」
Regarding the supply of clinical-use iPS cells, the company entered into a memorandum of understanding for the Industry Alliance Program with the California Institute for Regenerative Medicine, creating specific opportunities to supply cells for numerous regenerative medicine projects. - FY2023-Q2RestatedAnnual report
「The “GMP-iPS Cell Master Cell Bank” involves the large-scale manufacture of iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, for supply to pharmaceutical companies and others as starting materials for regenerative medicine products.」
The company has reaffirmed its clinical-use iPS cell business of manufacturing GMP-compliant iPS cells on a large scale and supplying them to pharmaceutical companies and others as starting materials for regenerative medicine products. - FY2023-Q1AdvancedAnnual report
「In February 2022, to expand distribution channels, we opened a store on Kanden Kurashi Mall, an e-commerce marketplace operated by Kansai Electric Power Company. We will continue to actively promote the business.」
For the supply and services related to clinical-use iPS cells, the company expanded the distribution channel for Personal iPS to Kanden Kurashi Mall. - FY2022-Q3RestatedAnnual report
「In June 2021, we also opened a dedicated manufacturing facility, the “Seed iPSC Manufacture Suite (SiMS),” for these clinical-use iPS cells within our U.S. subsidiary.」
The company has reaffirmed its policy of using the dedicated SiMS manufacturing facility opened within its U.S. subsidiary as an infrastructure for supplying clinical-use iPS cells. - 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.」
The company made its infrastructure for supplying clinical-use iPS cells more concrete through an agreement with TEXCELL for a GMP master cell bank manufacturing system compliant with Japanese, U.S. and European guidelines. - FY2022-Q1AdvancedAnnual report
「In June 2021, we also opened a dedicated manufacturing facility, the “Seed iPSC Manufacture Suite (SiMS),” for these clinical-use iPS cells within our U.S. subsidiary.」
To establish an infrastructure for supplying clinical-use iPS cells, the company opened the dedicated SiMS manufacturing facility within its U.S. subsidiary in June 2021. - FY2021AdvancedAnnual report
「The “GMP-iPS Cell Master Cell Bank” involves the large-scale manufacture of iPS cells in compliance with GMP (Good Manufacturing Practice), the regulations governing pharmaceutical manufacturing, for supply to pharmaceutical companies and others as starting materials for regenerative medicine products.」
The company launched a specific service for the planned supply of clinical-use iPS cells, involving GMP-compliant large-scale manufacturing and supply to pharmaceutical companies. - FY2021-Q3RestatedAnnual report
「To date, we have provided a service for producing “research-use iPS cells” for research purposes, including drug discovery. In March 2020, drawing on our technology and experience to date, we launched a service for producing “clinical-use iPS cells.” Going forward, we will actively expand this as an iPS cell platform business.」
The company has reaffirmed its policy of expanding its clinical-use iPS cell production service as an iPS cell platform business. - FY2021-Q2RestatedAnnual report
「In March 2020, we launched a service for producing “clinical-use iPS cells.” Going forward, we will actively expand this as an iPS cell platform business.」
The company has reaffirmed its policy of expanding its clinical-use iPS cell production service as an iPS cell platform business. - FY2021-Q1RestatedAnnual report
「In March 2020, we launched a service for producing “clinical-use iPS cells.” Going forward, we will actively expand this as an iPS cell platform business.」
The company has reaffirmed its policy of expanding its clinical-use iPS cell production service as an iPS cell platform business. - FY2020AdvancedAnnual report
「In March 2020, we launched a service for producing “clinical-use iPS cells.” Going forward, we will actively expand this as an iPS cell platform business.」
The company launched a service for producing clinical-use iPS cells and began developing it into a platform business by leveraging its bases in Japan, the United States and the United Kingdom and each region’s regulatory capabilities. - FY2018-Q3RestatedAnnual report
「In the medical business, we are pursuing the clinical application of this technology and promoting the sale and supply of regenerative medicine products and iPS cells used as raw materials for such products.」
The company has reaffirmed its policy of pursuing the clinical application of RNA reprogramming technology and the sale and supply of regenerative medicine products and the iPS cells used as raw materials for those products. - FY2017First statedAnnual report
「Through this iPSC bank, we will broadly supply cells for regenerative medicine to medical institutions and companies, and will promote the industrialization of iPSC-based regenerative medicine going forward.」
The company first set out its plan to develop an iPSC bank for clinical applications using RNA reprogramming technology and supply cells to medical institutions and companies.