MCB/WCB Manufacturing and Establishment of a Stable Supply System with Nikon Cell Innovation
First written in FY2021-Q3. 7 of 11 entries say "Advanced", first in FY2022-Q2. Latest entry: 2026-05-14.
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- 2026-05-14AdvancedEarnings
「For a next-generation mass-culture technology aimed at commercial manufacturing, we developed a proprietary manufacturing process optimized for the characteristics of SQ-SHED with the cooperation of US-based Corning Life Sciences, a global manufacturer of culture equipment.」
A proprietary mass-culture manufacturing process for SQ-SHED was developed with commercial manufacturing and cost reduction in mind. - FY2026-H1AdvancedAnnual report
「Regarding next-generation large-scale cell culture technology for commercial manufacturing, the company developed a proprietary manufacturing process optimized for SQ-SHED with the support of Corning Life Sciences of the United States, a global manufacturer of cell-culture equipment. The company is currently making steady progress with development under a joint development agreement with NIPRO CORPORATION, which operates a CDMO business, for the purpose of establishing manufacturing processes for late-stage clinical trials and commercial manufacturing.」
In addition to the existing MCB and WCB manufacturing system, the Company progressed to the development of a proprietary mass-culture method with the support of Corning Life Sciences and commercial manufacturing process development with Nipro. - FY2025AdvancedAnnual report
「Furthermore, with a view to applying the process to late-stage clinical trials and commercial manufacturing, the Company entered into a joint development agreement with Nipro, which operates a contract manufacturing business, for full-scale process development, and has completed the transfer of technology from Escator.」
The SHED manufacturing system progressed toward process development for late-stage clinical and commercial manufacturing through the execution of a joint development agreement with Nipro and completion of the technology transfer from Escator. - FY2025-H1AdvancedAnnual report
「Furthermore, in March 2024, as a first step toward entering overseas markets, the Company completed manufacture of an MCB compliant with U.S. FDA standards」
The SHED MCB and stable supply system progressed from completion of the domestic MCB to completion of an MCB manufactured in compliance with U.S. FDA standards, in preparation for entering overseas markets. - FY2023-Q3Cited as achievedAnnual report
「The SHED master cell bank (MCB), which had been developed as the basis for commercializing SHED as a regenerative medicine product, was completed in August 2022. This enabled the Company to establish the integrated system (S-Quatre®) extending from collaboration with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital to obtain primary teeth as the source material for SHED manufacturing, through cell culture and GMP manufacturing of the MCB at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
The Company is reiterating the completion of the SHED master cell bank in August 2022 and the completed establishment of an integrated system covering source-material procurement through GMP manufacturing as achievements already attained. - FY2023-Q2AdvancedAnnual report
「The SHED master cell bank (MCB), which had been developed as the basis for commercializing SHED as a regenerative medicine product, was completed in August 2022. This enabled the Company to establish the integrated system (S-Quatre®) extending from collaboration with the “ChiVo Net Future Medicine Children’s Volunteer Network,” the University of Tokyo Hospital and Showa University Dental Hospital to obtain primary teeth as the source material for SHED manufacturing, through cell culture and GMP manufacturing of the MCB at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
The SHED master cell bank was completed in August 2022, and the Company progressed to the stage of establishing an integrated manufacturing system covering source-material procurement through GMP manufacturing. - FY2023-Q1AdvancedAnnual report
「We are conducting GMP manufacturing of the MCB at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd. and proceeding with the final quality inspection tests toward completion.」
MCB manufacturing with Nikon Cell Innovation progressed to the stage of conducting GMP manufacturing and proceeding with final quality inspection tests toward completion. - FY2022-Q3RestatedAnnual report
「As the necessary preparations have now been completed, we have commenced manufacture of the master cell bank at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
Even after commencing master cell bank manufacturing at the GMP/GCTP-compliant facility with Nikon Cell Innovation, the Company continues to build a manufacturing system aimed at commercializing SHED as a regenerative medicine product. - FY2022-Q2AdvancedAnnual report
「As the necessary preparations have now been completed, we have commenced manufacture of the master cell bank at the GMP/GCTP-compliant manufacturing facility of Nikon Cell Innovation Co., Ltd.」
The system for manufacturing the MCB and other materials with Nikon Cell Innovation progressed from the preparation stage to the commencement of master cell bank manufacturing at a GMP/GCTP-compliant facility. - FY2022-Q1RestatedAnnual report
「As an important step toward advancing its regenerative medicine business, the Company is proceeding with Nikon Cell Innovation Co., Ltd. to manufacture the master cell bank (MCB) and other materials that will form the basis for commercializing SHED as a regenerative medicine product」
The Company is continuing MCB and other manufacturing with Nikon Cell Innovation as an important step toward commercializing SHED as a regenerative medicine product. - FY2021-Q3First statedAnnual report
「In addition, as an important step toward advancing its regenerative medicine business, the Company is proceeding with Nikon Cell Innovation Co., Ltd. to manufacture the master cell bank (MCB), establish the working cell bank and build a stable supply system, all of which will form the basis for commercializing dental pulp stem cells as regenerative medicine products」
The Company first provided specific details of its efforts with Nikon Cell Innovation to manufacture the master cell bank for dental pulp stem cells, establish the working cell bank and build a stable supply system.