Mass Production of Allogeneic Regenerative Cell Therapies and Securing Product Supply Rights
First written in FY2017. 17 of 20 entries say "Advanced", first in FY2020-Q1. Latest entry: 2026-09-17.
2 other companies' latest entry also says "Advanced".
- 2026-09-17AdvancedResults presentation
「ミナリス米国マウンテンビュー工場の閉鎖に伴い、上流工程を国内に移管 日本ミナリス社横浜工場での国内一貫製造体制の構築」
ミナリス米国工場の閉鎖に伴う上流工程の国内移管と、日本ミナリス社横浜工場での国内一貫製造体制の構築が示され、アクーゴ®の商用製造・安定供給に向けた体制整備が具体化した。 - FY2027-H1AdvancedAnnual report
「Following the start of sales, we are providing information to healthcare professionals through lectures and other activities to promote the proper use of Acugo® and are building a stable supply system.」
Following the launch of Acurago®, the Company advanced to the stage of providing information to healthcare professionals through lectures and other activities and establishing a stable supply system. - FY2026AdvancedAnnual report
「Regarding logistics, the Company has worked to establish a stable supply system, including the introduction of the R-SAT® system, a distribution management system jointly developed with SUZUKEN CO.,LTD. to ensure reliable delivery of Acurago® to patients under strict quality control.」
To ensure a stable supply of Acurago®, the Company introduced the R-SAT® system jointly developed with SUZUKEN CO.,LTD., and preparations progressed for the first shipment in the following consolidated fiscal year. - FY2026-H1AdvancedAnnual report
「Subsequently, manufacturing was conducted to obtain conformity for approximately 2 commercial-scale production runs to confirm comparability and consistency, one of the approval conditions. The 2 production runs completed to date have met all acceptance criteria in specification testing and characterization and have been judged to conform. In response, in June 2025 we completed an application for partial changes to the marketing authorization particulars for Akuugo®.」
Preparations for the commercial supply of Acurago® advanced with the completion of 2 successful commercial product manufacturing runs and the completion of the application for approval of a partial change to the marketing authorization. - FY2025AdvancedAnnual report
「In January 2025, the Company entered into a manufacturing outsourcing agreement with JCR Pharmaceuticals Co., Ltd. covering trial manufacturing to examine commercial production of Acurago®. This made it possible to consider stabilizing and diversifying product supply, both for stable production of commercial Acurago® products and in anticipation of expanding indications, including cerebral infarction, and expanding into the U.S. market.」
To examine commercial production of Acurago®, the Company entered into a manufacturing outsourcing agreement with JCR Pharmaceuticals for trial manufacturing, advancing to the stage at which it can consider stabilizing and diversifying supply. - FY2025-H1AdvancedAnnual report
「The Company plans to conduct approximately 2 rounds of commercial product manufacturing promptly, confirm equivalence and comparability, which are among the approval conditions, and work toward being ready to ship in the first quarter of the fiscal year ending January 2026 (February-April 2025).」
The Company outlined a plan to conduct approximately 2 rounds of commercial product manufacturing and confirm equivalence and comparability after conditional approval, with the aim of being ready to ship in the first quarter of the fiscal year ending January 2026. - FY2024AdvancedAnnual report
「Total capital expenditures during the consolidated fiscal year amounted to ¥54 million, primarily for software and other systems used in post-marketing studies.」
The Company made ¥54 million in capital expenditures to develop systems for post-marketing operations. - FY2023AdvancedAnnual report
「Total capital expenditures during the consolidated fiscal year amounted to ¥9 million, primarily for equipment at the Company's facilities used for packaging, labeling and storage of regenerative medicine products.」
To ensure a stable supply of SB623, the Company invested in equipment at its own facilities for packaging, labeling and storage of regenerative medicine products, and obtained a domestic manufacturing license for packaging, labeling and storage in December 2022. - FY2023-Q3AdvancedAnnual report
「Establishment of a manufacturing system and inventory procurement after the launch of the SB623 chronic traumatic brain injury program: 6,846; November 2022-November 2024」
The use of ¥6,846 million in proceeds from the 34th Series Stock Acquisition Rights to establish a post-marketing manufacturing system and secure inventory for SB623, together with the planned spending period through November 2024, has been specified. - FY2022AdvancedAnnual report
「The Company will continue to establish a stable supply system, including the joint development with SUZUKEN CO.,LTD. of the R-SAT system, a distribution management system designed to ensure reliable delivery of products to patients under strict quality control. It will also work to establish a system promoting appropriate use, including the preparation of materials providing product information to medical institutions, development of a system for distributing those materials, and development of a patient eligibility assessment system.」
In addition to ensuring a stable supply of SB623, the scope of the post-approval appropriate-use framework has become more specific, including information provision for medical institutions and a patient eligibility assessment system. - FY2020-Q3RestatedAnnual report
「The funds are scheduled to be used to diversify the contract manufacturing companies and secure SB623 inventory in order to increase SB623's mass-production capacity and establish a stable supply system. The inventory is initially scheduled to be sold for use in chronic traumatic brain injury in Japan.」
The policy of ensuring a stable supply by increasing SB623's mass-production capacity, diversifying contract manufacturers and securing inventory has been reaffirmed. - FY2020-Q1AdvancedAnnual report
「This fundraising was undertaken in anticipation of demand for SB623 sales in Japan, the United States and Europe. The funds are scheduled to be used to diversify the contract manufacturing companies and secure SB623 inventory in order to increase SB623's mass-production capacity and establish a stable supply system. The inventory is initially scheduled to be sold for use in chronic traumatic brain injury in Japan.」
Specific measures to increase mass-production capacity and ensure a stable supply, including diversification of contract manufacturers and inventory procurement, were outlined, along with preparations to supply the product for chronic traumatic brain injury in Japan. - FY2019RestatedAnnual report
「The Company has established technology for large-scale culturing of donor bone marrow fluid, manufacturing homogeneous products, cryopreserving and transporting them, and thawing and administering them. It has reached the stage at which it can support mass production after product sales begin.」
The technology for supporting mass production through large-scale culturing, cryopreservation, transport and administration of allogeneic cells has been reaffirmed. - FY2017First statedAnnual report
「The Company has established technology for large-scale culturing of donor bone marrow fluid, manufacturing homogeneous products, cryopreserving and transporting them, and thawing and administering them. It has reached the stage at which it can support mass production after product sales begin.」
The Company has established technology for large-scale culturing, cryopreservation and supply of allogeneic cells, and explains that it has reached the stage at which it can support mass production after product sales begin.