CiRA Foundation

What CiRA Foundation does

CiRA Foundation (公益財団法人 京都大学iPS細胞研究財団) is a public interest incorporated foundation established in April 2020 as a spin-off from Kyoto University's Center for iPS Cell Research and Application (CiRA), led by Nobel Laureate Shinya Yamanaka. The foundation manufactures, quality-controls, cryopreserves, and distributes clinical-grade and research-grade induced pluripotent stem (iPS) cells to academic institutions and commercial entities at affordable prices, alongside providing contract quality evaluation testing (whole genome sequencing, RNA sequencing, flow cytometry, methylation arrays), contract cell manufacturing, and regulatory/SOP consulting services.

Its core technology portfolio includes proprietary HLA homozygous and HLA genome-edited (CRISPR-Cas9) iPS cell stocks, a patent-registered closed-system counterflow centrifugation manufacturing method, the automated my iPS Kit culture system (developed with ITOCHU), and joint automated expansion workflows with Terumo using the Quantum Flex system. The foundation operates two licensed facilities: FiT (Facility for iPS Cell Therapy) in Kyoto (holding dual regenerative medicine cell processing and PMD Act manufacturing permits) and Y-FiT (Yanai Facility for my iPS Cell Therapy) in Osaka, funded by Tadashi Yanai's 4.5 billion yen donation. Its iPS cell stocks have been deployed in over 15 clinical research and trial projects and underpinned the world's first iPS cell-based regenerative medicine product approvals in Japan (ReHeart and Amchepry, March 2026).

The foundation operates a hybrid nonprofit revenue model combining low-margin cell provision (50,000–100,000 yen per line for for-profits, free for academia), one-time ownership transfer fees (50 million yen per product, half for ventures), long-tail royalties (0.5% of worldwide sales for 20 years post-approval), fee-for-service quality testing and contract manufacturing, SOP licensing, philanthropic donations (notably from Tadashi Yanai and Stephen A. Schwarzman), and government grants (AMED). It serves two primary customer segments: academic research institutions (60+ globally, receiving free or subsidized cells) and for-profit regenerative medicine and pharmaceutical companies (Sumitomo Pharma, Cuorips, Takeda, Heartseed, Mayo Clinic, and others) developing commercial iPS cell-based therapies.

Name

CiRA Foundation

Legal name

CiRA Foundation (公益財団法人京都大学iPS細胞研究財団)

Website

https://cira-foundation.or.jp

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

CiRA Foundation is a Kyoto-based nonprofit public interest foundation, spun out of Kyoto University CiRA, that manufactures and distributes clinical-grade iPS cell stocks and related services to academic institutions and regenerative medicine companies worldwide at affordable prices.

Ownership category

akta.pro rank

Product category

Regenerative Medicine iPS Cell Manufacturing and Supply

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Other Scientific and Technical Consulting Services (54169)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Data Management, Reporting & Regulatory Submissions for Central Labs (HLAGAEAL), Gene Therapy CMC/Process Development Platforms (capsid engineering, producer cell lines, plasmids, upstream/downstream) (HLAAACAN)

Keywords

• IPS cell manufacturing
• Regenerative medicine cells
• Stem cell banking
• Cell therapy materials
• Biotechnology research services

Headquarters

HQ city

Kyoto

HQ country

Japan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. iPS Cell Provision (Research-Grade): Research-grade iPS cells provided at an initial cost of 50,000 yen per line as a joint research fee to for-profit companies. Free to non-profit/academic institutions. Cells are not sold outright; recipients must enter collaborative research agreements.
2. iPS Cell Provision (Clinical-Grade): Clinical-grade iPS cells provided at an initial cost of 100,000 yen per line as a joint research fee to for-profit companies. Ownership transfer fee of 50 million yen at approval (half for ventures), plus an information maintenance fee of 0.5% of worldwide sales for 20 years from the year following approval.
3. Quality Evaluation Testing Services: Entrusted quality evaluation testing services for iPS cells, including plasmid residue testing, whole genome sequencing, exome sequencing, SNP array analysis, bulk RNA sequencing, single-cell sequencing, methylation array analysis, flow cytometry for undifferentiated marker expression, and library sequencing.
4. Cell Contract Manufacturing Services: Contract manufacturing of clinical-grade iPS cells and differentiated cells, plus cell cryopreservation storage and dispatch services.
5. SOP Provision: Standard Operating Procedures for cell processing facility operations, equipment maintenance and inspection, and manufacturing and quality testing methods are available for purchase at 150,000 yen per SOP in PDF format with a two-week download period.
6. Philanthropic Donations: The foundation accepts donations from individuals and organizations. Stephen A. Schwarzman provided approximately 380 million yen ($2.5 million) in philanthropic support from FY2025 to FY2027 for cancer therapy research using iPS cells.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

CiRA Foundation manufactures and provides clinical-grade and research-grade human induced Pluripotent Stem (iPS) cells to academic research institutions and for-profit companies, along with quality evaluation testing services (genome/RNA sequencing, methylation arrays, flow cytometry), contract manufacturing and cryopreservation of clinical-grade iPS and differentiated cells, SOP documentation licensing, and regulatory/IP consulting. Cells are distributed through a Stock Committee approval process as joint research rather than being sold outright, with separate pricing for non-profit (free) and for-profit recipients plus ownership transfer and royalty fees upon commercial product approval.

Product overview

CiRA Foundation operates two core projects: the iPS Cell Stock Project, which manufactures and provides clinical-grade iPS cells with rigorous quality control at affordable prices to research institutions and companies, and the my iPS Project, which develops the my iPS Kit, a closed-system automated culture kit to automate and reduce costs of patient-specific iPS cell production. The foundation provides a comprehensive product portfolio including various iPS cell types (HLA homozygous, HLA genome-edited using CRISPR-Cas9, SeV-based), research materials (CFiS Series), and extensive services including quality evaluation testing (genome sequencing, RNA sequencing, flow cytometry), cell contract manufacturing, SOP provision, and regulatory consulting. Major facilities include FiT for clinical-grade iPS cell manufacturing and Y-FiT for the my iPS Project, both licensed under Japanese regenerative medicine regulations.

Differentiator

Problem solved

Functional benefit

Brands

• iPS Cell Stock Project: A project that manufactures iPS cells from somatic cells donated by healthy volunteers at the Facility for iPS Cell Therapy (FiT) and provides clinical-grade iPS cells after rigorous quality control.
• my iPS Project
• my iPS Kit

Products and services

• Clinical-grade iPS Cells Clinical-grade iPS cell lines meeting clinical-use standards, cryopreserved and supplied as raw material for transplant cells, including HLA homozygous, HLA genome-edited, and SeV (Sendai virus) iPS cell variants. Distributed through the Stock Committee application system to academic and commercial partners.
• HLA Homozygous iPS Cells iPS cells derived from HLA-homozygous donors that reduce immune rejection risk in regenerative medicine applications, available from umbilical cord blood and peripheral blood sources. Sold/provided as clinical-grade raw material through joint research agreements.
• HLA Genome-edited iPS Cells Clinical-grade iPS cells generated using CRISPR-Cas9 genome editing, with HLA-A, HLA-B, and CIITA genes deleted and HLA-C retained to reduce immune rejection risk; available from umbilical cord blood and peripheral blood sources.
• SeV (Sendai virus) iPS Cells iPS cells generated using Sendai virus (SeV) technology for reprogramming somatic cells, available as clinical-grade raw material.
• CFiS Series Research-Grade iPS Cells Research-grade iPS cell lines provided at low cost to academic and non-profit institutions for non-clinical basic research use.
• Quality Evaluation Testing Services Comprehensive quality testing services for iPS cells including plasmid residue testing, whole genome sequencing, exome sequencing, SNP arrays, bulk and single-cell RNA sequencing, methylation arrays, flow cytometry for undifferentiated marker expression, and library sequencing. Performed for both academic and commercial clients.
• Clinical-grade Cell Manufacturing and Cryopreservation Services Contract manufacturing of clinical-grade iPS cells and differentiated cells, plus cell cryopreservation, storage, and dispatch services offered to academic and commercial clients.
• my iPS Kit (Closed-system Automated Culture Kit) Closed-system automated culture kit for iPS cell production developed through the my iPS Project; keeps cells isolated from the external environment throughout cultivation, drastically reducing manufacturing cost versus manual production. Co-developed with ITOCHU Corporation.
• Standard Operating Procedures (SOP) Distribution SOP documentation covering cell processing facility operation, equipment maintenance and inspection, and manufacturing and quality testing methods. Sold as PDF files at ¥150,000 per SOP with a two-week download period for use by regenerative medicine developers.
• Regulatory and IP Consulting Services Intellectual property and contract support, regulatory and clinical development consulting services to support companies and institutions in advancing iPS cell-based regenerative therapies.
• FiT (Facility for iPS Cell Therapy) Manufacturing and Quality Testing Service Dedicated cell processing facility holding the 再生医療等の安全性の確保等法 cell processing facility permit (FA5200001) and PMD Act manufacturing license (26FZ110001), providing manufacturing and quality testing of clinical-grade iPS cells for client institutions and companies.

Quantifiable outcome

• iPS cells have been used in more than 10 clinical trials globally, including in the United States
• +3 more outcomes

Named customers15 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature5 records

Partnerships

Five partnerships are on record, tiered minor, core and flagship.

• Matricelf Ltd.minorStrategic or Co-development Partner · 30 March 2026Matricelf, an Israeli biotech developing autologous engineered neural tissue therapy for spinal cord injury, entered a collaborative research agreement with CiRA Foundation. CiRA Foundation supplies iPSCs from 3 healthy donors for Matricelf to assess integration with its proprietary hydrogel platform. The goal is to develop an automated, large-scale manufacturing process for engineered neural tissues, with predefined success criteria including neural marker expression and functional electrical activity.
• Terumo Corporation / Terumo Blood and Cell TechnologiescoreStrategic or Co-development Partner · 5 March 2026Terumo and CiRA Foundation were selected for AMED funding to jointly develop automated and standardized workflows for iPS cell manufacturing. The collaboration uses Terumo's Quantum Flex Cell Expansion System and tests new protocols at CiRA Foundation's FiT facility. The two organizations are also co-developing monitoring software to enable real-time tracking of culture media conditions, aiming to reduce operator-dependent variability and lower production costs. This builds on a 2024 partnership for automated iPS cell manufacturing development.
• One GenomicscoreStrategic or Co-development Partner · 8 January 2026One Genomics and CiRA Foundation announced a strategic research collaboration to advance precision genome engineering technologies. One Genomics contributes its high-precision, fine-tunable CRISPR design platform including Safeguard approach, while CiRA Foundation applies these technologies in human iPS cells. The collaboration aims to address limitations of conventional genome engineering including off-target mutations and bystander effects, enabling greater precision and controllability for cellular and clinical applications.
• ITOCHU CorporationcoreStrategic or Co-development Partner · 24 April 2025ITOCHU and CiRA Foundation signed a basic agreement to support the development and licensing of the 'my iPS Kit,' a closed-system automated culture kit for iPS cell production. Leveraging ITOCHU's expertise in chemicals, the partnership focuses on optimal raw material selection and sterilization technology development. ITOCHU has been supporting the my iPS Project since before the agreement to advance materials development for greater safety and efficiency.
• Mayo Clinic (Center for Regenerative Biotherapeutics)flagshipStrategic or Co-development Partner · 22 February 2025Mayo Clinic and CiRA Foundation signed an iPS Cell Stock Collaboration Agreement allowing Mayo Clinic to expand, culture, and store CiRA Foundation's research-grade iPS cells for distribution to its 11 research groups. This enables ready distribution of iPS cells in the U.S. while avoiding the risk and expense of transporting iPS cells internationally. The agreement was formalized in a virtual signing ceremony on February 22, 2025.

Scale indicators8 records

Recent moves8 records

Expansion highlights7 records

Direct peers

• Cuorips Inc. Cuorips is a Japan-based clinical-stage company that developed ReHeart (human allogeneic iPS cell-derived cardiomyocyte sheet), which received the world's first conditional iPS cell-based product approval in March 2026. It is a customer of CiRA Foundation but also a direct peer in iPSC-derived cardiac regenerative medicine.
• Century Therapeutics: Century Therapeutics develops allogeneic iPSC-derived cell therapies engineered with multiple next-generation features to prevent immune rejection. It is a direct competitor to CiRA Foundation's HLA genome-edited iPS cell approach, both targeting immune-compatible off-the-shelf cell therapy raw materials.
• Cynata Therapeutics: Cynata Therapeutics is an Australian clinical-stage company developing iPSC-derived mesenchymal stem cell (MSC) therapies. Its Cymerus platform uses iPS cells as starting material for MSC production, making it a direct peer in the iPSC-derived therapeutic manufacturing space.
• Heartseed Inc. Heartseed is a Japan-based clinical-stage company developing iPSC-derived cardiomyocyte therapies for heart failure. It is both a CiRA Foundation customer and a direct peer developing iPSC-derived cardiac regenerative medicines, paralleling Cuorips' ReHeart program.
• BlueRock Therapeutics: BlueRock Therapeutics (acquired by Bayer) develops iPSC-derived cell therapies, including dopaminergic neuron therapies for Parkinson's disease. It is a direct iPSC-derived therapeutic developer competing with CiRA Foundation's pharma customers (e.g., Sumitomo's Amchepry) for similar regenerative medicine indications.
• Fate Therapeutics: Fate Therapeutics is a U.S.-based clinical-stage biopharmaceutical company developing iPSC-derived cell therapies including NK and T cell cancer immunotherapies. It is one of the leading developers of off-the-shelf iPSC-derived allogeneic cell therapies, making it the most directly comparable for-profit counterpart to CiRA Foundation's iPS cell stock platform.

Broad incumbents

• Kyoto University CiRA (Center for iPS Cell Research and Application): Kyoto University's CiRA is the parent academic research center from which CiRA Foundation was spun off in 2020. It conducts basic and applied iPS cell research, including the original Yamanaka lab work, and is the broad incumbent in academic iPS cell research that the foundation commercializes and scales.
• Sumitomo Pharma Co., Ltd. Sumitomo Pharma is a major Japanese pharmaceutical company that developed Amchepry (iPSC-derived Parkinson's therapy) using CiRA Foundation's cells. While not exclusively focused on iPS cell therapy, its commercial-scale iPSC product development represents a broader-incumbent peer leveraging CiRA's platform.

Regional players

• Cell and Gene Therapy Catapult: Cell and Gene Therapy Catapult is a UK-based cell and gene therapy accelerator that has an established collaborative research partnership with CiRA Foundation. It serves an analogous bridging role between academia and industry in the UK/European market, making it a regional comparable.

Others

• California Institute for Regenerative Medicine (CIRM): CIRM is the California state agency funding stem cell research, including iPSC-derived therapies. It is an adjacent ecosystem participant rather than a direct competitor, but parallels CiRA Foundation's mission of advancing regenerative medicine through public-interest funding and infrastructure support.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/CiRA_F_J
• YouTubeyoutube.com/channel/UCjULoS139NIxvKMUYmGl8Qg
• Facebookfacebook.com/CiRAF.iPS
• LinkedInlinkedin.com/company/cira-foundation

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about CiRA Foundation