JP
Tokyo, Japan — December 16, 2025 —
CellFiber Co., Ltd., a biotech company pioneering next-generation cell culture technology, has announced the introduction of the production-scaled model of its GMP-compliant cell fiber fabrication system, the “CellFiber Extruder”. The system enables large-scale, high-quality cell manufacturing for regenerative medicine and advanced cell therapy products.
Cell therapies, such as CAR-T and iPSC-derived therapies, continue to gain global attention for their transformative therapeutic potential. Yet widespread patient access remains limited due to manufacturing complexity, long production timelines, and high cost. Scalable, cost-efficient cell culture technologies have been a significant unmet need for the industrialization of cell therapeutics.
The CellFiber Extruder addresses these challenges by enabling GMP-compliant, large-scale cell fiber fabrication with stable, standardized, and streamlined processes. The system supports mass production by reducing overall manufacturing time while simultaneously enhancing cell function through optimized culture conditions. CellFiber will continue advancing product development and work toward establishing a full-scale, industrialized cell manufacturing platform.
This system has been developed with support from the Japan Agency for Medical Research and Development (AMED) under the Venture Innovation and Cultivation Leading Environment (ViCLE) program since 2023, and from the New Energy and Industrial Technology Development Organization (NEDO) through the Deep Tech Startup Support Fund/Deep Tech Startup Support Program.
■Message from Kazuchika Furuishi, Representative Director, CEO
CellFiber has advanced product development with an unwavering mission: to commercialize Japan’s innovative cell culture technology globally and unlock the scalability required for the widespread adoption of cell therapy. We see a significant market opportunity ahead. As regenerative medicine and cell therapy continue their rapid expansion, the industry faces a critical bottleneck – cost-efficient, industrial-scale manufacturing of high-quality cells. This remains one of the most valuable and underserved segments in the advanced therapy value chain. We are confident that our cell fiber technology offers a truly differentiated solution by enabling high-quality, cost-effective, and scalable cell culture. These capabilities directly address the key constraints limiting commercialization of cell-based therapeutics and position of CellFiber as a strategic partner for pharmaceutical companies and CDMOs worldwide.
With the introduction of our GMP-compliant mass-production model for the CellFiber Extruder, we are entering a phase of global deployment. Our objective is to establish CellFiber as a core manufacturing technology platform in Japan and internationally, supporting the industrialization of cell therapy and creating a more efficient and accessible market.
◆About CellFiber® Technology
CellFiber® technology is an encapsulation technology that protects cells within a tubular structure made of medical-grade alginate, providing a secure, biomimetic environment for high-density cell culture. CellFiber® technology demonstrates enhanced functional maintenance, long-term viability, and greater consistency compared to conventional methods. As a result, CellFiber® is emerging as a next-generation platform for efficient, high-quality cell manufacturing.
◆About CellFiber Extruder
The CellFiber Extruder is designed for GMP-compliant cell fiber fabrication, directly encapsulating cells into culture bags. Equipped with a dedicated single-use kit and reagent set, the Extruder system offers several benefits:
＜Key Benefits＞
Automation
Streamlines cell fiber production for large-scale cultures, significantly reducing manufacturing time.
Flexibility
Compatible with a wide range of applications, including suspension and adherent cell cultures, upstream and downstream processes, and multiple types of culture vessels.
Closed System
Utilizes a single-use kit to minimize contamination risks from manual handling or the surrounding work environment.
Traceability
Equipped with compliance features such as monitoring logs, access control, and audit trails to support regulatory requirements.
＜Product Specifications＞
| User Interface | Equipped with a color LCD touchscreen featuring an intuitive graphical user interface (GUI) for easy, straightforward operation. |
| Dimensions | W: 699 mm × D: 565 mm × H: 1380 mm (27.5” × 22.2” × 54.3”) |
| Weight | 128 kg (282.2 lb) |
| Power Requirements | 95-125 VAC, 50/60 Hz, 200VA |
| Built-in PC OS | Built-in computer equipped with Windows 10 |
| Connectivity | 1 USB slot, 1 Ethernet port |
| Regulatory Compliance | GAMP5, 21 CFR Part 11 |
＜Equipment＞
・Single-use kit and reagent set
| Name | Overview |
| Extruder single-use kit | ・Designed for use with the extruder system. ・Equipped with a sterile connector for aseptic connection with reagents. ・Final line made of compatible materials for connecting culture bags using sterile connectors. |
| ・Reagent kit for adherent cell culture ・Reagent kit for suspension cell culture | Designed for a 5-liter scale culture. Target yield: ・Adherent cells: 109 cells per set ・Suspension cells: 1010 cells per set |
※The CellFiber Extruder Single Use System meets the following standards:
・USP 1043, ISO 20399:2022
・Sterilization-related: ISO 11137
About CellFiber Co., Ltd.
CellFiber is a biotechnology company built on our proprietary cell encapsulation technology called “CellFiber®”. “Cell Culture Reimagined for Life” – CellFiber is dedicated to advancing cell manufacturing technologies to make cell and gene therapies more widely accessible and ultimately improve patients’ quality of life.
＜Company Profile＞
Company name: CellFiber Inc.
Head office: MSC Fukagawa Building No. 2, Room 105, 2-9-8 Saga, Koto-ku, Tokyo 135-0031, Japan
Representative: Representative Director, CEO Kazuchika Furuishi
Date of establishment: April 1, 2015
Business Description: Research, development, production, and sales of biomaterials and soft materials containing living cells (MAP)
URL: https://cellfiber.jp/en/
MEDIA CONTACT
Email: cellfiber@storieson.co.jp
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