{"id":519,"date":"2025-12-16T14:00:00","date_gmt":"2025-12-16T05:00:00","guid":{"rendered":"https:\/\/cellfiber.jp\/en\/?p=519"},"modified":"2026-01-09T09:54:19","modified_gmt":"2026-01-09T00:54:19","slug":"20251216_pressrelease_new-extruder","status":"publish","type":"post","link":"https:\/\/cellfiber.jp\/en\/20251216_pressrelease_new-extruder\/","title":{"rendered":"\u3010PRESS RELEASE\u3011CellFiber Unveils New GMP-Compliant Cell Fiber Fabrication System&#8221;CellFiber Extruder&#8221; for Regenerative Medicine \uff5eEnabling Efficient and Stable Manufacturing of Cell Therapy Products\uff5e"},"content":{"rendered":"\n<p>Tokyo, Japan \u2014 December 16, 2025\u202f\u2014<br>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 &#8220;CellFiber Extruder&#8221;. The system enables large-scale, high-quality cell manufacturing for regenerative medicine and advanced cell therapy products.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"591\" height=\"1024\" src=\"https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-591x1024.jpg\" alt=\"\" class=\"wp-image-520\" style=\"width:357px\" srcset=\"https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-591x1024.jpg 591w, https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-173x300.jpg 173w, https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-768x1330.jpg 768w, https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-887x1536.jpg 887w, https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-1182x2048.jpg 1182w, https:\/\/cellfiber.jp\/en\/wp-content\/uploads\/2025\/12\/Photo_CellFiber-Extruder-scaled.jpg 1478w\" sizes=\"auto, (max-width: 591px) 100vw, 591px\" \/><\/figure>\n<\/div>\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p><strong>\u25a0Message from Kazuchika Furuishi, Representative Director, CEO<\/strong><br>CellFiber has advanced product development with an unwavering mission: to commercialize Japan&#8217;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 &#8211; 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.<br>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.<\/p>\n\n\n\n<p><strong>\u25c6About CellFiber\u00ae Technology<\/strong><br>CellFiber\u00ae 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\u00ae technology demonstrates enhanced functional maintenance, long-term viability, and greater consistency compared to conventional methods. As a result, CellFiber\u00ae is emerging as a next-generation platform for efficient, high-quality cell manufacturing.<\/p>\n\n\n\n<p><strong>\u25c6About CellFiber Extruder<\/strong><br>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:<\/p>\n\n\n\n<p><strong>\uff1cKey Benefits\uff1e<br>Automation<\/strong><br>Streamlines cell fiber production for large-scale cultures, significantly reducing manufacturing time.<\/p>\n\n\n\n<p><strong>Flexibility<\/strong><br>Compatible with a wide range of applications, including suspension and adherent cell cultures, upstream and downstream processes, and multiple types of culture vessels.<\/p>\n\n\n\n<p><strong>Closed System<\/strong><br>Utilizes a single-use kit to minimize contamination risks from manual handling or the surrounding work environment.<\/p>\n\n\n\n<p><strong>Traceability<\/strong><br>Equipped with compliance features such as monitoring logs, access control, and audit trails to support regulatory requirements.<\/p>\n\n\n\n<p><strong>\uff1cProduct Specifications\uff1e<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>User Interface<\/td><td>Equipped with a color LCD touchscreen featuring an intuitive graphical user interface (GUI) for easy, straightforward operation.<\/td><\/tr><tr><td>Dimensions<\/td><td>W: 699 mm \u00d7 D: 565 mm \u00d7 H: 1380 mm (27.5\u201d \u00d7 22.2\u201d \u00d7 54.3\u201d)&nbsp;<\/td><\/tr><tr><td>Weight<\/td><td>128 kg (282.2 lb)&nbsp;<\/td><\/tr><tr><td>Power Requirements<\/td><td>95-125 VAC, 50\/60 Hz, 200VA<\/td><\/tr><tr><td>Built-in PC OS<\/td><td>Built-in computer equipped with Windows 10<\/td><\/tr><tr><td>Connectivity<\/td><td>1 USB slot, 1 Ethernet port<\/td><\/tr><tr><td>Regulatory Compliance<\/td><td>GAMP5, 21 CFR Part 11<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><br><strong>\uff1cEquipment\uff1e<\/strong><br><strong>\u30fbSingle-use kit and reagent set<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Name<\/td><td>Overview<\/td><\/tr><tr><td>Extruder single-use kit<\/td><td>\u30fbDesigned for use with the extruder system.<br>\u30fbEquipped with a sterile connector for aseptic connection with reagents.<br>\u30fbFinal line made of compatible materials for connecting culture bags using sterile connectors.<\/td><\/tr><tr><td>\u30fbReagent kit for adherent cell culture<br>\u30fbReagent kit for suspension cell culture<\/td><td>Designed for a 5-liter scale culture.<br>Target yield:<br>\u3000\u30fbAdherent cells: 10<sup>9<\/sup> cells per set<br>\u3000\u30fbSuspension cells: 10<sup>10<\/sup> cells per set<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u203bThe CellFiber Extruder Single Use System meets the following standards:<br>\u3000\u30fbUSP 1043, ISO 20399:2022<br>\u3000\u30fbSterilization-related: ISO 11137<\/p>\n\n\n\n<p><strong>About CellFiber Co., Ltd.<\/strong><br>CellFiber is a biotechnology company built on our proprietary cell encapsulation technology called &#8220;CellFiber\u00ae&#8221;. \u201cCell Culture Reimagined for Life\u201d &#8211; CellFiber is dedicated to advancing cell manufacturing technologies to make cell and gene therapies more widely accessible and ultimately improve patients\u2019 quality of life.<br><strong>\uff1cCompany Profile\uff1e<\/strong><br>Company name: CellFiber Inc.<br>Head office: MSC Fukagawa Building No. 2, Room 105, 2-9-8 Saga, Koto-ku, Tokyo 135-0031, Japan<br>Representative: Representative Director, CEO Kazuchika Furuishi<br>Date of establishment: April 1, 2015<br>Business Description: Research, development, production, and sales of biomaterials and soft materials containing living cells (MAP)<br>URL: <a href=\"https:\/\/cellfiber.jp\/en\/\">https:\/\/cellfiber.jp\/en\/<\/a><\/p>\n\n\n\n<p><strong>MEDIA CONTACT<\/strong><br>Email: cellfiber@storieson.co.jp<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tokyo, Japan \u2014 December 16, 2025\u202f\u2014CellFiber 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 &#8220;CellFiber Extruder&#8221;. The system enables large-scale, high-quality cell manufacturing for regenerative medicine and advanced cell therapy products. Cell therapies, such as CAR-T and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":true,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,1],"tags":[],"class_list":["post-519","post","type-post","status-publish","format-standard","hentry","category-press-release","category-all"],"_links":{"self":[{"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/posts\/519","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/comments?post=519"}],"version-history":[{"count":3,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/posts\/519\/revisions"}],"predecessor-version":[{"id":543,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/posts\/519\/revisions\/543"}],"wp:attachment":[{"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/media?parent=519"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/categories?post=519"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cellfiber.jp\/en\/wp-json\/wp\/v2\/tags?post=519"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}