Cellfiber Selected for AMED CiCLE Project (ViCLE Innovation Creation Environment Development Type) – Accelerating development of cell medicine mass production technology and establishment of bases –

cell fiber
Cellfiber Selected for AMED CiCLE Project (ViCLE Innovation Creation Environment Development Type) – Accelerate development of mass production technology for cell medicines and establishment of bases – Cell fiber, Inc., a startup that develops cell mass production technology, has been selected for the AMED CiCLE project, and has decided to receive a subsidy of approximately 800 million yen for cell manufacturing technology development and base maintenance costs.
Cell fiber Co., Ltd. (Head office: Koto-ku, Tokyo, CEO: Tasuku Yanagisawa, Aki Adachi, hereinafter referred to as “Cell fiber”), a cell mass production technology development startup, is a national research and development agency Japan Agency for Medical Research and Development (AMED) Reiwa Adopted for the 4th fiscal year “Medical Research and Development Innovation Platform Creation Project (CiCLE)”, it was decided to receive a subsidy of about 800 million yen for the development of cell manufacturing technology and the cost of establishing a base. In this project, we will develop a technology that can manufacture 10 11 cells per batch at pharmaceutical grade, which is the manufacturing scale required for the spread of cell therapy. In addition, we will develop a process development base to solve scale-up issues in cell medicine manufacturing.
Dear members of the press,
《November 11, 2022》
Cell Fiber Co., Ltd.
Cell fiber Co., Ltd. (Head office: Koto-ku, Tokyo, CEO: Tasuku Yanagisawa, Aki Adachi, hereinafter referred to as “Cell fiber”), a cell mass production technology development startup, is a national research and development agency Japan Agency for Medical Research and Development (AMED) Reiwa We were selected for the 4th fiscal year “Medical Research and Development Innovation Platform Creation Project (CiCLE)” and decided to receive a subsidy of approximately 800 million yen for cell manufacturing technology development and base maintenance costs.
In this project, we will develop technology that can manufacture 10 to the 11th power of cells per batch, which is the manufacturing scale required for the spread of cell therapy (*1). In addition, in accordance with the purpose of the business, we will establish a process development base to solve the issue of scaling up in the manufacturing of cell medicines.
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■ Background
As an epoch-making treatment for cancer and other diseases and disorders, “cell medicine”, which is expected to have a therapeutic effect by administering the cells themselves, is attracting attention. In clinical trials of cell medicines, priority is given to phase I trials to verify safety and pharmacokinetics (*2), so cell
manufacturing methods are determined through small-scale experiments that are far from actual manufacturing. There are many cases. However, once a decision is made to change the manufacturing method, it can affect the quality of the cells, which is a high hurdle. . In fact, the drug price of cell medicines is extremely high at several tens of millions of yen per dose, and their application is currently limited to a very small number of patients.
■ Purpose of this project
Cellufiber aims to develop cell manufacturing technology that can be considered from the early stages of development of cell medicines and that has an eye on commercialization. By using Cell Fiber’s unique culture technology, Cell Fiber (described later), we aim to scale up the manufacturing process while ensuring cell quality, and to significantly reduce costs through mass production. The target production scale is 10 to the 11th power per batch, and production is possible in a closed system and under GMP (*3) grade. In addition, in order to spread the results of development to cell therapy, we will establish a process development base that can use CellFiber technology from the early stages of cell drug development, contributing to lowering the cost of treatment. Through these efforts, we aim to create a society in which cell therapy is a more accessible option. ■ About “cell fiber”
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Cell fiber technology is a technology that encloses and cultures cells in hollow hydrogel (*4) tubes that are as thin as a human hair. It provides a biomimetic microenvironment for the cells inside, protects them from mechanical stress, and enables easy scale-up culture. In addition, regardless of the scale of the culture, the environment around the cells can be kept constant, so high-quality cells can be cultured at high density, and the manufacturing process can be made more efficient. Using this technology, Cellfiber has already achieved production of up to 1010 cells per batch for multiple cell types, and has obtained PoC (*5) data suggesting qualitative equivalence and safety. It’s finish. In addition, GMP manufacturing equipment has been completed up to the prototype stage.
■ About cell fiber
Cell Fiber, a startup from the University of Tokyo, is working on the development of cell mass production technology using “cell fiber” technology in order to contribute to the spread of the cell industry, including medical care. While cell medicines are attracting attention mainly for regenerative medicine and cancer immunotherapy,
manufacturing processes that still rely on manual labor are still the mainstream, and the rationalization of manufacturing is an urgent issue. Cellufiber aims to realize a society in which everyone can afford cell therapy by realizing mass production of expensive cell medicines using its own culture technology.
(*1) Cell therapy: A medical method that aims to achieve a therapeutic effect on a disease or disorder by administering the cells themselves. (*2) Pharmacokinetics: Process from drug administration to excretion (*3) GMP: Abbreviation for Good Manufacturing Practice. “Good Manufacturing Practices” (manufacturing control and quality control standards) required of manufacturers and marketing authorization holders of pharmaceuticals, etc.
(*4) Hydrogel: A solid that absorbs water and swells, and itself lacks fluidity. Jelly, agar, highly absorbent
(*5) PoC: Abbreviation for Proof of Concept. To verify the feasibility of new ideas and concepts and the effects that can be obtained from them.
・About Cellfiber Co., Ltd.
・Date of establishment: April 1, 2015
・ Location: 〒135-0031 2-9-8 Saga, Koto-ku, Tokyo MSC Fukagawa Building No. 2 Building 107
・Representatives: Yu Yanagisawa, Aki Adachi
・Capital: 60,000,000 yen
・Business description: Development of mass cell culture solutions using cell fiber technology
・ Official website: https://cellfiber.jp/
Details about this release:
https://prtimes.jp/main/html/rd/p/000000015.000067783.html


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