July 30, 2021

Fujimori Kogyo Co., Ltd.

Achieving ultra-large-scale culture of iPS cells by using our proprietary cell culture technologies

A joint research team consisting of members from Fujimori Kogyo Co., Ltd. (Head Office: Bunkyo-ku, Tokyo, Representative Director and President: Eishi Fuyama, Brand name "ZACROS") and from Osaka University's Graduate School of Engineering, Techno Arena, Base for Cell Manufacturability (headed by Prof. Masahiro Kino-oka) was the first in the world (*1) to succeed in the culturing of human induced pluripotent stem (iPS) cells to 11 billion cells while maintaining cell pluripotency. This was achieved by utilizing ZACROS' "BioPhaS®" single-use products and the company's proprietary and innovative orbital-shaking bioreactor.

(*1 For aggregate culture of human iPS cells, according to our research, as of July 20, 2021.)

This research is one of the Japan Agency for Medical Research and Development (AMED)'s project "Research of scale-up based on cell manufacturability and the system development for human resource to impart manufacturing expertise." This is focused on developing key evaluation technology and manufacturing technology for industrialization in the field of regenerative medicine. It will contribute to establish large-scale manufacturing processes for the human iPS cells, that are necessary for the industrialization of regenerative medicine.

This project will be presented at a conference at the 34th Annual Meeting of the Japanese Association for Animal Cell Technology (JAACT, July 27-28 2021) as "Q-14 Development of Suspension Culture System for Large Scale Production of Human Stem Cells."

ZACROS is investing into capacity for the "BioPhaS®" single-use products, which are indispensable for the manufacturing of biologics and COVID-19 vaccines. This will utilize our value-added,long-held plastic film processing technologies.

In order to utilize and deploy these technologies and know-how in the fields of regenerative medicine and gene therapy, we have accumulated cell culture technologies for the purpose of developing our proprietary and innovative bioreactor. Based on these technologies, we have collaborated with academias and regenerative medicine ventures to develop culture processes for various cells such as human iPS cells and mesenchymal stem cells. We will move forward with further R&D and commercialization believing that the research and

development results obtained in this project will be indispensable for regenerative medicine and gene therapy industrialization and that these technologies will contribute to their future popularization.

Helping to shape a more comfortable society through the creation of value-added packaging, ZACROS will continue to promote the development of innovative technologies, products, and services in the future in order to contribute to the development of global health, medicine, and pharmaceuticals.

  • ZACROS' proprietary orbital-shaking bioreactor

20ℓ bioreactor

2000ℓ bioreactor

  • Single-useproducts for biologics manufacturing processes

*For inquiries about BioPhaS® and product information:

BioPhaS® Brand Site (Japanese only): https://biophas.zacros.co.jp/

■ Related Inquiries

General Affairs Department, Fujimori Kogyo Co., Ltd. URL: https://www.zacros.co.jp/english/inquiries/

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Fujimori Kogyo Co. Ltd. published this content on 30 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 July 2021 12:08:11 UTC.