On December 5, 2024 Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) and Japan Tissue Engineering Co., Ltd. (HQ: Gamagori, Aichi Prefecture; President & CEO: Ken-ichiro Hata; hereinafter "J-TEC") reported that they signed a basic agreement ("the Agreement") on December 3, 2024, with the aim of advancing (i.e., mechanizing and automating) manufacturing capabilities for regenerative medical products by utilizing innovative technologies, in order to accelerate the industrialization of regenerative medicine and cell therapy and to enhance sustainability (Press release, Sysmex, DEC 5, 2024, View Source [SID1234648830]). Going forward, both companies will start concrete strategic collaboration based on this Agreement.
One of the major challenges in the industrialization of regenerative medicine and cell therapy is the difficulty of manufacturing products from living cells. In particular, autologous cell products1 derived from patients’ own cells need to be manufactured to accommodate the non-uniform character of the cells from each patient. As a result, it is extremely challenging to mechanize and automate the manufacturing processes in a standardized manner. This creates a bottleneck in expanding the scale of production and enhancing efficiency in the regenerative medicine and cell therapy industry, and the transfer of manual manufacturing techniques therefore becomes an issue that directly affects the sustainability of the business.
Sysmex has contributed to the evaluation of cell functions by providing quality control testing2 capable of non-destructively analyzing cell characteristics, as well as Internet of Things (IoT) and other robotic technologies, to academic institutions and pharmaceutical companies that develop regenerative medical products. The company has also been working on automating manufacturing processes for the pipeline of our group companies and strategic partners.
J-TEC was the first company in Japan to develop and obtain approval of regenerative medical products, making it a pioneer in regenerative medicine. In particular, it has been working to commercialize and utilize autologous cell products in society. Based on the experience and knowledge gained in this process, the company has established a platform to stably supply products while maintaining high quality.
Both companies have been discussing ways to leverage their individual strengths to solve issues in the regenerative medicine and cell therapy industry, based on the technology and know-how they have developed through their respective business activities. As part of this, a basic agreement was signed on December 3, 2024, with the aim of enhancing manufacturing capabilities for regenerative medicine and cell therapy through innovative technologies.
Through open innovation based on the strengths of both companies, they will contribute to the sustainable development of Japan’s regenerative medicine and cell therapy industry by realizing the mechanization and automation of manufacturing processes for regenerative medical products, which is a key issue in the regenerative medicine and cell therapy industry.
Terminology
1
Autologous cell products:
Regenerative medical products manufactured from patients’ own living cells.
2
Quality testing that allows non-destructive cell analysis:
Testing that enables the analysis of cell quality without destroying the cells themselves. Since the cells do not need to be destroyed, it allows for the efficient and accurate testing of cell products in a short period of time.
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