Cell Resources Co., Ltd. Launches Supply of Human Umbilical Cord and Amnion-Derived Mesenchymal Stromal Cells for Research Use

Cell Resources Co., Ltd. (headquartered in Chiyoda-ku, Tokyo; President and CEO: Kotaro Arata; hereinafter "Cell Resources"), a subsidiary engaged in regenerative medicine-related businesses, announces the launch of supply of human umbilical cord and amnion-derived mesenchymal stromal cells (MSCs) (hereinafter "the product") as a new cell source for research and development related to regenerative medicine products, including the development of reagents and automated culture systems, effective today.

Details are as follows:

1. Background and Purpose

MSCs are a population of cells present in various tissues such as bone marrow, adipose tissue, umbilical cord, and dental pulp, possessing multipotency※1 and being applied to various diseases. Among them, MSCs derived from fetal appendages such as human umbilical cord and amnion are attracting attention as promising cell sources due to their high proliferative capacity※2 and non-invasive collection methods. While clinical trials using MSCs are advancing in the field of regenerative medicine, the stable supply of human cell materials remains a challenge for the development of regenerative medicine products and related industries in Japan.

The Alfresa Group, responsible for the stable supply of pharmaceuticals and other products as social infrastructure, is promoting the establishment of a "Regenerative Medicine Total Supply Chain Service (TSCS※3)" covering everything from raw material supply to delivery to medical institutions. Cell Resources aims to contribute to the industrialization of cell therapy through social implementation of regenerative medicine products by establishing a comprehensive CDMO※4 service system, including the provision of domestic cell raw materials (master cells), manufacturing of cell processing products, and partnerships with domestic and international alliance partners.

Now, Cell Resources has established the capability to ship the product—a domestically sourced MSC from Japanese medical institutions—as a new cell source for research and development related to regenerative medicine, including the development of regenerative medicine products, reagents, and automated culture systems, from its cell culture and processing facility, the "Koriyama Cell Processing Center." Supply will commence accordingly.※5

※1 Multipotency: The property of having the ability to differentiate into various types of cells.

※2 Proliferative capacity: The property of being able to increase cell numbers through repeated cell division.

※3 TSCS: Refers to the seamless integration and utilization of various functions across the Alfresa Group to establish a smooth supply chain, providing integrated services from the introduction and development of pharmaceuticals and other products, through manufacturing, logistics, sales, post-marketing surveillance, and last-mile delivery.

※4 CDMO (Contract Development and Manufacturing Organization): An organization that undertakes the development of pharmaceutical manufacturing processes, as well as the production of investigational and commercial drugs.

※5 The product is limited to research use only. To promote appropriate use, a suitability review based on the intended use and the execution of a Material Transfer Agreement (MTA) are required when providing the cells.

2. Product Overview

(Note) The product is made available through partnership sales channels with Kanto Chemical Co., Inc., which has a nationwide trading network with universities, research institutions, and life science-related companies, and Alfresa Shinohara Chemical Co., Ltd., a subsidiary of our company operating sales and logistics networks in the Shikoku region, enabling customers to purchase through existing trading routes.

※6 Safety Data Sheet (SDS): A document detailing hazardous information necessary for the safe handling of the product, as well as storage and disposal methods.

※7 Test Report: A document detailing quality test results such as cell count, viability, and sterility testing.

※8 Technical Sheet: A document detailing technical information regarding the storage, thawing, culture, and subculture of the product.

3. Product Features

(1) Domestic Production

The product is manufactured at the "Koriyama Cell Processing Center," Cell Resources' cell culture and processing facility, which holds a license for manufacturing specified cell processing products (License No.: FA2230001), using fetal appendages donated with consent from donors at medical institutions in Japan.

(2) Proliferative Capacity

The cells can stably increase in number through repeated replication.

(3) Fetal Sex Disclosure

At the time of product supply, the fetal sex information from the fetal appendages used as manufacturing materials is disclosed, enabling cell selection according to research objectives. Information related to the fetus is managed in a way that does not allow personal identification, and personal information is not disclosed to Cell Resources.

4. Future Outlook

The impact of this initiative on the current fiscal period's performance is expected to be minor at present, but it is considered beneficial for enhancing the corporate value of our group in the medium to long term.

Should any matters requiring disclosure arise in the future regarding this initiative, we will promptly announce them.

【Inquiries】

· For those considering purchasing the product:

Cell Resources Inquiry Page (https://cellresources.co.jp/contact/)

· For media inquiries:

Alfresa Holdings Corporation Corporate Communications Department Tel: 03-5219-5102 Email: [email protected]

【Reference】

· Product Web Page

https://cellresources.co.jp/our-business/#mastercell

· About Kanto Chemical Co., Inc.

Kanto Chemical Co., Inc. is a comprehensive reagent manufacturer providing products across a wide range of fields, including analytical reagents, pharmaceutical raw materials, in vitro diagnostic drugs, and electronic industrial chemicals, supporting customers' research and development. Leveraging its long-standing technical expertise and product development capabilities, the company actively contributes to the life sciences field, focusing on regenerative medicine, cell culture, and genetic engineering. It offers a wide variety of products used in regenerative medicine and drug discovery research, including cell culture media, cell culture scaffolds, and media supplements, meeting diverse needs from basic research to clinical applications. In addition to its own products, the company contributes to the advancement of the regenerative medicine field by distributing high-quality regenerative medicine-related products from domestic and international sources nationwide.

https://www.kanto.co.jp/

· About Alfresa Shinohara Chemical Co., Ltd.

Alfresa Shinohara Chemical Co., Ltd., a subsidiary of our company, headquartered in Kochi City, Kochi Prefecture, operates its business base across the four prefectures of Shikoku, providing sales of clinical diagnostic drugs, pharmaceuticals, medical and hygiene materials, and related services to hospitals, clinics, testing centers, universities, and research institutions. In the medical sector, it handles clinical diagnostic reagents, hygiene materials, and clinical diagnostic equipment; in the physicochemical sector, it handles analytical research reagents and physicochemical analysis instruments, providing comprehensive support from sales to maintenance and servicing. Additionally, in the nursing care business, it operates nursing care facilities and day services, and provides services such as the sale and rental of welfare and nursing care products and home modifications. Leveraging its logistics and service network covering the entire Shikoku region, the company contributes to the development of regional medical care and nursing services.

https://www.alf-shinohara.com/index.html