Hitachi Chemical : Establishing a New Contract Development and Manufacturing Facility for Regenerative Medicine Cell Therapy

October 11, 2016
Hitachi Chemical Co., Ltd.

Hitachi Chemical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama) announces its investment of approximately two billion yen in establishing a new contract development and manufacturing facility for regenerative medicine cells and other products in Yokohama City, Kanagawa Prefecture, to enter the promising regenerative medicine market. The advanced facility will begin full operation in April 2018.

Regenerative medicine refers to treatment methods for transplanting cells derived from in-vitro cultures into the body in order to restore organs or immune functions damaged by injury or disease. These methods include cancer immunotherapy and cell therapies using somatic stem cells and iPS cells. In recent years, clinical applications especially in cancer immunotherapy and somatic stem cell therapy have notably increased. The regenerative medicine market is expected to develop rapidly with deregulation in Japan and the commercialization of iPS cells, while the global market in related industries is projected to expand around 2025, reaching 5 trillion yen in 2030 and 15 trillion yen in 2050.
The regenerative medicine market in Japan is also expected to surge with the introduction of the Act on the Safety of Regenerative Medicine in November 2014. This legislation allows for conditional early market approval of the manufacture and sale of regenerative medicine products for limited terms if their efficacy is predictive and their safety confirmed.

To capitalize on the potential demand in the domestic market, Hitachi Chemical has embarked on the establishment of its own contract development and manufacturing facility.
This facility will allow Hitachi Chemical to take advantage of its expertise accumulated through clinical drug trials, pharmaceutical authorization, and manufacturing and sales under Japan's Pharmaceutical and Medical Device Act, while utilizing its highly structured quality management systems as well as the Hitachi Group's facilities, equipment, process control software and development technology for automated cell manufacturing systems. In addition, Hitachi Chemical will receive support from PCT, LLC, A Caladrius Company (Head office: New Jersey, USA; President: Robert Preti; hereinafter 'PCT') with its expertise in production methods, manufacturing and inspection of regenerative medicine cells, and knowhow in the contract manufacturing business. Through these efforts, Hitachi Chemical will realize the development and manufacture of high quality cells and other products in compliance with the 'Ordinance on Good Gene, Cellular and Tissue-based Product Manufacturing Practices,' the standard enacted by the Ministry of Health, Labour and Welfare for fiscal 2018.
The new facility will be located about a 20-minute drive from Haneda Airport (Tokyo International Airport), allowing manufactured cells to be transported to major regions throughout Japan within 24 hours. The facility will also have the production capacity for manufacturing investigational new drugs and mass-producing pharmaceutical drugs to meet the various needs of customers, including pharmaceutical companies and venture firms developing regenerative medicine products. Furthermore, in partnership with PCT, Hitachi Chemical seeks to compete in the global market in the future.

Name	Medical Business Unit Yokohama Office, New Business Development Headquarters (tentative)
Address	Yokohama City, Kanagawa Prefecture
Number of employees	Approximately 60 (planned, as of April 2018)
Principal line of business	Contract development and manufacture of regenerative medicine cells and products
Investment amount	Approximately 2 billion yen
Total floor space	About 4,000 m
Start of full operation	April 2018 (scheduled)

*1Cancer immunotherapy is a method of treatment for cancer that involves activating and strengthening immune cells outside the body, before returning the cells to the body for the enhanced immune system to inhibit cancer cell proliferation. *2Somatic stem cell is the general term for body cells in different tissues.*3'iPS' cell is a type of master cell that has the ability to proliferate like stem cells and differentiate into various cells. This cell technology has a high potential for applications in regenerative medicine. *4Source: Ministry of Economy, Trade and Industry (2013), Final Report Compiled by the Study Group on Commercialization and Industrialization of Regenerative Medicine*5The Pharmaceutical and Medical Device Act is a law enacted on the management requirements for drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine products in Japan.*6Regenerative medicine product is a product that is processed under the responsibility of a company using processed cells for regenerative medicine.*7Investigational new drug is a drug under investigation for its effectiveness prior to gaining manufacturing approval from the Ministry of Health, Labour and Welfare.*8Pharmaceutical drug is a drug used to diagnose, treat or prevent diseases. Its development, production and use are regulated by laws that ensure the quality, efficacy and safety of drugs and medical devices.