Hitachi Chemical : Yokohama Site Has Obtained a Manufacturing License for Regenerative Medicine Products

Jun 12, 2020
Hitachi Chemical Co., Ltd.

Hitachi Chemical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter 'Hitachi Chemical') announces that its Yokohama Site (Yokohama City, Kanagawa Prefecture) which commenced operation in April 2018 as a contract development and manufacturing facility for regenerative medicine products has obtained a license for manufacturing regenerative medicine products under the administrative jurisdiction of the Kanto-Shinetsu Regional Bureau of Health and Welfare, stipulated in the Pharmaceutical Affairs Law(1) as of June 2, 2020.

Regenerative medicine refers to treatment methods for transplanting cells derived from in-vitro cultures into the body in order to restore tissues, organs or immune functions damaged by injury or disease. These methods include cancer immunotherapy(2) and cell therapies using somatic stem cells(3) and iPS cells(4). With a notable increase in clinical applications in recent years, especially in cancer immunotherapy and somatic stem cell therapy, early establishment of a regenerative medicine market has been anticipated.

Hitachi Chemical acquired PCT, LLC, a Caladrius Company (currently Hitachi Chemical Advanced Therapeutics Solutions, LLC), a leading cell manufacturing contractor in the United States, in March 2017. To take advantage of its technology and operation knowhow relating to the development and manufacturing of regenerative medicine products, Hitachi Chemical established the Yokohama Site as a facility focused on cell development and contract manufacturing services and launched full operation in April 2018. A year later in April 2019, Hitachi Chemical acquired apceth Biopharma GmbH, a Germany-based firm undertaking contract manufacturing of regenerative medicine products mainly for pharmaceutical companies in Europe and the United States. Through these efforts, the Hitachi Chemical Group has been expanding its business of contract manufacturing of regenerative medicine products globally, thus far operating five sites: three sites in the United States (one in Mountain View, California; two in Allendale, New Jersey), one site in Japan (Yokohama City, Kanagawa Prefecture) and one European site (Munich, Germany).

Now that Hitachi Chemical has obtained a manufacturing license for regenerative medicine products under Japan's Pharmaceutical Affairs Law, the company will strive further to develop regenerative medicine through the manufacturing of investigational new drugs for regenerative medicine products and pharmaceutical drugs based on the law. Hitachi Chemical also aims to establish a manufacturing technique for the mass production of regenerative medicine products in the future in order to contribute to improving patients' quality of life.

(1) The law governing the manufacturing, sales, distribution, advertisement, etc. of drugs, quasi-drugs, cosmetics, medical devices and regenerative medicine products in Japan.
(2) Cancer immunotherapy is a cancer treatment method 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.
(3) Somatic stem cell is the general term for stem cells found in various tissues of the body.
(4) iPS cell is a type of artificial stem cell produced by transducing genes into cells collected from a donor's skin, etc. and culturing. iPS cells have the ability to proliferate and
differentiate into various cells.