March 19, 2018 - Hitachi Chemical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter “Hitachi Chemical”) announces the signing of an agreement with Daiichi Sankyo Co., Ltd. (Head Office: Chuo-ku, Tokyo; hereinafter “Daiichi Sankyo”) for clinical manufacturing*1 of Regenerative Medicine developed by Daiichi Sankyo for the Japanese market. Hitachi Chemical plans to start manufacturing the clinical product at the new facility in Yokohama City, Kanagawa Prefecture.
Regenerative medicine refers to treatment methods that involve transplanting cells derived from in-vitro cultures into the body to help restore organs or immune functions damaged by injury or disease. These methods include cancer immunotherapy and cell therapies using somatic stem cells, engineered immune cell therapy and iPS cells. In recent years, clinical applications have notably increased, especially in cancer immunotherapy and somatic stem cell therapy. The regenerative medicine market is expected to develop rapidly with deregulation in Japan and the commercialization of iPS cells.
Along with other various factors, the establishment of a highly appraised manufacturing facility in Japan, capable of manufacturing not only clinical products but also commercial products for regenerative medicine by utilizing the manufacturing control systems and manufacturing machines of the Hitachi Group, including Hitachi Ltd., was a key factor leading to this agreement. As for the commercial manufacturing*2 for regenerative medicine, bilateral negotiations will continue between the two parties.
In May 2017, Hitachi Chemical wholly acquired Hitachi Chemical Advanced Therapeutics Solutions, LLC, a major company in the field of contracted manufacturing of regenerative medicine products in the United States, and will begin operation of its process development/contracting manufacturing facility with PCT platform in April 2018 as the company’s third global base and largest scale facility in Japan. Hitachi Chemical plans to operate the contracted manufacturing business for regenerative medicine in Japan and around the world, including Europe and the United States.
About the PCT Platform
PCT is the global cell therapy manufacturing and development service platform of the Hitachi Chemical Regenerative Medicine Business Sector, leveraging nearly two decades of PCT platform experience exclusively focused on the cell therapy industry. The PCT Service Platform includes contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. Hitachi Chemical’s development and manufacturing facility in Yokohama City, Kanagawa Prefecture, providing the PCT Platform, will begin full operation in April 2018 as the largest scale facility of its kind in Japan. U.S. facilities providing this service platform are already in operation in New Jersey and California. Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. (Hitachi Chemical) representing Hitachi Chemical’s Regenerative Medicine Business Sector in the United States. More information about the PCT Services Platform is available at http://www.pctcelltherapy.com
- *1 Manufacturing of products for clinical trial use to verify their clinical efficacy before obtaining MHLW (Ministry of Health, Labour and Welfare) approval.
- *2 Manufacturing of commercial products after obtaining MHLW (Ministry of Health, Labour and Welfare) approval.
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