Munich, April 4, 2019 – We are pleased to announce that Hitachi Chemical Co. Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter “Hitachi Chemical”) has completed its acquisition of apceth Biopharma GmbH (Head Office: Munich, Germany; CEO: Dr. Christine Guenther; hereinafter “apceth Biopharma”), a contract manufacturer of cell and gene therapy products, adding its capabilities to the Hitachi Chemical’s Regenerative Medicine Business Sector’s offerings.
apceth Biopharma manufactures cell and gene therapy products for American and European clients through two manufacturing sites in Munich, Germany, both certified for GMP manufacture since 2010. These facilities are fully compliant with all current EU regulations (ATMP regulation (EC) No.1394/2007) and ICH guidelines. The company’s strength stems from its experience and comprehensive quality management systems allowing the manufacturing and development of a wide range of complex cell and gene therapy products, which will be integrated into the Hitachi Chemical Regenerative Medicine Business Sector.
By combining apceth’s gene and cell therapy manufacturing expertise and facilities in Europe to Hitachi Chemical’s capabilities and facilities in North America and Japan, we will enhance our global footprint, while preserving what customers value most: high-quality GMP manufacturing from a trusted partner that is a pioneer in the industry. Existing clients of apceth Biopharma will enjoy continuity of service and executive leadership.
In the near future, Hitachi Chemical’s Regenerative Medicine Business Sector aims to offer customers the possibility to manufacture their products throughout Europe, North America, and Japan. Our combined strength will make us a world leader in the field and will allow us to address all of our customers’ manufacturing and process development needs.
Our global contract development and manufacturing services platform currently includes two U.S. facilities, in Allendale, NJ and Mountain View, CA, and a recently opened facility in Yokohama, Japan. Construction is underway for a third U.S. facility in Allendale, NJ that will provide manufacturing capability for products after the opening in April 2019.
About apceth Biopharma GmbH
apceth Biopharma, a subsidiary of Hitachi Chemical Co., Ltd. is a pioneering company in regenerative medicines and a leading and certified Contract Development and Manufacturing Organization for cell and gene therapeutics with a broad international customer base. apceth owns state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) and is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The company has a comprehensive expertise in GMP manufacturing of autologous and allogeneic cell types that are either native or genetically modified. It has long-standing experience with various cell products, including mesenchymal stem cells (MSCs), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells, cord blood derived stem cells, and has the potential to expand to CAR-T and induced pluripotent stem cell (iPSC) technologies. apceth has successfully obtained manufacturing licenses for multiple cell therapy products for clinical as well as commercial use. apceth’s CDMO team provides fully customized solutions in the development and production of every customer product and process. Located centrally in the heart of Europe, apceth can perform efficient and fast supply for patients all over the continent.
For more information on apceth, please visit www.apceth.com
About Hitachi Chemical Co., Ltd.
Hitachi Chemical Co., Ltd. (TSE：4217), headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at http://www.hitachi-chem.co.jp/english/
*The conversion rate is 1 euro = 124 yen.
About the Hitachi Chemical Regenerative Medicine Business Sector
The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 180,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.
For more information on North America services, please visit www.pctcelltherapy.com.
For more information on Europe services, please visit www.apceth.com.
For more information on Japan services, please visit
For more information on North America and Japan services, contact:
Director, Marketing and Communications
Hitachi Chemical Advanced Therapeutics Solutions, LLC
Tel: +1 201 786 7941
For more information on Europe services, contact:
Dr. Almut Windhager
Manager Business Development and Communications
apceth Biopharma GmbH
Tel: + 49 89 665472259