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Hitachi Chemical Acquires apceth Biopharma

Hitachi nabs two state-of-the-art GMP/BSL2 production facilities including 600 square meters of cleanroom area

Hitachi Chemical Co. Ltd. has acquired apceth Biopharma GmbH.


apceth Biopharma manufactures cell and gene therapy products for American and European clients through two manufacturing sites in Munich, Germany, 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. Through this deal, Hitachi Chemical will acquire two state-of-the-art GMP/BSL2 production facilities including 600 m2 of cleanroom area.

“The addition of apceth Biopharma to Hitachi Chemical will strengthen our presence in the second-largest cell and gene therapy market in the world, and enable us to offer a truly harmonized global operation, providing our customers with ready access to new markets and maximizing the value we bring to the industry,” said Robert A. Preti, chief executive officer and president, Hitachi Chemical Advanced Therapeutics Solutions and general manager of the Hitachi Chemical Regenerative Medicine Business Sector.

“We are very pleased to become part of Hitachi Chemical. Our combined strengths within Hitachi Chemical will allow us to manufacture complex cell and gene therapies for clients in North America, Asia, and Europe. This will allow us to supply patients around the world with highly needed innovative and high-quality cell and gene therapies,” said Christine Guenther, chief executive officer, apceth Biopharma.

“Since 2007, Apceth had been built by a great team and strong support of its shareholders into Europe’s leading independent cell therapy manufacturer. We are very proud that these joint efforts resulted in apceth Biopharma now being chosen as Hitachi Chemical’s hub for cell therapy in Europe,” commented Manfred Ruediger, PhD, chairman of the Board of apceth GmbH & Co.KG.

Hitachi’s 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 commercial manufacturing capability for products after the opening in the second quarter of 2019. The addition of apceth in Europe to Hitachi Chemical will complement the PCT global services platform’s global footprint to jointly more than 180,000 square feet. All of these facilities will share harmonized quality and information management systems, accounting for all regional regulatory requirements, as well as harmonized manufacturing operations, and technology transfer approaches, designed to ensure a seamless and rapid approach to serving clients globally.
 
 

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