Hitachi Chemical Company plans to move into Europe with its acquisition of Apceth Biopharma, thereby expanding Hitachi’s global footprint of its Cell and Gene Therapy Contract Development and Manufacturing Services.
New Jersey/USA – Hitachi Chemical Advanced Therapeutics Solutions has recently announced an agreement by which Apceth Biopharma, will join PCT Hitachi Chemical’s global services platform.
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 and ICH guidelines. The company’s strength lies in its experience and comprehensive quality management systems allowing the manufacturing and development of a wide range of complex cell and gene therapy products. Through this deal, Hitachi Chemical will acquire two state-of-the-art GMP/BSL2 production facilities including 600 sq m of clean room area.
This global contract development and manufacturing services platform currently includes two U.S. facilities, in Allendale, New Jersey and Mountain View, California, and a recently opened facility in Yokohama, Japan. Construction is underway for a third U.S. facility in Allendale, New Jersey 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. All of these facilities will share harmonised quality and information management systems, accounting for all regional regulatory requirements, as well as harmonised manufacturing operations, and technology transfer approaches, designed to ensure a seamless and rapid approach to serving clients globally.
The closing of the transaction is planned for April 2019.