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. Through this deal, Hitachi Chemical will acquire two state-of-the-art GMP/BSL2 production facilities in Allendale, New Jersey and Mountain View, California, and a recently opened facility in Yokohama, Japan including 600 sq m of clean room area. 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 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. The addition of Apceth in Europe to Hitachi Chemical will complement the PCT global services platform’s global footprint. The closing of the transaction is planned for April 2019.