Hitachi Chemical Advanced Therapeutics Solutions, LLC announces an agreement by which apceth Biopharma GmbH (“apceth Biopharma”), a contract manufacturer of cell and gene therapy products, will join Hitachi Chemical’s PCT 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 (ATMP regulation (EC) No.1394/2007) 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 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, PhD, CEO and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector.
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