ALLENDALE, N.J.--(BUSINESS WIRE)--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.
“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, MD, CEO of 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.
This 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.
The closing of the transaction is planned for April 2019.
About Hitachi Chemical Advanced Therapeutics Solutions
Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. (Hitachi Chemical) representing Hitachi Chemical’s Regenerative Medicine Business Sector in the United States. HCATS leverages nearly two decades of experience exclusively focused on the cell therapy industry. It provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. For more information about these services, please visit www.pctcelltherapy.com.