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
“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
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.
Hitachi Chemical Advanced Therapeutics Solutions, LLC
+1 201 515 2153
Source: Hitachi Chemical Advanced Therapeutics Solutions