Hitachi Chemical Co., Ltd. (HCC), a global service provider for the cell therapy industry through its PCT development and manufacturing service platform, today announced the completion of construction and opening of its Yokohama, Japan facility on October 11. This facility, as well as the existing two U.S. PCT facilities, will share the same global PCT service platform for quality and information systems, manufacturing operations, and technology transfer protocols, ensuring a seamless approach to serving clients and accelerating creation of a global commercial manufacturing enterprise.
This GMP-compliant 47,000-square-foot cell therapy manufacturing facility has been constructed with an initial three ISO 7 controlled environment rooms (CERs) with ISO 5 biological safety cabinets available. The facility is expandable up to fourteen CERs total. The facility houses cryostorage, quality control laboratories, manufacturing development capabilities, and is designed for compliance with Japan Pharmaceuticals and Medical Devices Agency (PMDA) requirements. The Yokohama facility is within close proximity to Yokohama, Haneda and Narita airports. Validation of the facility to begin client manufacturing is expected to complete by April 2018.
Robert A. Preti, Ph.D., Chief Executive Officer and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) and General Manager, HCC Regenerative Medicine Business Sector, commented:
“Over the past year and a half, through the collaboration between members of our global team – knowledge transfer from our existing US personnel and the determined and dedicated efforts of our Japan team – we have tied together two ends of the world with a cell therapy product delivery platform that will create a truly harmonized global operation upon which further advances in our value proposition can be built.”
HCATS has recently announced a planned U.S. expansion of its PCT service platform through the addition of GMP manufacturing infrastructure and cleanroom capacity in Allendale, NJ, including the addition of a 49,700 square foot facility as well as upgrades to the existing facility in the same city, allowing HCATS to seamlessly support and provide manufacturing services for clinical and commercial applications.