Yokohama, Japan, October 19, 2017: 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.
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About Hitachi Chemical Co., Ltd.
Hitachi Chemical has been manufacturing medical products focusing on diagnostic reagents since 1981. Utilizing the expertise accumulated through clinical drug trials, pharmaceutical authorization, and manufacturing and sales under Japan`s Pharmaceutical and Medical Device Act, Hitachi Chemical aims for an early launch of a contract manufacturing business by establishing high quality, low cost automated cell culture systems for cancer immunotherapy and other cell-based therapies, while also promoting consumable materials such as containers and reagents.
About Hitachi Chemical Advanced Therapeutics Solutions, LLC
Hitachi Chemical Advanced Therapeutics Solutions, LLC, (HCATS) is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. representing its Regenerative Medicine Business Sector. Its vision is a world in which transformative cell-based therapeutics are accessible to all, and its mission is to provide its clients with high-quality, scalable, innovative, reliable and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies. HCATS offers PCT (www.pctcelltherapy.com), a cell therapy manufacturing and development service platform, leveraging nearly two decades of experience exclusively focused on the cell therapy industry. The PCT service platform includes contract development and manufacturing organization (CDMO) services, at current Good Manufacturing Practices (cGMP) standards, including clinical and commercial manufacturing, and manufacturing development. In the future, the company will expand the scope of its services to offer other services or products distinct from those currently under PCT, under separate platforms.
For more information, visit www.hitachi-chem-ats.com
