Cell therapy products are unique — they require specialized facilities, expert personnel, and dedicated resources to efficiently support clients' development and manufacturing needs.
With more than 200,000 square feet of global development and manufacturing space, Hitachi Chemical will offer globally harmonized GMP-compliant cell therapy manufacturing infrastructure. With facilities on both the east and west coasts of the United States, as well as a newly constructed facility in Yokohama, Japan (opened in 2018) and newly acquired European capabilities, our clients enjoy ideal geographic coverage, access to North American, European and Japanese markets, and redundancy capabilities to mitigate risk.
Features of our controlled environment rooms (CERs or cleanrooms) include:
All of our GMP-compliant facilities offer cell and tissue cryogenic storage rooms with controlled access; live facility and equipment monitoring with automated alarm call-out; and UPS connection, ensuring the highest level of quality control and risk mitigation for product storage.
In addition to CERs and cryostorage rooms, our facilities house GMP-compliant material management facilities, QC and analytical laboratories, as well as product and process development laboratories.
Our U.S. facilities are FACT-accredited, hold all requisite licensures, are registered with the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps) facilities, and maintain GMP-compliant quality systems. Our Yokohama facility is designed for compliance with Japan PMDA requirements.
The PCT Allendale facility in New Jersey is a 30,000-square-foot, GMP-compliant facility currently being expanded with the addition of a neighboring facility to house our growing operations, including expanding our capability to produce EU-compliant cell therapy products and to produce commercial cell therapy products. With approximately 1,300 square feet of CERs to support our existing and future clients, the Allendale facility offers capacity for projects in all stages of development ranging from process/product development to clinical cell therapy manufacturing, and soon commercial cell therapy manufacturing.
PCT Allendale is within close proximity to LaGuardia,
For more information on these capacity expansions, please read the press release.
The PCT Mountain View facility in California is a GMP-compliant, 25,000-square-foot cell therapy manufacturing facility with approximately 12,500 square feet of manufacturing operations space and 12,000 square feet of office space - ample capacity for projects in all stages of development ranging from process/product development to commercial cell therapy manufacturing, including fill/finish operations.
PCT maintains a California Drug Manufacturing License for the conduct of clinical trial manufacture and distribution of cell-based products. The facility also houses corporate offices for our California-based team.
PCT Mountain View is within close proximity to airports in San Francisco, Oakland and San Jose.
Hitachi Chemical’s Regenerative Medicine Business Sector has completed construction of PCT Yokohama, a GMP-compliant 47,000-square-foot cell therapy manufacturing facility with an initial three ISO 7 CERs with ISO 5 biological safety cabinets available (expandable up to 14 CERs total). The facility shares the same global PCT service platform, housing cryostorage, quality control laboratories, and manufacturing development capabilities. Validation of the facility to begin client manufacturing was completed in 2018.
PCT Yokohama is within close proximity to Haneda and Narita airports.
For more information on PCT Yokohama, read the full press release: PCT Establishes Global Contract Development and Manufacturing Services Platform with Opening of Yokohama, Japan Facility.