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Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.
Hitachi Chemical Advanced Therapeutics Solutions (HCATS), a global service provider for the cell therapy industry through its PCT development and manufacturing platform, announced the planned expansion of its PCT service platform through the addition of GMP manufacturing infrastructure and cleanroom capacity in Allendale, NJ, in an Oct. 10, 2017 press release. HCATS is the new name of CDMO PCT. PCT became an independent business unit focused on cell therapy and regenerative medicine within the life sciences division of Hitachi Chemical earlier in 2017, and as of Sept. 29, 2017, PCT changed its name to HCATS and established PCT as the name of its global service platform.
The expansion includes the addition of 49,700 ft2 in a new facility in Allendale as well as upgrades to a nearby existing facility, allowing HCATS to support and provide manufacturing services for clinical and commercial applications. The new facility will house additional Grade B/ISO 7 controlled environment rooms, HCATS’ Center for Innovation and Engineering, manufacturing development labs, quality control and microbiology labs, warehousing, and executive offices. By the end of October 2018, 1200 ft2 of controlled environment rooms, 3800 ft2 of classified support areas, and additional support areas will be constructed, with facility validation complete by the end of 2018. The existing 30,000-ft2 manufacturing facility, housing six clean rooms, will be renovated for improved process flow and commercial infrastructure, with completion of these upgrades expected by the end of April 2018 and facility validation by the end of June 2018.
“Cell therapies continue to offer tremendous hope for patients, and significant progress is being made in bringing these therapies into clinical practice,” said Robert Preti, CEO and president of Hitachi Chemical Advanced Therapeutics Solutions and General Manager, Regenerative Medicine Business Sector, Hitachi Chemical, in the press release. “Success of this industry will rely, however, on providing sufficient manufacturing capacity while simultaneously advancing the state of cell therapy manufacturing. Expansion of our infrastructure and achieving commercial readiness is essential as we continue to advance and accelerate our clients’ cell therapy products from development to clinical and commercial cGMP manufacturing.”
In parallel with the facility expansion, HCATS anticipates that the increase in demand for cell therapy development and manufacturing services will result in substantial growth of the company’s employee base in the coming year.
In addition to expansion of US-based capacity and commercial readiness, work is continuing on a new contract development and manufacturing facility for regenerative medicine cells and other products in Yokohama, Japan. Initial construction will be completed at this location in October 2017, with facility validation complete by April 2018. All locations will share the same global PCT service platform for quality and information systems, manufacturing operations, and technology transfer protocols.