PCT GMP Manufacturing Infrastructure And Cleanroom Capacity Expands To Support Clients Through Commercial Stage
Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), a global service provider for the cell therapy industry, announced the planned expansion of its PCT development and manufacturing service platform through the addition of GMP manufacturing infrastructure and cleanroom capacity in Allendale, NJ.
The expansion includes the addition of 49,700 square feet in a new facility in Allendale (its 75 Commerce facility) as well as upgrades to the existing facility at 4 Pearl Court, allowing HCATS to support and provide manufacturing services for clinical and commercial applications.
The 75 Commerce 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, 1,200 square feet of controlled environment rooms, 3,800 square feet of classified support areas, and additional support areas will be constructed with facility validation complete by the end of 2018.
The existing 4 Pearl Court 30,000 square foot 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, with facility validation by the end of June 2018.
Robert Preti, Ph.D., Chief Executive Officer and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC and General Manager, Regenerative Medicine Business Sector, Hitachi Chemical, commented: “Cell therapies continue to offer tremendous hope for patients and significant progress is being made in bringing these therapies into clinical practice. 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 U.S.-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 complete 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, according to the company.