Cell and gene therapy manufacturing facility
Hitachi Chemical Advanced Therapeutics Solutions (HCATS) opened its new manufacturing facility in New Jersey, US, in January 2020, developed to meet the demand for cell and gene therapy manufacturing services.
It will manufacture the company’s cell and gene therapy products as well as support clients in commercialising cell and gene therapies. The facility will allow HCATS to expand its manufacturing capacity in New Jersey by more than two times.
The company is expected to hire up to 500 employees to support operations.
The new cell and gene therapy manufacturing facility is at 75 Commerce Drive, Allendale, New Jersey, covering an area of approximately 55,000ft2.
The company operates another manufacturing facility in Allendale, New Jersey, which serves as the headquarters.
Allendale facility is near significant airports including Newark, John F Kennedy International Airport, and LaGuardia.
The facility comprises more than 3,800ft² of classified support areas and 1,200ft² of controlled environment rooms (CERs).
It has six environment rooms, as well as the provision for additional rooms on customer demand.
Infrastructure at the site also includes manufacturing development labs, laboratories dedicated to microbiology and quality control, meeting rooms, executive offices and warehouse.
The facility meets Current Good Manufacturing Practice (cGMP) regulations and covers systems, such as materials, instruments and facility controls, corrective and preventative action (CAPA), validation, internal and external audits and training.
The existing cGMP-compliant manufacturing facility in Allendale covers a total area of 30,000ft², offering manufacturing capabilities to support customers from the product development stage through to clinical manufacturing of cell therapy.
The Allendale facility includes six clean rooms and approximately 1,300ft² of CERs, allowing the company to enhance its cell therapy products manufacturing capability.
As part of the PCT service platform, HCATS also carried out improvements to the existing facility to enable better the process flow.
Hitachi Chemical Advanced Therapeutics Solutions operates as a subsidiary of Hitachi Chemical and handles the company’s Regenerative Medicine Business Sector (RMBS) in the North America region. The company offers contract development and manufacturing services in the US through the PCT global platform.
The company has been in the cell therapy industry for more than 20 years. It provides services such as commercial manufacturing, clinical manufacturing and manufacturing development.
The company also has a 25,000ft² facility in Mountain View, California, which focuses on manufacturing process development and clinical manufacturing.
In addition to the US facilities, HCATS operates facilities in Munich, Germany, and Yokohama, Japan. The RMBS has a footprint covering more than 200,000ft².
The company offers industry experience in a range of aspects including cell engineering technologies, cell culture and expansion, automation and biological analytical methods.
The expertise will allow customers to advance the commercialisation of products in multiple cell therapies, including T-cells (CAR, TCR, Treg), dendritic cells, natural killer cells, mesenchymal cells, hematopoietic stem cells, as well as autologous and allogeneic applications.
In 2017, Hitachi Chemical acquired the remaining interest in PCT in a $75m transaction, following which, PCT was renamed as Hitachi Chemical Advanced Therapeutics Solutions (HCATS).
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