Wuxi to equip new cell therapy plant with single-use systems
The 45,000-square-foot clinical and commercial manufacturing facility is expected to become operational in Q2 of 2015.
The facility will supplement WuXi's existing 16,000-square-foot cGMP cell therapy manufacturing facility in Pennsylvania. This expansion will support growing customer demand with single-source contract development and cGMP manufacture capabilities for allogeneic and autologous cell-based therapeutics.
Alan Moore, VP for cell manufacturing at Wuxi, told Biopharma-Reporter.com, “The facility in Pennsylvania has been chartered to support cell therapy manufacturing.” The location “made sense for us because of the current facility there that provides quality control and lab testing support.”
The new facility will be built using advanced modular design, with flexible clean room technology, and microcarrier cell culture systems.
Moore noted that the “rationale behind the facility is we have clients with encouraging therapies that are moving to large scale manufacturing and Wuxi is historically unique in being ahead of clients and ensuring adequate capacity as existing clients grow.”
Located in the Philadelphia’s Navy Yard, the new facility will complement WuXi's existing facility and capabilities which include analytical chemistry, cell banking, cell characterization, molecular biology and lot release testing, thereby providing fully integrated services for cell therapies in Philadelphia.
“Our approach for cell therapy is to use single use equipment and to rely on disposable systems as much as humanly possible…[we have] no intention to have stainless steel tanks in the facility,” Moore added.
The construction of the new facility comes on the heels of the company predicting that the company will see an increase in biologics manufacturing during 2014.