The facility is designed for cell therapy products that contain viral vectors such as chimeric antigen receptor T cell (CAR-T cell) therapies. CAR-T cells are T cells taken from a patient's body, engineered to target specific cancers, and then reintroduced into the body.
The site is expected to become operational by mid-2016 and it will provide single-source contract development and cGMP manufacturing capabilities to support growth in the cell therapy industry, which has come from the likes of deals by Kite Pharma and Cardio3 Biosciences. Specifically, the new facility will provide manufacturing capability and capacity to meet the rapidly expanding demand around clinical trials and commercialization.
WuXi spokesman Aaron Shi told us: "The new facility is designed for cell therapies that use viral vectors," while for the other Philly facility that is being completed this year, these products do not use viral vectors. "For companies that have products that do not require a viral vector, they do not want to have viruses in the facility especially for commercial product. Therefore, we needed to build a new facility for products that require a viral vector."
The site supplements the company’s existing 16,000-square-foot cGMP cell therapy manufacturing facility, as well as a 45,000-square-foot facility for the manufacturing of allogeneic and autologous cell-based therapeutics that is expected to be completed by mid-2015. The 45,000-square-foot site relies on single-use and disposable equipment, Alan More, VP of cell manufacturing, told us previously.
By 2016, WuXi's available manufacturing capacity in the US will be 206,000-square-feet, which would help meet the anticipated market needs of clinical and commercial production for cell-therapy companies. These facilities will complement the company's current fully integrated facility for biological safety and lot release testing in Philadelphia.
"Cell therapies like CAR T cells offer important new treatment options for cancer patients, and WuXi aims to be at the forefront of this area of providing our partners with cutting-edge cGMP manufacturing capabilities and capacities," said Ge Li, Chairman and CEO of WuXi.