WuXi to Add cGMP Cell Therapy Capacity in U.S.
WuXi PharmaTech announced that it has broken ground on a new cell therapies manufacturing facility in Philadelphia. The biotechnology and medical device R&D services company with operations in China says the new facility is expected to become operational in the second quarter of 2015.
To be located in the Philadelphia 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. The new facility, says WuXi, will supplement the company’s existing 16,000-square-foot cGMP cell therapy manufacturing facility — the extra capacity consisting of 45,000 square feet of clinical and commercial manufacturing space supporting fully integrated services for cell therapies in the U.S.
The expansion, says WuXi, is in response to growing customer demand for single-source contract development and cGMP manufacture capabilities for allogeneic and autologous cell-based therapeutics. "Cell therapies offer important treatment options, and WuXi is committed to bringing them to patients faster," said Dr. Ge Li, Chairman and CEO of PharmaTech.
The new facility will be built using advanced modular design, with flexible clean room technology, disposable equipment and microcarrier cell culture systems. According to Biopharma-reporter.com’s coverage of the new plant announcement, the company plans to conduct manufacturing process by relying primarily on single-use systems.
In related news, WuXi TaiMed Biologics says the FDA has approved the first batch of ibalizumab (TMB-355) a drug substance and sterile drug product manufactured at WuXi's biologics facilities. According to WuXi, this is the first reported FDA approval of a sterile biologics product manufactured in China for use under a U.S. IND, which marks an important milestone of WuXi's investment to expedite global development of innovative biologics. Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral-entry inhibitors. It is being developed by TaiMed Biologics for the treatment of HIV/AIDS infection.
WuXi's cell culture manufacturing facility, which recently received an honorable mention facility-of-the-year award by ISPE, was manufactured at the newly completed state-of-the-art cGMP parenteral manufacturing facility located within the same campus as the cell culture facility at Wuxi city. The automated filling line can accommodate 2-50mL liquid and lyophilized vial products for global clinical trials and product launch.