WuXi Biologics Successfully Completes Its First 2000L Disposable Bioreactor Run Using an NS0 Cell Line, Marking an Industry Milestone
SHANGHAI and TAIPEI, October 30, 2013 — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced that it had completed a cell culture capacity expansion including two 2000L disposable bioreactors that are ready for cGMP manufacturing. Previously WuXi Biologics had built a state-of-the-art cGMP biologics manufacturing facility with two cell culture suites containing a 500L and a 1000L disposable bioreactor, respectively. As a result of this new expansion, WuXi Biologics operates the largest biologics facility with disposable bioreactors in China and the largest disposable bioreactor in the world. The facility has passed GMP audits from global clients and an audit by former U.S. FDA biologics inspectors. WuXi Biologics is now poised to support Phase III clinical manufacturing and initial commercial launch for therapeutic antibody and recombinant protein drugs.
WuXi Biologics also announced completion of the first run of the 2000L disposable bioreactor using an NS0 mouse myeloma cell line for TaiMed Biologics’ ibalizumab, a novel CD4 entry inhibitor for the treatment of HIV/AIDS infection. This event marks an important milestone in the global biologics manufacturing industry. Growing NS0 cells in disposable bioreactors entails significant technical challenges, and there are few reported cases of growing NS0 cells in large disposable bioreactors. Through intensive process research and development, WuXi Biologics reproduced in disposable bioreactors a manufacturing process originally implemented in traditional stainless steel bioreactors, with comparable process performance and product quality.
“Successful completion of our biologics facility expansion and the subsequent 2000L run mark important milestones in WuXi Biologics’s mission of building first-class biologics manufacturing capabilities in China,” said Dr. Ge Li, Chairman and Chief Executive Officer of WuXi Biologics. “Although there is overcapacity in biologics manufacturing facilities globally, our biologics manufacturing facility is the only one in China that meets global cGMP standards. Through this expansion, we can quickly address increasing market demand for high-quality and cost-effective manufacturing of biologics. The first 2000L run also showcases our solid development and scale-up capabilities in mammalian cell culture. We continue to invest to build our integrated open-access biologics discovery, development, and manufacturing platform to serve our global clients and to play a pivotal role as the gateway for introducing biologics into the Chinese market.”
“WuXi Biologics has made excellent progress in producing clinical-trial supplies for ibalizumab, an important new medicine for global patients,” said Dr. James Chang, Chief Executive Officer of TaiMed Biologics. “We are delighted to have such a skilled and reputable manufacturing partner as we enter into late-phase trials of ibalizumab in the United States and Asia.”