We are delighted to announce today that WuXi Biologics division had completed a cell culture capacity expansion, including two 2000L disposable bioreactors that are ready for cGMP manufacturing. Previously WuXi 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 AppTec 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 is now poised to support Phase III clinical manufacturing and initial commercial launch for therapeutic antibody and recombinant protein drugs.
We are also delighted to anounce the 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 reproduced in disposable bioreactors a manufacturing process originally implemented in traditional stainless steel bioreactors, with comparable process performance and product quality. Read Full Press Release .