WuXi PharmaTech, a research and development outsourcing company, has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors that are ready for cGMP manufacturing. Previously WuXi AppTec had built a cGMP biologics manufacturing facility with two cell culture suites containing a 500 L and a 1000 L disposable bioreactor. With the expansion, the company operates the largest biologics facility with disposable bioreactors in China and the largest disposable bioreactor in the world, according to a press announcement. WuXi AppTec can now support Phase III clinical manufacturing and initial commercial launch for therapeutic antibody and recombinant protein drugs.
The company also completed the first run of the 2000 L disposable bioreactor using an NS0 mouse myeloma cell line for TaiMed Biologics' ibalizumab, a CD4 entry inhibitor for the treatment of HIV/AIDS infection. WuXi AppTec reproduced in disposable bioreactors a manufacturing process originally implemented in traditional stainless steel bioreactors, with comparable process performance and product quality, the company reports.
Source: WuXi PharmaTech