WuXi AppTec hits big time in disposable manufacturing
pharmafile | November 4, 2013 | News story | Manufacturing and Production | China, WuXi, antibody, bioreactors
China’s WuXi AppTec has completed the first production test run in its pair of disposable 2,000-litre cell culture bioreactors recently installed at its facility in Shanghai.
This provides further evidence that single-use technology is now fully industrialised in the biopharma sector.
The two bioreactors produced batches of an antibody drug called ibalizumab, a CD4 entry inhibitor in development at Taiwanese biotech company TaiMed Biologics as a treatment for HIV infection. The run was made using an NS0 mouse myeloma cell line.
The announcement marks a milestone “in the global biologics manufacturing industry”, said the company, as well as in WuXi’s use of disposable equipment in bioprocessing.
Growing NS0 cells in disposable bioreactors entails significant technical challenges, and there are few reported cases of growing NS0 cells in large disposable bioreactors, noted the company.
Moreover, it confirms that disposable bioreactors can be effectively used at commercial scale and that engineering obstacles such as the massive weight of the bags, mixing issues and disposal have been overcome. The disposable option is now a realistic alternative to stainless steel reactors, it said.
The contract manufacturing organisation (CMO) says it is now ready to take on client contracts for GMP manufacturing using the new reactors.
“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,” said the company in a statement.
The Shanghai plant opened last year with 500L and 1,000L single-use bioreactors, and WuXi is hoping the latest investment will add to the upward momentum in its commercial manufacturing operations, which rose nearly 4% in the first six months of this year to around $71 million.
WuXi’s chief executive Ge Li said recently that biologics manufacturing is a ‘unique opportunity’ for the company because it can offer accelerated access to the Chinese market thanks to its integrated biologics drug discovery and development capabilities, state-of-the-art production facilities and relevant regulatory approvals.
“Although there is overcapacity in biologics manufacturing facilities globally, our biologics manufacturing facility is the only one in China that meets global cGMP standards,” he said.
“Through this expansion, we can quickly address increasing market demand for high-quality and cost-effective manufacturing of biologics.”
Phil Taylor
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