WuXi Biologics, a global company with leading open-access biologics technology platforms, announced that it has successfully completed the first GMP production at the new 24,000L line of its drug substance facility MFG5.
This follows the initial GMP operations of the 36,000L biomanufacturing line of MFG5 this February.
With its total 60,000L capacity, MFG5 will further support the growing demand for manufacture of late-phase and commercial projects across multiple modalities, such as monoclonal antibodies, bispecifics and fusion proteins. As a result, there is a total of approximately 150,000L biomanfacturing capacity at WuXi Biologics, which makes the company holding Top 5 capacity in the global CDMOs.
As one of the largest cGMP biologics manufacturing facilities in the world to employ only single-use bioreactors, MFG5 has comparable cost structure as any current largest biologics facilities running up to 25,000L scale
The new 24,000L line utilises the scale-out strategy combining twelve 2000L single-use bioreactors to enable the various production processes – including fed-batch, perfusion and CFB – at different scales, ranging from 2,000L to 12,000L. In addition, the implementation of WuXiUP continuous downstream technology in the 24,000L line for commercial production will allow MFG5 to increase productivity and reduce Cost of Goods Sold (COGS).
"As one of the largest cGMP biologics manufacturing facilities in the world to employ only single-use bioreactors, MFG5 has comparable cost structure as any current largest biologics facilities running up to 25,000L scale," said Chris Chen, CEO of WuXi Biologics. "The demand for commercial manufacturing from global companies has been growing fast due to the success of our 'follow and win-the-molecule' strategy."