WuXi Biologics’ first GMP campaign in the new MFG3 facility has been completed successfully. The newly completed, 18,000 sq.-ft. clinical manufacturing facility includes process development labs and six production lines: 2 x 2,000L fed-batch, 1 x 1,000L fed-batch and 1 x 200L fed-batch, 1 x 1,000L perfusion and 1 x 500L perfusion.
The design can handle production from 50L–
2,000L scale fed-batch production and 125L–
1,000L scale perfusion production. The facility offers traditional fed-batch operations and new continuous perfusion suites coupled with continuous purification. With this addition, WuXi Biologics’ mammalian cell culture capacity in China has a total bioreactor capacity of approximately 43,000L and can run 10 GMP campaigns of different products ranging from 50L–
12,000L scale at the same time.
“We are continuing to expand our capacity to enable global partners and expedite biologics development. With this newly added capacity, WuXi Biologics will be able to enable 60 IND projects and 3 BLA projects per year, which showcases our unparalleled capacities,” said Dr. Chris Chen, chief executive officer of WuXi Biologics. “With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed and manufactured globally.”