World’s largest single-use plant begins cGMP production
WuXi Biologics began building a $150m (127m) single-use site in WuXi City, China back in 2015 and today announced it has initiated cGMP production at the plant.
The site consists of two 1,000L single-use bioreactors for perfusion processes alongside 14 2,000L fed-batch cell culture disposable vessels, supplied by Thermo Fisher, though a spokesperson from WuXi told us other vendors have also equipped the site.
The company has “the ambition to be one of the global leaders in commercial manufacturing,” and the commencement of operations at the world’s largest single-use facility supports this, the spokesperson said.
We were also told the 30,000L capacity was “mostly filled” through current customer demand, and WuXi has a target 80% utilisation rate at the site.
The first product to be made at the site is one for its customer Tesaro, though the specific molecule and quantity was not disclosed by the spokesperson.
The Waltham, Massachusetts-based oncology-focused biopharmaceutical company has a strategic partnership with WuXi, and Tesaro’s candidate TSR-022, a monoclonal antibody targeting TIM-3 is made using the CDMO’s biologics platform.