WuXi Biologics has achieved cell culture productivity for an Fc-fusion protein of 51 g/L and is confident it can be scaled up to 4,000 L.
Single-use bioreactors are limited to 4,000 L in capacity (though many biomanufacturers put 2,000 L as their upper limit). Using these bioreactors with mammalian cell line tech is problematic for large-scale commercial use due to the generally low productivity of such expression systems, usually sub-10 g/L.
But Chinese contract development and manufacturing organization (CDMO) WuXi Biologics claims it has achieved “a breakthrough in cell culture productivity for an Fc-fusion protein,” achieving productivity using a continuous cell culture platform of 2.5 g/L per day, equating to 51g/L over a 20-day process.
“We achieve this at 1-10 L scale and are confident that it can be scaled to the 1,000 to 4,000 L scale,” WuXi Biologics CEO Chris Chen told BioProcess Insider. “The process can be run for as long as 120 days.”
He attributed this to both the cell line and WuXi’s proprietary WuXiUP (Ultra-high Productivity) continuous process platform. For not the firm is working with Chinese hamster ovary (CHO) expression system, Chen added.
If the productivity levels scale up as claimed, a 1,000 L single-use bioreactor will be able to produce more than 30 kg of monoclonal antibodies (MAbs), the firm claims, or 500 kg per year. When used with a 2,000 L or 4,000 L single-use bioreactor, the system will not only compete with the productivity of 15,000 to 20,000 L stainless steel tanks, but also “expedite product launch and significantly reduce the Cost of Goods of a commercial product,” the firm says.
In 2017, the CDMO opened what it said was the world’s largest fully single-use biomanufacturing plant in Wuxi City, China, with 28,000 L of disposable capacity. But over the next four years, the firm plans to open 10 more fully single-use plants globally, including a 60,000 L plant in Wuxi, and a facility in Mullagharlin, Ireland with 48,000 L of fed-batch and 6,000 L of perfusion capacity.