Full Title: Development and Implementation of Intensified Bioprocessing for Biologics Manufacturing
There are increasing needs for flexibility and speed in bioprocessing, as well as lower Cost of Goods in biologics manufacturing. In order to accelerate biologics development and manufacturing as well as to improve affordability of biologics, WuXi Biologics developed a proprietary biologics production platform, WuXiUP, with Ultra-high Productivity. With WuXiUP the cell culture has achieved productivity of 2.5g/L/day and 51g/L bioreactor volume in a 20-day process for an Fc-fusion protein. The Platform enables almost any biologics, including mAbs and fusion proteins, to be manufactured at ultra-high productivity. The intensified and continuous cell culture process can be rapidly developed or converted from traditional fed-batch process with excellent scalability and robustness. This next generation biologic manufacturing solution enables 1,000-2,000L disposable bioreactors to achieve similar productivity as traditional 10,000-20,000L stainless bioreactors, which will expedite product launch and significantly reduce the Cost of Goods of a commercial product.