WuXi Biologics announced that it has accomplished end-to-end DS manufacturing at pilot scale utilizing WuXiUP, a proprietary ultra-high productivity continuous bioprocessing platform at its non-GMP pilot plant in Shanghai, China. Currently, this well configured bioprocess is being scaled up to GMP manufacturing and will be deployed across WuXi Biologics' global manufacturing sites in China, Ireland, U.S., Singapore.WuXi Biologics achieved a major breakthrough utilizing WuXiUP: An average daily productivity of 6 g/L/day for a mAb molecule was obtained during the 18-day production phase, leading to a significantly high accumulated volumetric productivity at 105 g/L in the 25-day continuous cell culture process. During the downstream process, the total yield calculated from Protein A capture to UF/DF reached nearly 80%, delivering over 3 kg protein from 40 L working volume.

The continuous capture significantly reduced Protein A resin requirement per batch, which will significant lower the resin cost at clinical manufacturing stage. Meanwhile, the integrated downstream unit operations resulted in operational efficiency requiring minimal facility footprint utilization. To ensure real-time process monitoring, facilitate process control and product release, this continuous manufacturing process also utilized custom-fit process analytical technology (PAT) to monitor cell concentration, titer, purity, turbidity, monomer purity, and protein concentration.

With the end-to-end continuous DS manufacturing enabled by WuXiUP, a 1,000 L disposable bioreactor can produce more than 60 kg of mAb per batch and approximately 800 kg per year, achieving productivity comparable to a traditional 10,000-20,000L bioreactor. This industry-leading bioprocessing platform achieves high productivity and premier product quality which will expedite biologics development and reduce the cost of goods (COGS) of commercial products while increasing operational flexibility due to the minimal requirements for facility footprint utilization.