WuXi Biologics Achieves 6 g/L/day Novel Productivity in Pilot-Scale Continuous Process
WuXi Biologics, a leading Contract Research, Development, and Manufacturing Organization (CRDMO), recently achieved a significant milestone in end-to-end Drug Substance (DS) manufacturing at pilot scale using its proprietary ultra-high productivity continuous bioprocessing platform, WuXiUPTM. The successful implementation occurred at the non-GMP pilot plant in Shanghai, China, with plans for further deployment across WuXi Biologics' global manufacturing sites.
A breakthrough was realized with WuXiUPTM, attaining an average daily productivity of 6 g/L/day for a monoclonal antibody (mAb) during an 18-day production phase. This resulted in a notable accumulated volumetric productivity of 105 g/L over the 25-day continuous cell culture process. Downstream processing achieved a nearly 80% total yield from Protein A capture to UF/DF, generating over 3 kg of protein from a 40 L working volume.
The continuous capture approach significantly reduced Protein A resin requirements per batch, promising cost savings in clinical manufacturing. Integrated downstream unit operations enhanced operational efficiency with minimal facility footprint utilization. To ensure real-time process monitoring and control, the continuous manufacturing process incorporated custom-fit Process Analytical Technology (PAT). This allowed monitoring of cell concentration, titer, purity, turbidity, monomer purity, and protein concentration.
The WuXiUPTM platform's impact on end-to-end continuous DS manufacturing is noteworthy, with a 1,000 L disposable bioreactor capable of producing over 60 kg of mAb per batch and approximately 800 kg per year. This productivity level rivals traditional 10,000-20,000L bioreactors. The platform not only ensures high productivity and superior product quality but also accelerates biologics development, reduces the cost of goods (COGS), and offers increased operational flexibility with minimal facility footprint requirements. The WuXiUPTM platform's breakthrough approach integrates continuous cell culture operations with continuous column chromatography, achieving higher purification yields compared to traditional step-wise unit operation purification processes.
