By leveraging WuXiUP, WuXi Biologics has completed its first end-to-end continuous drug substance (DS) manufacturing from perfused cell culture to final UF/DF pool at pilot scale
WuXi Biologics building in Shanghai, China. (Credit: WuXi Biologics)
WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced today that it has accomplished end-to-end DS manufacturing at pilot scale utilizing WuXiUPTM, 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 WuXiUPTM: 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 utilisation.
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 WuXiUPTM, 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.
Dr. Chris Chen, CEO of WuXi Biologics, commented, “We’re proud to achieve fully integrated DS manufacturing utilizing WuXiUPTM for the first time. Developing next-generation manufacturing technologies to improve affordability of biologics is always aligned with our mission of accelerating and transforming how biologics are developed and manufactured within the global setting. With this breakthrough, we have advanced our capabilities to enable global partners to bring more affordable high-quality biologics to market for the benefits of patients worldwide.”
Dr. Weichang Zhou, President of Global Biologics Development and Operations and CTO, commented, “The achievement of WuXiUPTM reflects WuXi Biologics’ consistent focus on enhancing technology platforms such as continuous bioprocessing to provide efficient and cost-effective solutions for global clients. With these leading technology platforms, our combined industry-leading expertise and capabilities allow us to facilitate more efficient biologics development and manufacturing to meet diverse clients’ needs.”
Source: Company Press Release