WuXi Biologics Successfully Implemented a Fully Integrated Continuous Process with a Breakthrough Productivity of ~6 g/L/day at Pilot Scale

• By leveraging WuXiUP^TM, 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
• This end-to-end continuous bioprocess, which is in place for WuXi Biologics global manufacturing network, is currently being scaled up to GMP manufacturing  

SHANGHAI, Nov. 22, 2023 /PRNewswire/ -- 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 WuXiUP^TM, 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^TM: 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^TM, 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 WuXiUP^TM 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."

About WuXiUP^TM 

WuXiUP^TM, a proprietary ultra-high productivity continuous bioprocessing platform, is designed by WuXi Biologics to accelerate biologics development and manufacturing as well as to improve biologics accessibility and affordability.

With this new continuous processing platform, ultra-high productivity can be achieved in almost all biologics including mAbs and fusion proteins, with cell culture time periods similar to batch processes. Using a propriety continuous cell culture, a productivity of 51g/L has been achieved, which is more than 10 times the productivity of a 3-5g/L traditional fed-batch process. Suitable for commercial-scale production, the breakthrough WuXiUP^TM platform couples continuous cell culture operations with continuous column chromatography, achieving higher purification yields than traditional step-wise unit operation purification processes.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2023, WuXi Biologics is supporting 621 integrated client projects, including 22 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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