- By leveraging its ultra-intensified fed-batch platform, WuXiUI, WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing, achieving a 4-fold productivity improvement compared to the traditional fed-batch process
- The competitive performance achieved through the utilization of both WuXiUI and the proprietary platform cell culture media MagniCHO led to significant reduction in overall DS manufacturing COGS
- The consistent performance of WuXiUI - from small scales to 2,000L GMP manufacturing - is a testament to the advancement of the technology as a mature and robust platform capable of significantly improving the cost-effectiveness of biologics production
SHANGHAI, Aug. 30, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully accomplished 2,000L drug substance (DS) GMP manufacturing by utilizing its proprietary ultra-intensified fed-batch bioprocessing platform WuXiUI. The platform achieved a titer of 18 g/L, a 4-fold increase compared to conventional fed-batch process, demonstrating the high efficiency of WuXiUI in improving productivity.
In addition, the company's enhanced downstream technology platform enabled doubled purification processing capacity and similar impurity removal, which resulted in a 50% reduction in downstream processing time and a final DS yield of 70% with comparable product qualities. Moreover, WuXiUI downstream platform also enabled 30-50% reduction in the utilization of materials and consumables and therefore downsized waste generation. The improvement in total DS production contributed to significant reduction in manufacturing COGS, a substantial economic efficiency improvement in biologics production.
The WuXiUI platform, launched in 2023, enhances the productivity of multiple different CHO or other mammalian cell lines that express diverse product modalities, while maintaining desirable product qualities. It provides an effective solution for global clients to meet the growing demand for therapeutic proteins and antibodies with lower COGS. At the same time, it allows for a lower carbon footprint due to its more efficient media consumption, lower waste generation, and reduced demand for building space in the production line. The successful scale-up of the WuXiUI platform from bench scales to 2,000L GMP manufacturing confirms the robustness of the technology and its readiness for larger-scale production.
WuXiUI's strong performance was boosted through the application of MagniCHO, WuXi Biologics' proprietary platform cell culture media enriched with nutrients for intensified processes. Furthermore, operation efficiency and production robustness were improved by integrating the Raman Process Analytical Technology (PAT) tool into the scale-up manufacturing, not only for process monitoring, but also - for the first time under GMP settings - to provide real-time automated process control.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful application and achievement of WuXiUI is a result of our relentless pursuit of technology innovation to speed up biologics development while achieving cost efficiency for global clients. With this milestone, we have enhanced our capabilities to enable clients to bring more affordable, high-quality biologics to market, benefiting patients worldwide."
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, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding COVID CMO projects and non-COVID dormant CMO project).
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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