In This Article:
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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
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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
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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.