WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI in 2,000L GMP Manufacturing
WuXi Biologics Successfully Completes First Scale-Up of High-Productivity Bioprocessing Platform WuXiUI in 2,000L GMP Manufacturing
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.- 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
- 通過利用其超強化的批註平台WuXiUI，藥明生物已經完成了首次將2,000升藥物物質（DS）GMP製造比例放大，與傳統的批註過程相比，生產效率提高了4倍。
- 通過利用WuXiUI和專有的細胞培養介質MagniCHO，取得了競爭性的性能表現，大幅降低了整體DS製造成本。
- WuXiUI從小規模到2,000升GMP製造的持續性能證明了該技術作爲一種成熟和穩健的平台的先進性，並能顯著提高生物製品生產的成本效益。
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.
2024年8月30日，上海 - 藥明生物(2269.HK)，全球領先的合同研究、開發和製造組織(CRDMO)，宣佈通過利用其專有的超強化批註生物處理平台WuXiUI，成功完成了2,000升藥物物質(DS)GMP製造。該平台實現了18g/L的抗體滴定值，與常規批註過程相比提高了4倍，證明了WuXiUI在提高生產效率方面的高效率。
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.
此外，該公司改進的下游技術平台提高了翻番的純化處理能力和類似的雜質去除效果，將下游處理時間縮短了50%，最終的DS產量達到70%，產品質量相當。此外，WuXiUI下游平台還實現了材料和消耗品利用率的減少30-50%，從而減小了廢物產生。總DS產量的提高顯著降低了製造成本，大幅提高了生物製品生產的經濟效益。
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平台於2023年推出，提高了表達不同選擇目標產品模式的多個CHO或其他哺乳動物細胞系的生產效率，同時保持了理想的產品質量。它爲全球客戶滿足對以更低成本生產的治療性蛋白和抗體的日益增長需求提供了有效的解決方案。與此同時，由於其更高效的介質消耗、較低的廢物產生和對生產線建築空間需求的減少，它也可以降低碳足跡。從實驗室小規模到2,000升GMP製造的成功比例放大證實了該技術的穩健性和大規模生產的準備就緒性。
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.
WuXi Biologics通過應用富含養分的MagniCHO細胞培養基平台，改良了WuXiUI的表現，以加強工藝過程。此外，通過將拉曼過程分析技術（PAT）工具集成到擴大規模的製造中，不僅能用於工藝監控，還可以第一次在GMP環境下提供實時自動化工藝控制，提高了運營效率和生產穩定性。
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."
藥明生物首席執行官陳地龍醫生評論道：「WuXiUI的成功應用和成就是我們對技術創新的不懈追求的結果，這加速了生物製品的開發並實現了全球客戶的成本效益。通過這一里程碑，我們增強了能力，使客戶能夠推出更具親民、高質量的生物製品，造福全球患者。」
About WuXi Biologics
關於藥明生物
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.
藥明生物（2269.HK）是一家領先的全球合同研究、開發及製造組織（CRDMO），提供端到端的解決方案，使合作伙伴能夠從概念到商業化研製和製造生物製品，造福世界各地的患者。
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).
藥明生物在中國、美國、愛爾蘭、德國和新加坡擁有超過12,000名熟練的員工，利用其技術和專業知識爲客戶提供高效、具有成本效益的生物製品發現、開發和製造解決方案。截至2024年6月30日，藥明生物支持742個綜合客戶項目，其中16個在商業生產中（不包括COVID CMO項目和非COVID休眠CMO項目）。
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.
藥明生物將環境、社會和治理（ESG）責任視爲我們的理念和業務戰略的重要組成部分，並致力於成爲生物製品CRDMO領域的ESG領導者。我們的設施使用先進的生物製造技術和清潔能源。我們還成立了一個由首席執行官領導的ESG委員會，以引領全面的ESG策略和實施，增強我們對可持續發展的承諾。
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