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药明生物在成功实现WuXiUP™中试规模全连续生产的基础上，通过引入膜层析、自动化控制等前沿技术，并对PAT技术进行迭代优化，进一步实现中试规模的全自动化原液连续生产
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经升级的WuXiUP™全自动化连续生产平台将在提升生产效率和产品质量方面发挥更大作用，赋能客户加速生物药从研发到商业化的全流程
上海，
2025年8月12日
全球领先的合同研究、开发与生产（CRDMO）服务企业药明生物（WuXi Biologics, 2269.HK）宣布，其超高效连续灌流生产技术平台WuXiUP™成功完成中试规模的端到端全自动化原液连续生产，未来将进一步在主要GMP生产基地推广应用，以更高效、更灵活的技术能力，赋能客户加速生物药从研发到商业化的全进程。
WuXiUP™全自动连续生产线通过全线集成自动化系统，可实现24/7小时不间断高效运转，大幅减少人工操作环节，降低产品质量风险，提升生产效率。WuXiUP™上游总时长24天的连续细胞培养总产量突破110 g/L，单日产量最高可达7.6 g/L，在同类工艺中处于领先水平。下游工艺中，平台引入两步高效膜层析技术，相较传统树脂填料，其传质速度更快，实现产能5-10倍的跨越式提升。
为进一步保障下游连续纯化过程的质量监控，WuXiUP™还应用了经迭代的过程分析技术（PAT），实现对收获细胞培养液中蛋白纯度、蛋白浓度及pH、电导等关键参数的实时监控与反馈。结合自动化系统形成的闭环控制体系，可通过停留时间分布计算对质量波动样品进行智能分流，全面提升对于生产流程的稳定控制。
陈智胜
博士
药明生物首席执行官
WuXiUP™平台此前已在商业化生产中成功应用，充分验证了其技术成熟度与产业化价值，此次又成功实现中试规模全自动化原液连续生产，彰显了药明生物在创新技术领域的持续精进，更为生物药研发生产的数字化、自动化进程树立了标杆。技术创新与自动化，不断推动药物研发的效率革命，同时在保障药品质量方面发挥着愈发关键的作用。依托深厚的技术积淀与丰富的产业经验，药明生物将持续赋能全球客户高效推进药物研发，让创新疗法更快惠及全球患者。
关于WuXiUP™
WuXiUP™是药明生物自主研发的超高效连续灌流生产技术平台，为新一代生物药的研发与生产提供更高产量、更优质量、更具经济效益及工艺灵活性的解决方案。该平台适用于多种生物药蛋白的生产，包括单抗、双抗、融合蛋白及其他重组蛋白，相较于传统补料批次工艺与传统灌流工艺，生产效率可提升5-20倍。
WuXiUP™平台通过1000升及2000升一次性生物反应器，即可实现10000升至20000升传统不锈钢生物反应器的年生产能力。目前使用WuXiUP™技术生产的生物药蛋白中，已有一款获批上市，另有11个分子已通过IND审批。
关于药明生物
药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。
药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2024年12月底，药明生物帮助客户研发和生产的综合项目高达817个，其中包括21个商业化生产项目（不包括新冠项目）。
药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。更多信息，请访问：www.wuxibiologics.com
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WuXi Biologics' WuXiUP™ Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale
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Building on its success in developing continuous production at pilot-scale with the WuXiUP™ platform, WuXi Biologics has further enhanced the technology to achieve automated continuous drug substance (DS) manufacturing at pilot-scale. This advancement integrates industry-leading technologies, including membrane chromatography and automated control systems, along with iterative enhancements to Process Analytical Technology (PAT)
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The WuXiUP™ automated continuous production platform will deliver greater value as it boosts manufacturing efficiency and product quality, enabling clients to accelerate the journey of their innovative therapies from development to commercialization
Shanghai
August 12, 2025
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its intensified perfusion culture process platform, WuXiUP™, has achieved end-to-end, fully automated continuous drug substance（DS）production at pilot scale. The automated continuous production platform will be deployed across the company's major GMP facilities, offering clients greater efficiency and flexibility to accelerate the journey of their innovative therapies from development to commercialization.
By fully integrating an automated system, the continuous production platform enables non-stop 24/7 operation, which minimizes manual intervention, reduces quality risks, and enhances manufacturing efficiency. In upstream processes, WuXiUP™ has accomplished exceptional performance: 24 days of continuous cell culture yields a total output that exceeds 110 g/L, with a peak daily yield of 7.6 g/L. For downstream purification, WuXiUP™ incorporates a two-step, high-efficiency membrane chromatography system. Compared to traditional resin-based stationary phases, this technology enables faster mass transfer, delivering a 5- to 10-fold increase in productivity.
To strengthen quality control throughout downstream continuous purification, WuXiUP™ employs advanced, iteratively improved Process Analytical Technology (PAT), which provides real-time monitoring and feedback on critical parameters in Harvested Clarified Cell Culture Fluid (HCCF), including protein purity, concentration, pH, and conductivity. When integrated with the automated closed-loop control system, the technology utilizes Residence Time Distribution (RTD) analysis to intelligently divert out-of-spec samples, significantly enhancing manufacturing procedure control.
Dr. Chris Chen
Chief Executive Officer
WuXi Biologics
The WuXiUP™ platform has already proved its technical maturity and viability in commercial manufacturing. And now it has reached another significant milestone: accomplishing fully automated continuous DS production at pilot scale. Such achievements underscore WuXi Biologics' steadfast dedication to furthering technological innovation, and advancing the standards for digitalization and automation in biopharmaceutical R&D and manufacturing — both of which are critical capabilities to improve quality and accelerate timelines. With our deep technical expertise and extensive track record, WuXi Biologics remains committed to enabling our global clients to speed drug development more efficiently, benefiting patients worldwide.
About the WuXiUP™
WuXiUP™ is an intensified perfusion culture process developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. Compared to traditional fed-batch and perfusion processes, WuXiUP™ enables the manufacturing of diverse pharmaceutical proteins, including mAb, bispecific antibody, fusion protein, and other recombinant protein, with 5–20× higher productivity.
This performance advantage is particularly notable when scaling to 1,000–2,000 L using single-use bioreactors, where it achieves productivity levels comparable to those of traditional 10,000–20,000 L stainless steel bioreactors. The WuXiUP™ platform has enabled one molecule to receive BLA approval and 11 others to receive IND approvals.
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 December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).
WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
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