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
- 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
- 通过利用其超强化的批注平台WuXiUI,药明生物已经完成了首次将2,000升药物物质(DS)GMP制造比例放大,与传统的批注过程相比,生产效率提高了4倍。
- 通过利用WuXiUI和专有的细胞培养介质MagniCHO,取得了竞争性的性能表现,大幅降低了整体DS制造成本。
- WuXiUI从小规模到2,000升GMP制造的持续性能证明了该技术作为一种成熟和稳健的平台的先进性,并能显著提高生物制品生产的成本效益。
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 - 药明生物(2269.HK),全球领先的合同研究、开发和制造组织(CRDMO),宣布通过利用其专有的超强化批注生物处理平台WuXiUI,成功完成了2,000升药物物质(DS)GMP制造。该平台实现了18g/L的抗体滴定值,与常规批注过程相比提高了4倍,证明了WuXiUI在提高生产效率方面的高效率。
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,该公司改进的下游技术平台提高了翻番的纯化处理能力和类似的杂质去除效果,将下游处理时间缩短了50%,最终的DS产量达到70%,产品质量相当。此外,WuXiUI下游平台还实现了材料和消耗品利用率的减少30-50%,从而减小了废物产生。总DS产量的提高显著降低了制造成本,大幅提高了生物制品生产的经济效益。
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平台于2023年推出,提高了表达不同选择目标产品模式的多个CHO或其他哺乳动物细胞系的生产效率,同时保持了理想的产品质量。它为全球客户满足对以更低成本生产的治疗性蛋白和抗体的日益增长需求提供了有效的解决方案。与此同时,由于其更高效的介质消耗、较低的废物产生和对生产线建筑空间需求的减少,它也可以降低碳足迹。从实验室小规模到2,000升GMP制造的成功比例放大证实了该技术的稳健性和大规模生产的准备就绪性。
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通过应用富含养分的MagniCHO细胞培养基平台,改良了WuXiUI的表现,以加强工艺过程。此外,通过将拉曼过程分析技术(PAT)工具集成到扩大规模的制造中,不仅能用于工艺监控,还可以第一次在GMP环境下提供实时自动化工艺控制,提高了运营效率和生产稳定性。
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."
药明生物首席执行官陈地龙医生评论道:“WuXiUI的成功应用和成就是我们对技术创新的不懈追求的结果,这加速了生物制品的开发并实现了全球客户的成本效益。通过这一里程碑,我们增强了能力,使客户能够推出更具亲民、高质量的生物制品,造福全球患者。”
About WuXi Biologics
关于药明生物
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.
药明生物(2269.HK)是一家领先的全球合同研究、开发及制造组织(CRDMO),提供端到端的解决方案,使合作伙伴能够从概念到商业化研制和制造生物制品,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).
药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12,000名熟练的员工,利用其技术和专业知识为客户提供高效、具有成本效益的生物制品发现、开发和制造解决方案。截至2024年6月30日,药明生物支持742个综合客户项目,其中16个在商业生产中(不包括COVID CMO项目和非COVID休眠CMO项目)。
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.
药明生物将环境、社会和治理(ESG)责任视为我们的理念和业务战略的重要组成部分,并致力于成为生物制品CRDMO领域的ESG领导者。我们的设施使用先进的生物制造技术和清洁能源。我们还成立了一个由首席执行官领导的ESG委员会,以引领全面的ESG策略和实施,增强我们对可持续发展的承诺。
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