药明生物创新生物工艺技术平台WuXiUI™成功完成首次2000升GMP生产放大

上海

2024年8月30日

全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）今日宣布其创新型超强化分批补料生物工艺平台WuXiUI™成功完成首次2000升生物药原液GMP生产，表达量高达18g/L，达到常规分批补料工艺的四倍，能够实现产量的大幅提升。

此次生产中，该平台下游强化工艺将纯化处理能力提升一倍，降低下游处理时长50%，实现下游收率70%，产品质量和杂质去除可与常规分批补料工艺相媲美，还可节约30-50%的物料消耗，减少废物产生，最终大幅降低整体生产成本，提升生物药生产的经济效益。

药明生物于2023年推出WuXiUI™，能够提升不同CHO细胞系及其他哺乳动物细胞系所表达的多种产品类型的产量和质量，为全球客户提供具有成本效益的新型生物工艺解决方案，满足其不断增长的治疗性蛋白和抗体药物的研发和生产需求。与此同时，得益于其更少的培养基消耗和废弃物产生，以及更低的生产线建设面积需求，相较于传统或其他强化补料批次工艺，该技术平台碳足迹也更低。此次WuXiUI™成功完成2000升生产放大，充分证明该技术平台的稳定性，具备大规模生产的应用能力。

值得一提的是，此次生产放大还应用了药明生物自研平台细胞培养基MagniCHO™，它能为强化的生物培养工艺提供更丰富的营养物质，支持细胞更好地生长，并具备更大的目标蛋白合成潜力。与此同时，为了加强操作效率和生产控制稳定性，此次生产放大还应用了拉曼过程分析技术（PAT），在开展实时监控的同时，首次实现在GMP环境中进行实时自动化工艺控制。

陈智胜博士

首席执行官

药明生物

关于药明生物

Shanghai,

August 30, 2024

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 18g/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. 

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