药明生物发布行业领先数字孪生平台 PatroLab™ 重塑生物药研发及生产范式

中国上海,

2026年1月12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）今日宣布正式推出行业领先的数字孪生平台 PatroLab™，重塑生物工艺开发与生产范式。PatroLab™深度融合先进拉曼过程分析技术（PAT）及计算机预测建模，实现智能化实时数据分析、主动过程控制，并加速决策。这一创新数字化解决方案可有效提升工艺性能，降低工艺风险，缩短药物开发周期，确保生物药生产的一致性与高质量，树立生物药研发与生产的效率和可靠性全新行业标杆，赋能全球客户加速产品上市，实现稳健的商业化供应。

PatroLab™平台以药明生物先进的拉曼 PAT 系统为技术核心，实现从传统静态离线检测向实时、非侵入式监测的重大跨越，可对40余项关键工艺表现和产品质量属性进行持续实时在线监测，帮助客户获得更深入的工艺洞察并加速数据驱动决策。

与传统方法相比，PatroLab™单批次数据密度提升近1000倍，使客户能够更高效地应用“质量源于设计”理念，加速生物工艺开发与生产，确保产品质量与卓越运营。

除过程实时监控外，该拉曼 PAT 系统还能对细胞培养基、缓冲液等复杂原材料实现快速化学表征，在投料环节即可精准识别分子层面的细微差异，支持提前介入干预，从源头降低批次失败风险，保障全生产流程的产品一致性。

凭借强大的实时监测能力，PatroLab™平台结合数据驱动与机理建模方法，应用数字孪生理念构建生物工艺的数字化镜像，支持从“被动响应”向“预测性决策”的转变。平台可进行基于计算模型的情景分析，用于评估工艺表现并辅助优化控制策略。

此外，通过提前识别潜在工艺风险、支持技术转移和放大过程中的根因分析，并辅助识别营养代谢或细胞状态相关的潜在工艺问题，PatroLab™可支持工艺性能的持续改进，确保产品质量稳定。这一创新是行业迈向更智能、更稳健的生物工艺策略的关键一步。

PatroLab™平台能够对关键质量属性（CQAs）提供全流程监测与管控，有助于降低工艺偏差与批次报废率，提升批次间质量稳定性与生产成功率。根据FDA与EMA的相关指南与倡导，平台支持实时放行检测（RTRT）功能，为生产过程产品质量控制策略提供重要补充，助力优化生产批次周转和放行周期。

此外，借助动态预测控制、多维数据分析及根因识别，PatroLab™可有效降低放大风险，减少因操作偏差或控制不一致导致的批次波动。自动化控制策略取代人工干预，显著提升生产效率、可靠性与一致性，帮助客户实现更快、更智能、更稳健的生产。

PatroLab™平台与药明生物端到端数字化生态协同，支持客户便捷访问知识管理系统，打破数据孤岛，促进生物药研发生产全流程的跨团队、跨企业实时分享协同。平台的实时可视化系统与动态趋势分析，支持及时的趋势偏移（OOT）预警与根因定位辅助，为生物制药生产控制的稳健性提供行业领先的解决方案。

WuXi Biologics Launches Industry-Leading Digital Twin Platform PatroLab™ Designed to Transform Bioprocessing and Manufacturing

Shanghai, China,

January 12, 2026

WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of PatroLab™, a state-of-the-art digital twin platform designed to transform bioprocess development and manufacturing. By combining advanced real-time process monitoring with Raman-based Process Analytical Technology (PAT) and predictive in-silico modeling, PatroLab™ enables real-time and smarter analytics, proactive control, and accelerated decision-making. This integrated digital solution helps enhance process performance, minimize process risks, shorten development timelines, and ensure consistent, high-quality biologics manufacturing. With PatroLab™, WuXi Biologics sets a new benchmark for efficiency and reliability, enabling global clients to achieve faster time-to-market and robust commercial supply.

Dr. Chris Chen

Chief Executive Officer

WuXi Biologics

Central to the PatroLab™ platform is WuXi Biologics’ advanced Raman PAT system, which marks a groundbreaking transition from conventional static, off-line testing to real-time, non-invasive monitoring of more than 40 key process performance and product quality attributes. This innovation enables deeper process insights and faster data-driven decisions.  

By increasing data density per batch by nearly 1,000 times compared to traditional methods, PatroLab™ empowers clients to apply QbD (Quality by Design) principles more effectively, and accelerate bioprocess development and manufacturing – all while ensuring product quality and operational excellence.

Beyond real-time process oversight, the Raman PAT system provides rapid chemical characterization of complex raw materials, such as cell culture media and buffers. It can detect subtle molecular-level variations at the point of use, enabling proactive interventions to reduce the risk of batch variations, and to safeguard end-to-end product consistency across each manufacturing run.

Building on its real-time monitoring capability, the PatroLab™ platform combines data-driven and mechanistic modeling approaches with digital twin concepts to create virtual bioprocess replicas. This enables a transition from reactive responses to predictive decision-making. Additionally, the platform supports “what-if” scenario analysis to assess process performance and refine control strategies. 

By identifying potential process risks early, supporting root cause analysis during technology transfer and scale-up, and detecting potential process deficiency related to nutrient metabolic bottlenecks or cell state shifts, PatroLab™ enables continuous improvement in process performance and enhances product quality consistency. This innovation marks a pivotal step toward smarter, more robust bioprocessing strategies.

The PatroLab™ platform reduces process deviations and batch rejection rates through end-to-end monitoring and control aligned with critical quality attributes (CQAs), ensuring batch-to-batch consistency and improving the overall success rate. In line with regulatory guidance and advocacy by the FDA and EMA, the platform enables the application of real-time release testing (RTRT), complementing in-process quality control strategies and contributing to optimized manufacturing turnaround and release cycle. 

By enabling dynamic, model-predictive control, and multidimensional data analysis and root cause identification, the platform minimizes scale-up risks and batch variability caused by operational deviations or process control inconsistency. Automated control strategies replace manual interventions, which drives higher efficiency, reliability, and consistency in biomanufacturing, and ultimately helps clients achieve faster, smarter, and more robust production.

The PatroLab™ platform is embedded into WuXi Biologics’ end-to-end digital ecosystem, offering easy access to a comprehensive knowledge management infrastructure that breaks down data silos and ensures real-time cross-team sharing and alignment for bioprocess development and manufacturing workflows. Its real-time visualization module combines dynamic trend analysis with timely out-of-trend (OOT) alert and efficient root cause identification, providing an industry-leading solution for more robust manufacturing control in the biopharma sector.