- PatroLabTM uses Raman-based Process Analytical Technology for real-time monitoring.
- The platform increases data density per batch by nearly 1,000 times.
- It supports 'what-if' scenario analysis for process performance assessment.
- PatroLabTM aligns with FDA and EMA guidance for real-time release testing.
Introduction
WuXi Biologics has launched PatroLabTM, a digital twin platform aimed at transforming bioprocess development and manufacturing. The platform integrates real-time process monitoring, Raman-based Process Analytical Technology (PAT), and predictive in-silico modeling.
Technological Advancements
PatroLabTM offers real-time, non-invasive monitoring of over 40 key process performance and product quality attributes. It increases data density per batch by nearly 1,000 times compared to traditional methods, enabling deeper process insights and faster data-driven decisions.
Process Improvement
The platform supports Quality by Design (QbD) principles, accelerating bioprocess development and manufacturing while ensuring product quality. It also provides rapid chemical characterization of complex raw materials, allowing proactive interventions to reduce batch variations.
Predictive Capabilities
PatroLabTM combines data-driven and mechanistic modeling with digital twin concepts to create virtual bioprocess replicas. This enables predictive decision-making and supports “what-if” scenario analysis to refine control strategies and enhance product quality consistency.
Regulatory Alignment
The platform aligns with FDA and EMA guidance for real-time release testing, reducing process deviations and batch rejection rates. It ensures batch-to-batch consistency and improves manufacturing success rates through dynamic, model-predictive control and automated strategies.
Collaboration and Integration
Embedded in WuXi Biologics’ digital ecosystem, PatroLabTM offers a comprehensive knowledge management infrastructure. It facilitates real-time cross-team sharing and alignment, enhancing bioprocess development and manufacturing workflows.
