勃林格英格翰-成功故事：引入多元数据流，以更主动的方式做出应对

Boehringer Ingelheim and the Quest for the Golden Batch

Challenge: Boehringer Ingelheim, a leading international pharmaceutical company, faces the challenge of maintaining consistent batch potency and reducing production variance in biological batch processes. Variation can arise at multiple points in the process, making it difficult to identify the key factors contributing to this variability.

Solution: To address these challenges, Boehringer Ingelheim partnered with Sartorius Stedim Data Analytics. They employed multivariate data analysis techniques (MVDA), including principal-component analysis (PCA) and partial least squares (PLS), to analyze historical data and create "golden-batch trajectories." These trajectories are used for real-time monitoring and prescriptive process control to optimize batch potency.

Implementation:

• Data Management: Managing the vast amount of data generated during the fermentation process was a significant challenge. Boehringer Ingelheim utilized AVEVA PI System to aggregate and contextualize diverse data streams, including SCADA, LIMS, process control, and attribute data.
• Event Tracking: The company implemented a parent-child event-frame model to closely monitor the various stages of the fermentation process, particularly the growth phase. This model helps in tracking specific process steps and stages.

Results:

• Reduced Production Variance: By identifying and targeting key process components, Boehringer Ingelheim has been able to reduce production variance.
• Increased Batch Potency: The use of MVDA techniques has helped in generating more potent batches.
• Reduced Batch Destruction: The improved process control has minimized the destruction of batches.
• Increased Yield: Overall yield has increased due to better process management.

Key Takeaways:

• Scalability and Reproducibility: The use of templates in AVEVA PI System ensures consistency and scalability, making it easier to implement advanced analytics across different platforms.
• Data-Driven Mindset: Boehringer Ingelheim has adopted a data-driven approach, allowing them to proactively manage and optimize their fermentation processes.

By leveraging AVEVA PI System and MVDA techniques, Boehringer Ingelheim has significantly enhanced its ability to manage and optimize its biological batch processes, moving towards achieving the "golden batch" goal.