Takeda: Real-Time MVDA Monitoring of Biopharmaceutical Manufacturing Process With SIMCA®-online
Takeda’s presentation touched on how data analytics is applied across their ten sites globally, with over 40 SIMCA® models currently deployed. What makes MVDA modeling at Takeda unique is that it is used to analyze not only batch but also continuous systems. According to Baptiste Duhem, Digital Transformation Lead at Takeda, feeding MVDA models with continuous data can add a new dimension to their ability to detect deviations sooner.
With processes involving manual or semi-automated platforms (such as chromatography column packing), data can actually be added to the model by breaking these steps down into phases to standardize data collection.
Sanofi (Vaccines): Process Monitoring and Troubleshooting
Sanofi scientists explained the importance of data contextualization and infrastructure when it comes to making data “business ready.” At Sanofi, there are several data sources that feed into their data analytics tools, and that without the proper data infrastructures in place, it could lead to “wasted time/rework, delayed decision making due to manual work before analysis, and additional FTEs.”
At Sanofi, MODDE®, SIMCA®, and SIMCA®-online are used in combination to improve process observability. Data analytics starts in the early stages of planning and process design and is extended all the way to optimizing commercial manufacturing processes. Sanofi also touched on some of their current initiatives to improve process monitoring techniques by incorporating Raman-based MSG monitoring and fermenter feeding, process analytical technology (PAT) for in-line measurements of CQAs during TFF steps, and image analysis for drug substance vial inspection.
The Umetrics® Suite of data analytics software gives users access to powerful and easy-to-use tools to optimize manufacturing processes and bring quality products to market faster.
The annual Sartorius Data Analytics User meeting gives Umetrics® Suite users - and those interested in learning more about how data analytics can be applied to process development or process optimization - a chance to hear insights from practical applications.
The 2022 meeting demonstrated the broad capabilities of the Umetrics® Suite and how it can be applied to solve industry problems. The meeting also facilitated in-person networking between expoerts, customers, and partners to drive future collaborations.
To download the presentations, visit the User Meeting page.