During our recent trip to Europe, our team met with several chemical and pharmaceutical clients to review and plan projects and conduct in-house seminars. The dominant theme of our trip was batch processes in manufacturing, and we maintained that focus as we delivered our advanced 3-day course Multivariate Analysis of Batch Processes in Basel, Switzerland.
We noted that in the chemical industry, a primary goal is to command a higher price by becoming a premium supplier, and this demands tighter quality control. In bio-pharma, some companies are strapped for capacity but would like to delay the huge capital costs of building new batch reactors. Both of these goals can be achieved with advanced tools for managing the quality and yield of each batch.
But batch processes have some unique features that require specialized tools for finding and addressing the root causes of recurring batch quality and yield issues, and for real-time predictive monitoring and control to lock in these improvements. Multivariate analysis is well suited to batch processes when it is properly implemented to account for their dynamic, transient and non-linear characteristics.
The 80/20 Rule for Batch Monitoring and Control
Batch processes are different enough in personality that one-size-fits-all, shrink-wrapped software often falls short. Our consistent success in the area of batch analysis begins with the 80/20 rule, where about 80% of the required capabilities are common across industries and processes, and about 20% are customized.
This combination truly creates an engineered, custom-fit solution, setting the stage for successful real-time predictive batch monitoring and control. We have implemented this strategy with results as high as a 50% reduction in quality variation and a 20% increase in production capacity on the same equipment.
Making the Shift from Batch Monitoring to Mid-Batch Control
Leading companies are embracing the move from batch monitoring (monitoring the predicted end-of-batch quality and yield) to mid-batch control (making mid-batch corrections to ensure that the end-of-batch quality will be on-spec). But in the highly-regulated environment of pharma & bio-pharma, the idea of making mid-batch adjustments based on data is something that has never been investigated… until now.
This topic generated a lot of excitement during our trip, particularly because we are sharing our learnings with the FDA, NIST, and Johnson & Johnson as we jointly investigate model-based control for fed-batch cell cultures.
The Importance of an Engineering-Centric Approach
The secret to our successful batch analysis, monitoring, and control applications is an engineering-centric approach to software. Our results to date resonated with the process engineers, managers, and directors we interacted with during our trip.
As engineers, we can help you determine whether your existing set of measurements captures the important variations in batch evolution. And our deep understanding of control theory and experience in implementation inform key design decisions such as the timing of control actions and the appropriate selection of manipulated input variables.
We recognize the strategic importance of improving product quality and yield in your business, and we look forward to helping you meet those challenges with the right combination of tools for batch manufacturing. Contact us today.