What is a "golden batch" and how does AVEVA PI System help reproduce it?
The "golden batch" refers to the repeatable process that consistently optimizes the yield and quality of a biological batch. At Boehringer Ingelheim, AVEVA PI System aggregates and contextualizes production data to feed multivariate analysis techniques. This approach makes it possible to identify the operating parameters associated with the best batches and then reproduce them. For inherently variable biological batch processes, it is a powerful method for transforming pharmaceutical industrial performance.
Why is multivariate analysis essential for biological processes?
Biological processes involve dozens of interdependent variables (temperature, pH, dissolved oxygen, nutrient feed, etc.) whose combination determines yield. Classic univariate analysis is not enough. AVEVA PI System, combined with Sartorius Stedim Data Analytics tools, provides the contextualized data needed for multivariate analysis. This advanced statistical method identifies critical interactions between parameters, paving the way for prescriptive process control and a lasting reduction in production deviations.
What operational results has Boehringer Ingelheim achieved with AVEVA PI System?
Boehringer Ingelheim reduced production deviations, increased batch potency, cut batch destruction and improved overall yield. For a pharmaceutical manufacturer, every destroyed batch is a major financial loss due to the unit value of biologics and the associated investigation costs. AVEVA PI System thus delivers direct ROI by making biological processes more reliable, while strengthening compliance with GxP requirements thanks to complete, contextualized traceability.
How do you move from offline monitoring to prescriptive process control?
Offline monitoring analyzes batches after they finish, which prevents any correction. Prescriptive control, fed in real time by AVEVA PI System, recommends operating adjustments during the process to stay close to the golden batch. This transition requires reliable, contextualized data accessible in real time, which the AVEVA platform provides. For Boehringer Ingelheim, it is a major qualitative leap in mastering biological processes and industrial performance.
Why does a pharmaceutical manufacturer partner with a data analytics specialist?
Boehringer Ingelheim partnered with Sartorius Stedim Data Analytics to benefit from sharp industry expertise in biological multivariate analysis, complementing the AVEVA PI System platform. This combination of technology and domain expertise is a winning model in pharma: AVEVA provides the reliable, contextualized industrial database, and the specialist partner brings algorithms tailored to bioprocesses. This ecosystem approach accelerates ROI and ensures adoption by scientific teams.