For more than 30 years already, we have known MES in life sciences – electronic data is where we feel at home. Based on this data, combined with data from other sources, our new EMI apps offer Data Analytics & AI tools to create tangible benefits for pharma and biotech processes. By applying a use case approach, we tackle problems and generate quick wins for our customers. We aim at optimizing the overall value chain in a factory in an easy way!
Hans-Peter Subel, CTO, Werum IT Solutions
Our Manufacturing IQ apps
Data from a variety of sources will be accessed and evaluated using state-of-the-art algorithms and visualizations. Intelligent data analysis for your manufacturing facility allows a wide range of applications – from automated report generation to predictive analytics and even real-time process interaction.
Our apps create comprehensive visibility, pinpoint critical process phases and identify correlations and causalities. They help you understand manufacturing constraints and suggest measures to correct them. You gain a comprehensive overview of the operations in your factory enabling you to take action immediately!
Automated decision for API extraction from chromatography columns
Enabling objective comparisons and decision-making. Single- to multi-site view of your manufacturing operations
Automated generation of quality reports, e.g. CPV/OPV, APQR/PQR
More apps to come…
Better process performance by using AI and predictive analytics
Data gathering and report creation with a few clicks instead of lengthy manual processes
Validated system compliant with life science regulations
Business case “Chromatography Control”: API yield increase in high value biotech
A leading multinational pharma and life sciences company from Germany has commissioned Werum to integrate a prediction model for the optimal time to extract an API into a biopharmaceutical manufacturing process.
The API is separated from undesired secondary components by means of an extraction process using chromatography columns in the downstream phase. Until now, this had been done by an experienced employee who decided on the start and end times of the extraction based on IPC data.
From the history of this chromatography data, Werum generates a prediction model based on neural networks. The model predicts the optimal time to extract the API and will be simultaneously integrated into the process.
The benefits for the pharma company are invaluable: Through the process optimization, they can increase their product yield by about one percent of additional API.
API yield increases of highly optimized extraction process of up to 3% are possible
Business case “Quality Reporting”: Reduced generation times and higher quality confidence
Werum supports the pharma and biotech industry to automatically generate quality reports such as Continued Process Verification (CPV), Ongoing Process Verification (OPV), Annual Product Quality Review (APQR) and Product Quality Review (PQR).
With Werum’s Quality Reporting, report creation is highly automated with less routine work. QA personnel simply select product and time frame in the app. The report including all statistics is generated by the system. QA personnel evaluate process abnormalities which are automatically detected and add their assessments to finalize the report.
Today, this process is mostly manual and involves a large share of repetitive work. In addition, errors are not easily detected. Usually, it takes at least a week for a report to be finalized – multiple times a year for each product!
Benefit from a substantial reduction of repetitive work and shorter report generation times: Now, it can take less than a day per product to create the quality report! The process is harmonized, of high quality and less error-prone – providing a tool for report generation across manufacturing locations.