Biomanufacturing: Predicting vial-filling stability in real time and saving approximately $700,000 per year in rejected product.
A vial-filling stability model Fraunhofer USA CMA (CMA) built for a major US generic-drug manufacturer now saves the company approximately $700,000 a year in rejected product, while maintaining full regulatory compliance.
The manufacturer was losing hundreds of thousands of dollars annually to rejected vial batches caused by filling-process instability. The root causes were subtle, and the existing quality-control process caught problems too late.
CMA developed an AI model that predicts vial-filling stability in real time, reading the process sensor data the line already produces and flagging deviations before they become batch failures.
The savings land with the manufacturer. The consistency lands downstream, with the hospitals and patients who depend on a steady drug supply.
Fraunhofer USA Center Mid-Atlantic CMA