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European Consortium Validates Continuous API Manufacturing Platform

The project aims to support faster scale-up, stronger process control and more flexible API manufacturing.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Editor’s Take: Active pharmaceutical ingredients (APIs) form the backbone of modern medicine, driving the efficacy and safety of countless therapeutic products. Learn about key trends reshaping the global market.

The PIPAC consortium, composed of De Dietrich, Alysophil, Bruker and Novalix, has successfully completed a pilot program validating a continuous manufacturing platform for pharmaceutical active ingredients (APIs).

The platform combines continuous-flow chemistry, AI monitored real-time analytical monitoring and control to enable pharmaceutical compounds to be produced, monitored and optimized continuously rather than through traditional batch manufacturing.

The consortium successfully validated the technology through the continuous-flow production of fentanyl, one of the pharmaceutical industry’s most potent and tightly regulated active pharmaceutical ingredients. The achievement demonstrates the platform’s ability to operate under challenging manufacturing conditions and provides a foundation for the future production of other pharmaceutical ingredients.

By integrating continuous flow synthesis, AI monitored advanced process analytics and automated process control into a single platform, the consortium has demonstrated a manufacturing approach capable of delivering greater flexibility, enhanced process robustness and faster pathways from development to production.

Unlike traditional batch production, continuous manufacturing allows product quality and process performance to be assessed throughout production, enabling earlier intervention, reduced scale-up risk and more efficient use of resources.

The approach also opens the possibility of smaller, modular production units that could support future decentralized manufacturing strategies and strengthen regional pharmaceutical production capabilities.

Novalix designed and implemented the continuous-flow synthesis route. Bruker contributed advanced analytical capabilities, enabling continuous real-time measurement and monitoring of the process. Meanwhile, Alysophil developed AlchemDrive, an autonomous AI driven process-control platform that continuously analyses production data and adjusts key manufacturing parameters in real time. Finally, De Dietrich developed the industrial hardware platform and automation architecture, integrating synthesis, analytics and process control into a scalable manufacturing environment designed for future industrial deployment.

Frédéric Guichard, Group Executive Director, De Dietrich, said, “For decades, pharmaceutical manufacturing has relied on production models that were designed for a different era. Today, the industry faces new challenges: supply-chain resilience, production sovereignty, faster industrialization and greater flexibility. PIPAc demonstrates that it is possible to rethink how pharmaceutical ingredients are manufactured. By combining continuous production, real-time analytics and intelligent process control, we have created a platform that has the potential to transform how critical medicines are produced in the future.”

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