A European consortium has validated a continuous manufacturing platform designed to improve flexibility and resilience in pharmaceutical ingredient production.

The PIPAC consortium, made up of De Dietrich, Alysophil, Bruker and Novalix, has completed a pilot programme demonstrating continuous-flow production of active pharmaceutical ingredients (APIs) using integrated chemistry, real-time analytics and AI-enabled process control.

The platform aims to address challenges linked to traditional pharmaceutical manufacturing, including lengthy scale-up processes, supply chain vulnerability and dependence on large centralised production facilities.

Continuous manufacturing combines chemistry and AI monitoring

Traditional pharmaceutical ingredient production typically relies on batch manufacturing, where materials are produced in separate stages and processes must undergo extensive validation before reaching commercial scale.

The PIPAC platform uses continuous-flow chemistry, advanced analytical monitoring and automated control systems to allow pharmaceutical compounds to be produced and assessed continuously throughout the manufacturing process.

The consortium validated the approach through continuous-flow production of fentanyl, a highly regulated active pharmaceutical ingredient. The demonstration was designed to show that the technology could operate under challenging manufacturing conditions and provide a basis for future applications across other pharmaceutical ingredients.

Alysophil developed AlchemDrive, an AI-based process-control platform that analyses production data and adjusts manufacturing parameters in real time.

Technology could support more flexible supply chains

The consortium said continuous manufacturing could enable smaller, modular production units that may support more distributed manufacturing approaches.

Unlike conventional batch production, continuous manufacturing allows quality and process performance to be monitored during production, potentially reducing scale-up risks and improving resource efficiency.

The approach is gaining interest as pharmaceutical companies and governments look for ways to strengthen medicine supply chains and reduce reliance on concentrated manufacturing capacity.

Consortium targets future GMP deployment

The project brings together expertise across pharmaceutical synthesis, analytical technology and industrial engineering.

Novalix developed the continuous-flow synthesis process, while Bruker provided analytical technologies for real-time monitoring. De Dietrich developed the industrial hardware and automation architecture required to integrate the platform.

The consortium said the technology could eventually be expanded to include additional manufacturing steps such as filtration, purification and drying, supporting the development of more integrated pharmaceutical production systems.

Frédéric Guichard, group executive director at 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.”

Guichard added: “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.”

The consortium said the pilot programme provides a foundation for developing future GMP-compatible continuous manufacturing systems.