PIPAC, a European consortium comprising industrial equipment provider De Dietrich, process automation company Alysophil, analytical technology supplier Bruker, and contract research organization Novalix, has completed a pilot program validating a continuous manufacturing platform for active pharmaceutical ingredients (APIs).

The platform integrates continuous-flow chemistry, real-time analytical monitoring, and automated process control to enable pharmaceutical compounds to be produced and optimized continuously rather than through traditional batch processes.

The consortium validated the technology through the continuous-flow production of fentanyl, a highly potent and tightly regulated API. According to the consortium, the demonstration showed the platform’s ability to operate under demanding manufacturing conditions and could serve as a foundation for producing additional pharmaceutical ingredients using the same approach.

The platform combines technologies from each consortium partner. Novalix developed the continuous-flow synthesis route, while Bruker supplied analytical tools for continuous, real-time process measurement and monitoring. Alysophil provided an AI-driven process control system that analyzes production data and adjusts manufacturing parameters in real time, according to the announcement. De Dietrich developed the industrial hardware and automation architecture that integrates synthesis, analytics, and process control into a scalable manufacturing environment.

The project was designed to address limitations associated with conventional batch manufacturing, which often requires extensive scale-up activities before production processes can be validated. Continuous manufacturing allows product quality and process performance to be monitored throughout production, enabling earlier process intervention and reducing scale-up risk, the consortium said.

The approach could potentially support smaller, modular manufacturing units and future decentralized production models aimed at strengthening regional pharmaceutical manufacturing capacity and supply chain resilience.

The pilot system also provides a foundation for future GMP-compatible continuous manufacturing operations, according to the consortium. The platform can be expanded to include downstream processing steps such as filtration, purification, and drying, creating a pathway toward fully integrated pharmaceutical production.