PharmSD 3.0 innovation project is focused on setting a new standard for continuous pharmaceutical manufacturing. By developing an end-to-end integrated spray-drying process, it unlocks new possibilities for more efficient, scalable, and cost-effective medicine production.

Facts about the project

• €7,119,785.35 - Total Budget
• €5,695,828.28 - EU Contribution (EU4Health Programme)
• 48 months - Project Duration
• 1st June 2025 - Start Date

The challenge 

The COVID-19 pandemic reinforced the need to increase the resilience of health systems by driving innovation in the production of critical medicines, reducing manufacturing bottlenecks, addressing emerging supply challenges, and advancing more sustainable solutions.

Spray Drying (SD) is one of the key technologies in pharmaceutical manufacturing to address drug solubility. While Spray Drying itself is a continuous unit operation, fully realizing the benefits of continuous manufacturing requires continuity across the entire process, from solution preparation to spray drying and ultimately secondary drying. 

Our ambition

As an innovative manufacturing solution, PharmSD 3.0 will offer a robust solution that unlocks the full potential of continuous manufacturing for Spray Drying, increasing the overall responsiveness during crises, and impacting patients worldwide that will benefit from faster access to critical medicines.

Our approach 

PharmSD 3.0 will develop a continuous solution preparation system to supply the SD, followed by a continuous secondary drying system to reduce residual solvent levels. These systems will be integrated in a continuous end-to-end solution through the development of advanced control systems, which will enable synchronous operation and Real-Time Release Testing (RTRT). In addition, the introduction of advanced detergents and a new recirculation cleaning system will shorten and improve the cleaning process and further increase Overall Equipment Effectiveness (OEE). 

Project outcomes 

PharmSD 3.0 will deliver an integrated continuous end-to-end process, representing a shift from traditional batch processes to continuous systems, ensuring the medicines of tomorrow are produced with:

• Enhanced supply chain flexibility
• Improved scalability
• Increased efficiency 
• Higher Overall Equipment Effectiveness (OEE) 
• Cleaning efficiency 
• Lower manufacturing costs 
• Increased sustainability

This project is Co-Funded by the European Union under the EU4Health Programme (EU4H) under Grant Agreement nº 101202523. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.