The Rocky Road to a Digital Lab.

Area of Science:

• Pharmaceutical Manufacturing
• Chemical Engineering
• Process Chemistry

Background:

• The pharmaceutical industry is transitioning towards continuous manufacturing for active pharmaceutical ingredients (APIs).
• Digitalization, process analytical technology (PAT), and data-rich experimentation are key enablers for smart manufacturing.
• Early-stage implementation of these technologies is crucial for efficient development.

Purpose of the Study:

• To present key aspects of implementing automated flow chemistry reactor platforms with real-time process analytics.
• To highlight the potential of these platforms for accelerating smart manufacturing routes.
• To showcase capabilities such as self-optimization and automated model building.

Main Methods:

• Implementation of automated flow chemistry reactor platforms.
• Integration of real-time process analytical technology (PAT).
• Utilizing digitalization and data-rich experimentation.

Main Results:

• Demonstrated the feasibility of automated flow chemistry for API synthesis.
• Showcased the ability of platforms to perform self-optimization and automated reaction model building.
• Highlighted the potential for implementing advanced process control strategies.

Conclusions:

• Automated flow chemistry platforms with real-time analytics are pivotal for smart pharmaceutical manufacturing.
• These systems facilitate accelerated development and optimization of synthetic routes.
• The integration of digitalization and PAT enables more efficient and controlled API production.