An integrated data management and informatics framework for continuous drug product manufacturing processes: A case...

Area of Science:

• Pharmaceutical Manufacturing
• Industry 4.0
• Data Integration

Background:

• The pharmaceutical industry is transitioning to continuous manufacturing and digitalization.
• Integrated data management and informatics tools are crucial for this shift.
• Industry 4.0 technologies are key enablers for process development.

Purpose of the Study:

• To guide the development of data integration for continuous pharmaceutical manufacturing.
• To improve digital maturity within the Industry 4.0 framework.
• To facilitate the creation of digital twins for pharmaceutical processes.

Main Methods:

• Demonstration of a data integration framework in academic pilot plants.
• Showcasing integration structures and information flows.
• Discussing approaches for complex data stream mitigation.

Main Results:

• Successful employment of the data integration framework in pilot plants.
• Comprehensive details on integration structure and information flow.
• Mitigation strategies for integrating diverse data sources and ensuring security.

Conclusions:

• The developed data integration framework enhances digital maturity in continuous pharmaceutical manufacturing.
• The framework supports the development of digital twins.
• Practical challenges and opportunities for Industry 4.0 implementation are identified.