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Process analytics 4.0: A paradigm shift in rapid analytics for biologics development
Dhanuka P Wasalathanthri1, Ruchir Shah1, Julia Ding1
1Global Process Development Analytics, Bristol-Myers Squibb Company, Devens, Massachusetts, USA.
Process Analytics 4.0 integrates advanced technologies like process analytical technology (PAT) and automation for biologics development. This framework enables real-time analytics, improving process understanding, agility, and sustainability in biopharmaceutical manufacturing.
Area of Science:
- Biopharmaceutical Process Development
- Analytical Chemistry
- Industrial Automation
Background:
- Biologics development faces challenges in analytical testing due to complex biomolecules.
- There is a need for advanced process analytics tools for rapid analysis.
Purpose of the Study:
- Introduce and define Process Analytics 4.0.
- Review key features of PAT, automation, and data management in biologics process development.
- Discuss business aspects and implementation challenges.
Main Methods:
- Literature review focusing on Process Analytical Technology (PAT), assay automation, and cyber-physical systems.
- Analysis of digitalization, automation, and real-time testing benefits.
- Examination of robotics, liquid handling, and data management systems.
Main Results:
- Process Analytics 4.0 combines technology (PAT, automation, IoT) with cyber-physical systems for real-time analytics.
- Digitalization and automation offer significant technological and business advantages.
- Robotics and automation enhance high-throughput testing capabilities.
Conclusions:
- Systematic PAT implementation enables real-time analytics for better process understanding and sustainability.
- Cyber-physical systems are crucial for data management within the Process Analytics 4.0 framework.
- Implementation challenges exist but yield substantial benefits in biopharmaceutical drug substance development.
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