Manufacturing 4.0 emphasizes obtaining and using data to gain knowledge about processes and product quality. Essential tools and technologies in this process environment focus on digitalization and process monitoring and control. In this report, BPI’s managing editor joins authors from Austria’s University of Natural Resources and Life Sciences (BOKU), Boston Consulting Group, Ireland’s National Institute for Bioprocessing Research and Training (NIBRT), and the United Kingdom’s University of Nottingham to explore strategies for hastening Manufacturing 4.0. Read on to learn more about the role of enterprise resource planning (ERP) systems in digitalization strategy, novel soft sensors and fluorescent nanosensors for real-time monitoring of bioprocess parameters, and advanced process control systems.


Designing the Right Strategy for Digital Transformation
James Morton (Boston Consulting Group, London, UK) and Killian O’Driscoll (NIBRT)

Many biopharmaceutical companies lack a coherent strategy for transitioning operations to Manufacturing 4.0. Morton and O’Driscoll highlight the benefits and value opportunities of digital transformations and present a straightforward roadmap for biomanufacturers to implement such transformation. Critical steps include building personnel training, maintaining communication, and bringing regulatory clarity. Finally, the authors discuss collaborative projects among the Biopharma 4.0 (B4.0) Alliance, Boston Consulting Group, and NIBRT.

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Fluorescent Nanosensors:
Real-Time Biochemical Measurement for Cell and Gene Therapies
Veeren M. Chauhan (Bioinspired Therapeutics, Advanced Materials & Healthcare Technologies, School of Pharmacy, University of Nottingham)

Fluorescent nanosensors allow real-time monitoring of key biochemical parameters that are unmeasurable by any other methods. These novel sensors can perform silent measurement of key biochemical parameters with high spatial and temporal resolution. The author herein discusses up-and-coming applications of this emerging technology in biopharmaceutical manufacturing, including subcellular and whole-organism analytics.
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Soft Sensors for Bioprocess Monitoring
Brian Gazaille, with Benjamin Bayer (Institute of Bioprocess Science and Engineering, BOKU; Novasign)
Application of soft sensors for industrial process monitoring is relatively new in the biopharmaceutical industry. Most applications so far have focused on leveraging different software packages and mathematical models to assess biomass concentrations and growth rates. BPI’s associate editor spoke with Benjamin Bayer to learn more about current and potential applications of soft sensors in bioprocess monitoring of different process parameters.
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Developing Process Control Strategies for Continuous Bioprocesses
Maribel Rios, with Christoph Herwig (exputec and Vienna University of Technology), Peter Satzer (Austrian Center of Industrial Biotechnology), and Lisa Graham (Seeq)

Continuous bioprocesses should exhibit high performance and product quality consistently, especially at commercial scales. Ensuring that requires appropriate control strategies of process inputs and outputs (e.g., performance-based strategies or an ICH Q12 approach). In this article, three experts discuss their approaches for implementing process control of continuous and perfusion systems, including use of digital twins, advanced software solutions, and multivariate analysis of process parameters.
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Challenges and Benefits of Networking Process Control Manufacturing Systems
Richard Holowczak and Jim Furey (PendoTECH)

Networking manufacturing process control systems can increase facility efficiency and productivity, leading to lower cost of goods (CoG). But integrating manufacturing systems with manufacturing execution systems (MESs) upward to an enterprise resource planning (ERP) business system can improve organizational
efficiency even further. Herein, representatives from PendoTECH explain how an ERP system can optimize intrafacility manufacturing resources.
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