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The biomanufacturing industry has now the opportunity to upgrade its production processes to be in harmony with the latest industrial revolution. Technology creates capabilities that enable smart manufacturing while still complying with unfolding regulations. However, many biomanufacturing companies, especially in the biopharma sector, still have a long way to go to fully benefit from smart manufacturing as they first need to transition their current operations to an information-driven future. One of the most significant obstacles towards the implementation of smart biomanufacturing is the collection of large sets of relevant data. Therefore, in this work, we both summarize the advances that have been made to date with regards to the monitoring and control of bioprocesses, and highlight some of the key technologies that have the potential to contribute to gathering big data. Empowering the current biomanufacturing industry to transition to Industry 4.0 operations allows for improved productivity through information-driven automation, not only by developing infrastructure, but also by introducing more advanced monitoring and control strategies.

In this work, integrated process design and control of reactive distillation processes is considered through a computer-aided framework. First, a set of simple design methods for reactive distillation column that are similar in concept to non-reactive distillation design methods are extended to designcontrol of reactive distillation columns. These methods are based on the element concept where the reacting system of compounds is represented as elements. When only two elements are needed to represent the reacting system of more than two compounds, a binary element system is identified. It is shown that the same design-control principles that apply to a non-reacting binary system of compounds are also valid for a reactive binary system of elements for distillation columns. Application of this framework shows that designing the reactive distillation process at the maximum driving force results in a feasible and reliable design of the process as well as the controller structure. Topical Heading: Process Systems Engineering

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In this work, integrated process design and control of reactive distillation processes that involve multiple elements (more than two) is addressed through a computer-aided hierarchical decomposition-based framework. Multiple elements are encountered for reactive systems when four or more compounds (including inert compounds) are encountered. The reactive distillation design methods and tools which are similar in concept to design of binary non-reactive distillations and binary reactive distillations are used for design of multi-element reactive distillation processes, such as driving force approach. The methods that are used in this work are based on equivalent binary element concept. This concept provides the representation of a multi-element system in terms of two key elements, light key and heavy key elements. First, the reactive distillation column is designed using the equivalent binary element driving force approach. Next, through analytical, steady-state and closed-loop dynamic analysis it is verified that the control structure, disturbance rejection and energy requirement of the reactive distillation column is better than any other operation point that is not at the maximum driving force. Furthermore, it is shown that the design at the maximum driving force can be both controlled using simple controllers such as PI as well as advanced controllers such as MPC.

The contents of this article are based on the results of discussions the corresponding author has had since 2015 with the co-authors, who are members of academia and industry in Europe, on the scope and significance of chernical and biochernical engineering as a dis cipline. The result is a multi-layered view of chemical and biochemical engineering where the inner-layer deals with the fundamental principles and their application; the middle layer deals with consolidation and expansion of the principles through a combination of