Abstract
The rise of personalised and highly complex drug product profiles necessitates significant advancements in pharmaceutical manufacturing and distribution. Efforts to develop more agile, responsive, and reproducible manufacturing processes are being combined with the application of digital tools for seamless communication between process units, plants, and distribution nodes. In this paper, we discuss how novel therapeutics of high-specificity and sensitive nature are reshaping well-established paradigms in the pharmaceutical industry. We present an overview of recent research directions in pharmaceutical manufacturing and supply chain design and operations. We discuss topical challenges and opportunities related to small molecules and biologics, dividing the latter into patient- and non-specific. Lastly, we present the role of process systems engineering in generating decision-making tools to assist manufacturing and distribution strategies in the pharmaceutical sector and ultimately embrace the benefits of digitalised operations.
Highlights
Processes 2021, 9, 457. https://Complexity in pharmaceutical manufacturing and distribution is highly dependent on the product nature
Pharmaceutical products have evolved towards disease- and patient-specific therapeutics, involving meticulous manufacturing steps
Increased drug specificity and demand uncertainty are adding a further level of complexity when it comes to the design and operation of robust manufacturing processes and distribution networks
Summary
Complexity in pharmaceutical manufacturing and distribution is highly dependent on the product nature. On the other hand, manufacturing of biologics involves cellbased production systems and complex downstream separation trains, largely performed in batch/semi-batch mode [2,3] This often presents challenges in the optimisation and scale up of unit operations. Their production process differs significantly from small molecules or mAbs as it involves a series of product- and often patient-specific steps [4] Their patient-specific nature may challenge scale up and distribution and has led to a shift in the manufacturing and supply chain status quo, highlighting the need for smaller, more agile, and often regional manufacturing units that translate into distributed networks closer to the patient. The term Pharma 4.0 has been introduced, referring to the adaptation of digital strategies and tools of Industry 4.0 principles, and their application to pharmaceutical manufacturing and supply chain practices [5,6]. Pharma 4.0 either through the development of digital platforms to be used by manufacturers (e.g., Siemens) or by integrating digitalisation into their manufacturing processes (e.g., ChemeCon GmbH) [8]
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