Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review

Yingjie Chen,Marianthi Ierapetritou,Chaitanya Sampat,Ou Yang,Rohit Ramachandran,Pooja Bhalode

doi:10.3390/pr8091088

Yingjie Chen, Marianthi Ierapetritou + Show 4 more

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https://doi.org/10.3390/pr8091088

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Abstract

The development and application of emerging technologies of Industry 4.0 enable the realization of digital twins (DT), which facilitates the transformation of the manufacturing sector to a more agile and intelligent one. DTs are virtual constructs of physical systems that mirror the behavior and dynamics of such physical systems. A fully developed DT consists of physical components, virtual components, and information communications between the two. Integrated DTs are being applied in various processes and product industries. Although the pharmaceutical industry has evolved recently to adopt Quality-by-Design (QbD) initiatives and is undergoing a paradigm shift of digitalization to embrace Industry 4.0, there has not been a full DT application in pharmaceutical manufacturing. Therefore, there is a critical need to examine the progress of the pharmaceutical industry towards implementing DT solutions. The aim of this narrative literature review is to give an overview of the current status of DT development and its application in pharmaceutical and biopharmaceutical manufacturing. State-of-the-art Process Analytical Technology (PAT) developments, process modeling approaches, and data integration studies are reviewed. Challenges and opportunities for future research in this field are also discussed.

Highlights

Competitive markets today demand the use of new digital technologies to promote innovation, improve productivity, and increase profitability [1]
This paper aims to discerning summary of the current status of digital twins (DT)
DTs are a crucial development of the close integration of manufacturing information and physical resources that raise much attention across industries

Summary

Introduction

Competitive markets today demand the use of new digital technologies to promote innovation, improve productivity, and increase profitability [1]. The growing interests in digital technologies and the promotion of them in various aspects of economic activities [2] have led to a wave of applications of the technologies in manufacturing sectors. The advancements of digital technologies have initiated different levels of changes in manufacturing sectors, including but not limited to the replacement of paper processing with computers, the nurturing and promotion of Internet and digital communication [1], the use of programmable logical controller (PLC) and information technology (IT) for automated production [3], as well as the current movement towards a fully digitalized manufacturing cycle [4]. Smart technologies under the umbrella of Industry 4.0, such as the development of the IoT, big data analytics (BDA), cyber-physical systems (CPS), and cloud computing (CC) are playing critical roles in stimulating the transformation of current manufacturing to smart manufacturing [7,8,9,10]

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