Quality (philosophy)

Marketing

World Wide Web

Product (mathematics)

Biopharmaceutical

Process (computing)

Engineering

Philosophy

Cyber-physical system

Pure mathematics

Biology

Industry 4.0

Agile software development

Embedded system

Field (mathematics)

Systems engineering

Operating system

Computer science

New product development

Manufacturing engineering

Business

Genetics

Process management

Mathematics

Pharmaceutical industry

Epistemology

Emerging technologies

Pharmacology

Artificial intelligence

Geometry

Quality by Design

Medicine

Software engineering

Digital transformation

Processes

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.

Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review