Incorporating digitalization in the conceptual design, research and development of plasmid biomanufacturing

The importance of large-scale production of plasmid DNA (pDNA) has increased steadily over the years due to the development of a growing number of direct and indirect applications. To meet the growing demand for pDNA, significant efforts must be made towards improving its manufacturing. In particular, the digitalization of pDNA manufacturing could enable faster process optimization, support data-driven decision-making, and contribute to waste reduction and more sustainable operations. In this commentary article, we further contend that the benefits of digitalization should be captured early on at the research and development stage of the manufacturing process. To support this vision, we present a conceptual framework for incorporating digitalization into pDNA process development, discuss technological enablers, explain how digital methods could overcome traditional limitations, and delve into implementation considerations.