When Is an In Silico Representation a Digital Twin? A Biopharmaceutical Industry Approach to the Digital Twin Concept.

Digital twins (DTs) are expected to render process development and life-cycle management much more cost-effective and time-efficient. A DT definition, a brief retrospect on their history and expectations for their deployment in today's business environment, and a detailed financial assessment of their attractive economic benefits are provided in this chapter. The argument that restrictive guidelines set forth by regulatory agencies would hinder the adoption of DTs in the (bio)pharmaceutical industry is revisited, concluding that those companies who collaborate with the agencies to further their technical capabilities will gain significant competitive advantage. The analyzed process development examples show high methodological readiness levels but low systematic adoption of technology. Given the technical feasibilities, financial opportunities, and regulatory encouragement, concerns regarding intellectual property and data sharing, though required to be taken into account, will at best delay an industry-wide adoption of DTs. In conclusion, it is expected that a strategic investment in DTs now will gain an advantage over competition that will be difficult to overcome by late adopters.