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Digital Twin—Enabling the Future of Development and Manufacturing of Pharmaceutical and Biopharmaceutical Products with Standardization and Consistency

Douglas E. Kiehl, Desmond G. Hunt

Correspondence should be addressed to: Desmond G. Hunt, Senior Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; email: dgh@usp.org.

Digital twin technology represents a transformative approach to next-generation pharmaceutical and biopharmaceutical development and manufacturing, offering unprecedented capabilities for process optimization, risk mitigation, and regulatory compliance. By creating virtual replicas of physical assets, processes, and systems, pharmaceutical organizations can simulate, predict, and optimize operations in ways that were previously impossible. This article examines the current state of digital twin implementation in the pharmaceutical industry, explores key applications across the drug development life cycle, outlines strategic considerations, and identifies opportunities to establish standardization and consistency for successful and compliant adoption.

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