Dear colleagues,
USP has published a new Stimuli article, "Digital Twin-Enabling the Future of Development and Manufacturing of Pharmaceutical and Biopharmaceutical Products with Standardization and Consistency."
The article discusses the potential role of Digital Twins in pharmaceutical and biopharmaceutical development and manufacturing, including process understanding, optimization, risk mitigation, and regulatory considerations. It also highlights the importance of standardization and consistency as the industry moves toward broader adoption of Digital Twin technologies.
📅 Comment deadline: September 30, 2026
🔗 USP Stimuli Article: https://doi.usp.org/USPNF/USPNF_S203684_10101_01.html
It is good opportunity for all of us interested in this area to review the article and submitting comments to USP, particularly around practical implementation, terminology, standardization, validation/credibility, data requirements, and regulatory considerations for Digital Twins in pharmaceutical applications.
Thanks,
Bhasker Sambar
Secretary, AAPS Regulatory Science Community
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Bhasker Sambar
Sr. Manager, External R&D and Technical Services
Alvogen INC
Exton PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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