Dear MSE Community Members,
With the growing interest in AI and Digital Twin technologies across CMC and pharmaceutical manufacturing, I'm interested in learning how different organizations are implementing these models and preparing them for regulatory review. Many of us are navigating similar questions around credibility assessment, documentation expectations, lifecycle management, and alignment with evolving FDA guidance.
To help us gather insights in a structured way - and to make it easier to compile them into meaningful takeaways for the community - I've created a simple format below. If you're willing to share your experience, please feel free to use the same or a similar structure.
Example:
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Manufacturing Type: Sterile Injectables (Fill–Finish)
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AI / Digital Twin Model: Digital Twin for Fill Volume & Stopper Placement
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Key Manufacturing Challenges: Variability in fill accuracy
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Key Regulatory Challenges: Unclear expectations for credibility evidence
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Additional Comments: [Optional]
Thank you for sharing your insights.
Bhasker Sambar
Sr. Manager, R&D, Alvogen Inc.
[email protected]
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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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