Industry Perspectives
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Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
7/8/2026
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
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Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains
6/19/2026
Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.
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The Need For Speed: Is Your Medtech Supply Chain Ready For The Next Disruption?
5/22/2026
In a recent Deloitte Center for Health Solutions survey, 68% of medtech leaders said they lack confidence in their companies’ ability to restore disrupted supply chains quickly. Here are key practical action items to take.
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Closing The MES Value Gap: Why Technology Isn't The Problem
5/14/2026
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
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Why Your MES RFP Is Failing Before It Starts
5/6/2026
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
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Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
4/17/2026
Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.
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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
2/20/2026
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
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New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
1/29/2026
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
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The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
1/21/2026
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
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Why Use Total Organic Carbon Analysis For Cleaning Validation?
1/21/2026
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.