ARTICLES BY BIOPHORUM
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Improving Execution Of Biological Evaluation Of Drug Delivery Devices6/3/2026
This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.
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Rethinking CQV In A Digital, Agile Manufacturing Landscape5/21/2026
While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.
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Closing The MES Value Gap: Why Technology Isn't The Problem5/14/2026
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 Starts5/6/2026
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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MES Is Still In The CD ROM Era But The Data Architecture Has Moved On2/20/2026
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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Improving Drug-Device Combination Product Co-Development8/8/2025
Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated.