ARTICLES BY BIOPHORUM
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![Checklist-GettyImages-695733892]( "Rethinking CQV In A Digital, Agile Manufacturing Landscape")
Rethinking CQV In A Digital, Agile Manufacturing Landscape5/21/2026While 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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![Reunification and accession-GettyImages-2168520923]( "Closing The MES Value Gap: Why Technology Isn't The Problem")
Closing The MES Value Gap: Why Technology Isn't The Problem5/14/2026Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
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![Mistakes To Avoid-GettyImages-1985714645]( "Why Your MES RFP Is Failing Before It Starts")
Why Your MES RFP Is Failing Before It Starts5/6/2026Many 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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![GettyImages-958709520]( "Quantifying Single-Use Waste Produced During mAb Manufacture")
Quantifying Single-Use Waste Produced During mAb Manufacture4/2/2026Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
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![Doctors diagnose DNA-GettyImages-2263111633]( "Navigating GMP Biosafety Challenges In ATMP Manufacturing")
Navigating GMP Biosafety Challenges In ATMP Manufacturing3/26/2026BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.
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![business change, transform-GettyImages-2252289373]( "SUS Interchangeability Assessment And Qualification Best Practices")
SUS Interchangeability Assessment And Qualification Best Practices3/12/2026Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
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![Old ways won't open new dorrs-GettyImages-696063644]( "MES Is Still In The CD ROM Era But The Data Architecture Has Moved On")
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On2/20/2026Many 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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![Quality Assurance GettyImages-466728721]( "Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing")
Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing12/15/2025How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?
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![Futuristic data-GettyImages-1325172964]( "How To Improve Sponsor–CMO Collaboration Around Digital Deviations")
How To Improve Sponsor–CMO Collaboration Around Digital Deviations11/17/2025Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.
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![Globe Direcrtion-GettyImages-483422997]( "Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs")
Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs11/6/2025This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.
