ARTICLES BY BIOPHORUM
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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.
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![China Flag Symbol-GettyImages-961226308]( "Import Product Specifications And Drug Registration Testing For China")
Import Product Specifications And Drug Registration Testing For China10/6/2025This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).
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![workers in lab wearing protective gear-GettyImages-1417392226]( "Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities")
Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities8/1/2025In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.
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![business analytics, data management, strategy-GettyImages-1408832606]( "A Road Map For PAT Monitoring And Control")
A Road Map For PAT Monitoring And Control5/8/2025Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
