ARTICLES BY BIOPHORUM
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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.
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![Smart industry robot-GettyImages-1279628514]( "A Practical Guide To Defining Priority Data In MES")
A Practical Guide To Defining Priority Data In MES3/17/2025Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.
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![Document-GettyImages-507492447]( "Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data")
Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data1/23/2025The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.
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![Planning productivity-GettyImages-1489661764]( "A Justification For Using In-Process Controls In Place Of Cleaning Validation")
A Justification For Using In-Process Controls In Place Of Cleaning Validation1/9/2025This article provides a procedure for using and cleaning shared columns and column packing equipment and using in-process controls that eliminate the need for cleaning validation.
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![iStock-649107516]( "A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS")
A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS11/8/2024How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
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![image001-(5)]( "A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies")
A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies10/2/2024This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.
