ARTICLES BY BIOPHORUM
-
Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring7/22/2026
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
-
Managing The Presence Of Visible Particulates In Cell Therapies7/10/2026
Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls.
-
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.
-
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.
-
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.
-
Quantifying Single-Use Waste Produced During mAb Manufacture4/2/2026
Discover 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.
-
Navigating GMP Biosafety Challenges In ATMP Manufacturing3/26/2026
BioPhorum'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.
-
SUS Interchangeability Assessment And Qualification Best Practices3/12/2026
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
-
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.
-
Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing12/15/2025
How 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?