FEATURED ARTICLES
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Tobias Struller, Manager, Process Performance & Qualification
Tobias provides insight into the challenges of manufacturing cytotoxic and noncytotoxic drugs together in a multiproduct facility.
WHITE PAPERS & CASE STUDIES
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Vaccine Fill Line Operations
Learn how adopting a harmonized, risk-based validation strategy across global sites can reduce operational readiness timelines and drive improvements in equipment effectiveness and regulatory compliance
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GMP Manufacturing Cycle Time Reduction
Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.
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Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination
Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.
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Contamination In The Shadows: Risks Lurking From Environmental Issues
Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.
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Ringing The Alarm: Unified Data For GMP Annex 1 Compliance
Alarm monitoring can be more than compliance. Learn how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.
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Build An AAV8 Platform: Lessons From A Collaborative Development Journey
Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.