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Movement, speed and numbers: contribution of cleanroom operators to particle control
Tim Sandle explores the main factors that influence particle accumulation in pharmaceutical cleanrooms, advising how best to control risks and minimise operator contamination.
ArticleERA Pooling Project to support compliance with new environmental requirements
The German Pharmaceutical Industry Association has launched the ERA Pooling Initiative, a collaborative project enabling marketing authorisation holders to share environmental data, reduce duplicative testing and meet tightening regulatory requirements.
ArticleCHO perfusion model lifts yield by letting cellular waste build up
A hybrid model built into commercial software and running a self-driving bioreactor has found that unmeasured cellular waste, not the usual metabolites, throttles perfusion yields.
ReportPharma Horizons: Process Analytical Technology (PAT)
The definitive guide to transitioning from manual, offline batch testing to automated, continuous biomanufacturing.
News
NewsBioNTech appoints Guido Oelkers as new Chief Executive Officer
German biotech’s incoming leader set ahead of its goal of having multiple approved products by 2030.
NewsWHO proposes regulatory recommendations to support pharmaceutical decarbonisation
United Nations agency calls for coordinated action across the pharmaceutical value chain to align with existing regulatory practices that aid sustainable medicine innovation.
NewsTerahertz spectroscopy and machine learning accelerate API analysis
A new analytical approach combining terahertz spectroscopy with machine learning could support faster, non-destructive monitoring of active pharmaceutical ingredient content.
NewsJ&J wagers on next cell therapy frontier with $2.6bn Sail Bio acquisition option
In vivo-focused collaboration has scope to considerably boost therapeutic innovation and address unmet need in immune-mediated diseases.
From our partners
Ensuring drug quality: mastering stability testing in pharma
Join this webinar to discover how UV-Vis spectroscopy and gas chromatography support API monitoring, testing and analysis.
Pharma Horizons: Nitrosamines
EPR’s 2026 nitrosamines report covers the key developments in manufacturing, quality, regulation, analytical development and beyond.
Regulatory shifts ahead: preparing for EU pharmaceutical reform and FDA changes
With the EU’s pharmaceutical legislation reform soon to come into force, regulatory experts outline what is changing across both US and European frameworks and how sponsors can position pipelines ahead of implementation.
Opinion and interviews
Real-time Raman spectroscopy closes bioprocess control measurement gap
Manual sampling cycles leave bioreactor control decisions hours behind culture dynamics. Process Raman spectroscopy offers continuous, real-time measurement of critical parameters, enabling true closed-loop control in perfusion and continuous bioprocessing applications where measurement lag directly impacts yield and product quality.
Process Raman spectroscopy: closing biomanufacturing’s measurement infrastructure gap
The biopharmaceutical industry has embraced Pharma 4.0 concepts, but the measurement infrastructure required to realise autonomous facilities and continuous bioprocessing remains underdeveloped. Process Raman spectroscopy offers continuous, non-destructive monitoring at frequencies aligned with cell culture dynamics, bridging the gap between control system capabilities and available data.
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Regulatory shifts ahead: preparing for EU pharmaceutical reform and FDA changes
With the EU’s pharmaceutical legislation reform soon to come into force, regulatory experts outline what is changing across both US and European frameworks and how sponsors can position pipelines ahead of implementation.
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Ensuring drug quality: mastering stability testing in pharma
Join this webinar to discover how UV-Vis spectroscopy and gas chromatography support API monitoring, testing and analysis.
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Join this webinar to discover how modern QA/QC laboratories are embracing digital transformation to enhance compliance, workflows and data integrity to build a more connected, future-ready pharmaceutical quality ecosystem.
Implementing reporter assay-based MAT for rapid pyrogen detection
Regulatory shifts ahead: preparing for EU pharmaceutical reform and FDA changes
Ensuring drug quality: mastering stability testing in pharma
Modernising pharma QA/QC laboratories: preparing for a more connected, compliant future
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