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ERA 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.
ArticleLab 4.0 balance: connected, compliant and ready to integrate
Combining connectivity, compliance and automation, Lab 4.0 connectivity simplifies workflows, reduces manual intervention and supports secure digital transformation in modern pharmaceutical laboratories.
ArticleMovement, 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.
ReportPharma Horizons: Process Analytical Technology (PAT)
The definitive guide to transitioning from manual, offline batch testing to automated, continuous biomanufacturing.
News
NewsGenentech invests $750m in Oregon fill-finish expansion
Advances firm’s end-to-end drug manufacturing capabilities in the US, doubling the size of the existing facility at its Hillsboro, Oregon campus.
NewsMSD-Moderna Phase III readout backs personalised mRNA neoantigen combination adjuvant therapy for melanoma
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
NewsSK pharmteco expands HPAPI and small molecule capacity in Ireland
Opening of the two advanced manufacturing facility expansions strengthens the CDMO’s capabilities in large-scale commercial small molecule API production and HPAPI manufacture.
NewsMHRA sets out licensing pathway for microbiome-based medicinal products
The regulator’s new position paper provides developers with a defined regulatory route to licence microbiome-based medicinal products in the UK.
From our partners
Risks of non-compliance: managing impurity control and challenges with reference materials
Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Modernising pharma QA/QC laboratories: preparing for a more connected, compliant future
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.
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.
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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Upcoming Webinars
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Implementing reporter assay-based MAT for rapid pyrogen detection
Join this webinar to discover how reporter assay-based MAT can help laboratories accelerate pyrogen testing, simplify workflows and support the transition to animal-free testing while maintaining confidence in results.
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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.
Webinar
Risks of non-compliance: managing impurity control and challenges with reference materials
Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Webinar
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.
Webinar
Modernising pharma QA/QC laboratories: preparing for a more connected, compliant future
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
Risks of non-compliance: managing impurity control and challenges with reference materials
Ensuring drug quality: mastering stability testing in pharma
Modernising pharma QA/QC laboratories: preparing for a more connected, compliant future
On-demand Webinars
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