Quality, microbiology and contamination control
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Quality, microbiology and contamination control
ArticleEuropean Pharmaceutical Review Issue 1 2026
EPR Issue 1 includes articles on manufacturing, drug delivery, environmental monitoring, analytical techniques and more.
ArticleHow to choose the right microbial air sampler
Microbial monitoring is an essential step for complying with GMP regulations in aseptic pharmaceutical manufacturing. For air monitoring, active air samplers must efficiently collect viable particles and be validated according to EN 17141 or ISO 14698 requirements. Efficiency can be determined by flow rate accuracy and sampling time, which together ...
Application noteSmart manufacturing and beyond: the Tri-Integrity and the support to quality management maturity for Industry 4.0.
Quality management in Industry 4.0 is becoming more data-driven and integrated across the product lifecycle. However, fragmented systems and limited visibility continue to make consistent performance difficult.
Application noteRobust, high-throughput automated solution for water endotoxin testing
Manual endotoxin testing workflows can introduce variability and restrict scalability in quality control laboratories. This application note examines how automated high-throughput systems address these challenges in water testing.
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Application noteAutomating ion chromatography for reliable routine analysis
Routine ion chromatography workflows are often time-consuming and manual, making efficiency and consistency difficult to maintain. This application note explores how automation can simplify IC workflows and support more reliable routine analysis.
ArticleEuropean Pharmaceutical Review Issue 1 (2026): Environmental Monitoring In-Depth Focus
This In-Depth Focus explores how BPCs, RMMs and AI-enabled analytics are being evaluated as a tool to enhance aseptic manufacturing, bioburden testing and monitoring.
ArticleFrom ‘What is it?’ to ‘What does it mean?’
A practical guide to interpreting microbial isolates during EMPQ and water system qualifications
ArticleTMSI: a novel, AI-driven alternative microbiological method for microorganism detection, enumeration and identification
Spore.Bio illustrates an AI-native, rapid microbiological method (RMM) that offers simultaneous viable quantitation and microbial identification capabilities suited to a range of applications including bioburden tests and environmental monitoring.
ArticleOptimising the downstream process in lentiviral vector manufacturing
Sartorius BIA Separations illustrates a promising alternative approach for efficient lentiviral vector purification that delivers a scalable, GMP-ready biomanufacturing solution.
ArticleApplying AI to enhance drug formulation and development
AI/ML is not replacing formulation scientists or process engineers; it is just amplifying their expertise.
ArticleEuropean Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
ArticleOptimising moisture and odour management in pharmaceutical packaging
This article answers some key questions about the need for environmental management in packaging, focusing on moisture and odour control, and the solutions available to achieve it.
ArticleMicrobiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
ArticleDrug development In-Depth Focus 2025
From groundbreaking cell and gene therapies to cost-effective drug delivery innovations, Europe is emerging as a hub for life-changing therapies. Explore expert insights and innovative solutions shaping the pharmaceutical industry.
ArticleGuide to Outsourcing 2025
Doug Botkin, PhD Scientific Portfolio Specialist from Charles River Laboratories, examines how modern microbial ID tools can enhance contamination control strategies and the benefits an outsourcing partner can provide.
ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
ReportPharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
ArticleAdvancing endotoxin testing with sustainable recombinant LAL solutions
Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
ArticleSupporting the pharmaceutical industry – how a CDMO can help
After their recent webinar, European Pharmaceutical Review’s Head of Content Ian Betteridge spoke with the team at Adragos Pharma to discuss the role of a CDMO and their importance in the fill and finish sector.
ArticleA rapid microbiological method case study for advanced therapy medicinal products
In this article, Stacey Ramsey, Senior Manager – Microbial Applications Lab, Charles River Laboratories, discusses the modernisation of rapid microbiological methods (RMMs) and the potential of ATP-bioluminescence when testing cell-based products.
ArticleGuide to Testing 2025
In this Guide to Testing, articles explore method validation for endotoxin testing and using advanced chromatography solutions for analytical laboratory applications.
PublicationEuropean Pharmaceutical Review Issue 2 2025
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
ArticleNew biosimilar pathways – key takeaways from the EMA’s draft reflection paper
Gain insight on the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
ReportPharma Horizons: environmental monitoring
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
ArticleQualification of non-mutagenic impurities (NMIs)
In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
ArticleAI-driven biomanufacturing: revolutionising production and quality in pharmaceuticals
This article explores how artificial intelligence (AI) is forming an essential pillar of staying competitive in pharmaceutical manufacturing, with its adoption ensuring greater efficiency of medicine production in this fast-evolving sector.
ArticleBeyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
ArticleEuropean Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.