All Impurities, contaminants and nitrosamines articles
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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.
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NewsNanofiltration study highlights next-generation water treatment process
The technology could offer defect-free, high-efficiency ceramic-based water filtration through ultra-precise control of nanopores and surface structure.
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NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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NewsNovel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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News
Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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NewsNovel analytical approach could aid quality control during nitrosamine analysis
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
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NewsIn-line pharma monitoring system developed for tablet quality inspection
The novel approach could enhance quality testing applications in pharmaceutical manufacturing.
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NewsPharmacopeial Discussion Group releases major particulate contamination update
Revisions to the harmonised general chapter “Particulate Contamination (Q-09)” aim to improve pharmaceutical drug development.
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News
ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
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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.
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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.
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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.
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NewsOptimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
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NewsEU Urban Wastewater Treatment Directive may compromise EU medicine availability
The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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NewsNew mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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ArticleMAS-100 Libra®: the future of continuous cleanroom monitoring
Microbiological monitoring is essential for pharmaceutical facilities. As regulatory standards tighten, especially in cleanroom classes A and B, the need for reliable, continuous monitoring has grown. The MAS-100 Libra meets these demands by combining traditional settle plate methods with advanced automation, improving efficiency and accuracy.
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ArticleUnderstanding endotoxin cartridge testing: frequently asked questions
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
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NewsDownstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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NewsEuropean Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.