Articles in analytical and bioanalysis
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ArticleStrategies for scaling complex next-generation biologics
As biologic drug formats grow more sophisticated, scalable success depends on embedding manufacturability, analytics and quality thinking into molecular design from the very beginning of development.
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ArticleNitrosamines: from detection to understanding
Manufacturers are facing a new generation of nitrosamine challenges as NDSRIs demand more sophisticated analytical and risk management strategies.
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ArticleThe next frontier in nitrosamine testing: detection and risk assessment in packaging and IV infusion bags
Join Waters Corporation on the 23rd September for their webinar on the latest developments in nitrosamines testing, evolving regulatory expectations, analytical challenges, and advanced LC-MS/MS strategies for sensitive detection and risk assessment.
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ArticleTransforming mycoplasma testing for faster biotherapeutic quality control
As biotherapeutic manufacturing accelerates, rapid PCR-based methods are enabling manufacturers to detect mycoplasma contamination sooner. However, realising their full potential requires robust validation, risk-based implementation and integration with a wider contamination-control strategy.
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ArticleUnlocking peptide permeability with high-throughput SFC-EPSA analysis
Permeability assessment remains a key challenge in peptide drug discovery. SFC-based EPSA analysis provides a practical way to evaluate exposed polar surface area, while combined PDA/MS detection and open-access workflows support reliable, high-throughput screening.
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ArticleClosing the last mile: the key to fully unlocking healthcare value in Europe
Giancarlo Benelli reflects on why Europe must capitalise on its strong innovative drug discovery infrastructure by shoring up the last mile and attracting clinical trials back to Europe’s healthcare systems.
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ArticleDay three preview: the Future of Bio/Pharma Analysis Virtual Summit 2026
Pharmaceutical manufacturing takes centre stage on Day three of The Future of Bio/Pharmaceutical Analysis Virtual Summit 2026 as speakers examine how digital technologies, artificial intelligence and advanced production methods are reshaping what is possible in the field.
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ArticleMultiNA II MCE-301: smarter nucleic acid analysis for the modern lab
Automation, precision, and sustainability – Shimadzu’s MultiNA II MCE-301 redefines microchip electrophoresis, delivering faster, greener, and more reliable DNA and RNA analysis for QA/QC and research laboratories alike.
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ArticleMore than recombinant – it’s recombinant cascade
Download this guide to learn how recombinant cascade reagents support the transition from traditional Limulus amebocyte lysate (LAL) testing while maintaining consistency, compliance and performance.
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ArticleFrom ‘What is it?’ to ‘What does it mean?’
A practical guide to interpreting microbial isolates during EMPQ and water system qualifications
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ArticleRaman spectroscopy market reaches $2.35bn driven by pharma
A recent market report projecting the combined NIR and Raman spectroscopy sector will reach $2.35 billion in 2026 underscores the rapid adoption of vibrational spectroscopy across biopharmaceutical manufacturing, with AI-enhanced Raman tools increasingly being deployed for real-time quality control.
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ArticleEuropean Pharmaceutical Review Issue 1 2026
EPR Issue 1 includes articles on manufacturing, drug delivery, environmental monitoring, analytical techniques and more.
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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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ArticleNavigating evolving clinical and regulatory expectations as mRNA outgrows its vaccine roots
Jianbo Diao, PhD, Director of Bioanalytical Services, WuXi AppTec, discusses the importance for mRNA therapy developers of adopting precise and flexible analytical strategies for future pipeline success.
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ArticleSimplified rAAV lysate purification for complex analytics of upstream samples
Bioprocess experts from Sartorius BIA Separations and BridgeBio Gene Therapy illustrate an approach with potential to expedite AAV upstream analytics and lower overall process development costs.
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ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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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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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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ArticleThe key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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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.