Analytical and bioanalysis
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Analytical and bioanalysis
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.
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.
ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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.
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.
ReportPharma Horizons: the future of cell and gene therapy
This exclusive report addresses the key challenges and breakthroughs shaping the future of cell and gene therapy, from QC and analytical development to advanced manufacturing strategies. 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.
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.
EventPharmaLab Congress 2025: advancing pharmaceutical quality and innovation
The 2025 PharmaLab Congress offers a diverse programme with insights on the latest advances in analytical and microbiological quality control in the pharmaceutical industry.
ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
ArticleAre we set for the revised EU GMP Annex 1?
This blog is a summary of the key changes of relevance to primary packaging components seen in the latest iteration of EU GMP Annex 1.
ArticleSFC-MS: advancements and applications in pharmaceutical quality control
Modern supercritical fluid chromatography systems coupled with mass spectrometry are empowering pharmaceutical QC laboratories. Here, analytical experts from the University of Liège discuss applications from impurity and nitrosamines detection to purity analysis.
VideoWebinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard.
ArticleICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
ArticleAdvancements and knowledge gaps in ICH Q2(R2)
In this article, experts from USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. They highlight areas that would benefit from additional guidance and compare how the latest ICH Q14/Q2(R2) guidelines align with US pharmacopeial approaches.
ArticleAdvancing pharmaceutical technology: trends and innovations at ACHEMA 2024
Taking place in Frankfurt, Germany on 10-14 June, ACHEMA 2024 is expected to bring together chemists, engineers and process technicians from across the pharmaceutical and other industries.
ArticleSafeguarding purity under pressure: detecting nitrosamine contamination
In this article, analytical chemist Venkata Ranga Rao Attaluri explores the ongoing challenges posed by nitrosamine contamination in pharmaceuticals, highlighting the importance of robust and sensitive analytical detection methods.
ArticleUnlocking innovative hydrogel treatments
Researchers from Queen's University Belfast, Garry Laverty, Sreekanth Pentlavalli and Yuming An, delve into the potential of an innovative ‘hydrogel’ version of the HIV drug zidovudine.
VideoWebinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the ...
ArticleCoherent Raman scattering microscopy: a powerful tool for pharmaceutics
Coherent Raman scattering (CRS) microscopy is a powerful label-free technique that enables high-speed imaging of a sample’s chemical composition. Here, Raman experts Giulio Cerullo and Matteo Negro discuss how technological advances in the field can boost the broad applicability of CRS microscopy, as both an analytical tool for online monitoring ...
ArticleProcess analytics for the new era of continuous RNA manufacturing
In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line process analytic technologies (PAT), automation and real-time data analytics ...
ArticleValidation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
ArticleAnalytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum ...
VideoVideo: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and ...
ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
ArticleChallenging applications of capillary electrophoresis in biopharmaceutical analysis
After decades of development and refinement, the separation of proteins by capillary electrophoresis (CE) has moved beyond the R&D laboratory into the manufacturing quality control laboratory. This article discusses the advancements in CE technology for development applications and batch release for biopharmaceutical products.