Articles in analytical and bioanalysis – Page 2
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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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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.
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ArticleEuropean Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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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.
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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.
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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.
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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.
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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.
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ArticleEuropean Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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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.
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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.
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ArticleFractionation, purification and downstream processing: the path to commercialisation
With increasing progress in the life sciences, we are now able to treat diseases that were previously deemed incurable. This progress, however, comes with new challenges due to the growing complexity of chemical and biotherapeutic products. Developing and manufacturing compounds of interest in a pure and stable form quickly and ...
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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 ...
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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 ...
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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.
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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 ...
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ArticleForward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control with high-performance analytical instrumentation
Poland-based Polpharma API relies on Waters analytical instrumentation for impurities method development and testing to meet the ever-evolving regulatory guidance around N-nitrosamines (nitrosamines) control in active pharmaceutical ingredients (API).
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ArticleEuropean Pharmaceutical Review Issue 1 2024
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.
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ArticleStreamlining bioprocessing for gene therapy
Adopting technological advances in upstream and downstream processes is vital to the gene therapy space, says Kai Lipinski, CSO at ReciBioPharm. Here he explores emerging technology trends and discusses how they can help to overcome key challenges facing gene therapy manufacturers.
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