Guide 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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In this Guide to Testing, articles explore method validation for endotoxin testing and using advanced chromatography solutions for analytical laboratory applications.
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.
The method offers an alternative approach for efficient control in affinity chromatography as a separation technique, researchers propose.
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.
20 May 2025 | By US Pharmacopeia
Join this webinar to learn about the essential role of Reference Standards in mitigating risks to pharmaceutical quality.
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.
12 May 2025 | By Mettler Toledo
Join this virtual panel to learn about impurity control in pharmaceutical waters, the differences between microbial and organic contaminants, and best practices for measurement and treatment.
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.
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.
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
The paper highlights a new analytical method that provides potential for sustainable use of nanomaterials and unique benefits compared to other spectrofluorimetric techniques.
4 February 2025 | By
Join to explore advanced analytical procedures to handle complex drug analytics and evolving regulations for development and quality control.
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
3 February 2025 | By ACD Labs
Learn about available formats for analytical data standardization, limitations, and how to ensure data is usable by lab scientists and AI/ML.
The spectroscopy-based study highlights the importance of integrating data-driven approaches to enhance isomer discrimination.