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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.
29 January 2025 | By European Pharmaceutical Review, sponsored by 908Devices and Bruker BioSpin
During this virtual panel, industry experts will explore the latest developments and biggest challenges in process analytical technology (PAT) today.
24 January 2025 | By LabVantage Solutions
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
24 January 2025 | By
Discover how Bruker Benchtop NMR integrates with synTQ software, enhancing process monitoring and complementing IR and Raman techniques in the PAT framework
Integration of industry 4.0 is anticipated to steer growth of the process spectroscopy market into the next decade, a report predicts.
The partnership will provide biotech companies with accelerated access to clinical development capabilities, including drug development and analytical services.
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
