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In this article, Teresa Siegert and Henning Gieseler, discuss the benefits of applying computed tomography in the production of freeze-dried pharmaceutical products, as well as the hurdles that must be navigated to realise its potential.
Reliable, intuitive and simple to use. Bringing ELGA's ultrapure water purification to GxP Quality Control Laboratories.
Here, Mark Dickman, Professor in Bioanalytical Science and Engineering at the University of Sheffield, explores how analytical techniques such as liquid chromatography-mass spectrometry can support the manufacturing of mRNA therapeutics.
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
An all in-one system purpose-built for rapid deployment, ease of use and scalability in markets where time-to-results is critical.
A key issue faced in pharmaceutical laboratories is the integration and standardisation of data from the array of instruments. Here, Samantha Kanza from the University of Southampton outlines some challenges with using laboratory information management systems or other digital tools. How might these be overcome?
Process mass spectrometers as process analytical technology (PAT) tools have been used for decades to monitor gas stream composition in and out of fermentors with precision.
How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
In this article, Mareia Frost, Scientific Leader at Abzena, explores how understanding the characteristics of protein‑based drugs, and applying the right techniques, means even the most complex biologics can be effectively separated from potentially-harmful impurities.
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail some…
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
The detection and identification of bacteria is essential for biopharmaceutical production, the assessment of new antimicrobials and assessing contamination control measures. Developing methods for complex environments is challenging due to interference from the various molecules present. Here, pharmaceutical microbiologist and contamination control expert Dr Tim Sandle explains how Raman spectroscopy…
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
