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US Pharmacopeia (USP) and American Type Culture Collection (ATCC) will collaborate to better support the biologics sector in R&D, process development and release of high-quality biologics.
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 NanoFlowSizer, unique inline nanoparticle size analyser, is able to monitor nanoparticle suspensions and enable real time monitoring of processes.
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, Ahmad Amini and Johan Carlsson from the Swedish Medical Products Agency discuss the use of matrix‑assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF MS) for identification of lithium in pharmaceutical preparations.
Technical Report 90: Contamination Control Strategy Development has been released by the Parenteral Drug Association (PDA).
In this Q&A Miriam Guest, Principal Microbiologist at AstraZeneca UK, discusses trends in bacterial endotoxin testing, as well as factors to consider when looking to implement rapid methods.
Articles explore analytical techniques for the analysis of mRNA therapeutics, computed tomography for characterisation of freeze-dried products and more...
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
Researchers have shown a combination of peracetic acid and ultraviolet light could improve microbial water quality in pharmaceutical water systems.
An innovative analytical platform based on liquid chromatography, mass spectrometry and software analysis can quantify the structure of mRNA-based medicines, researchers have found.
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
With manufacturing of essential medicines in Europe at risk, Teva’s Phillippe Drechsle looks at the action needed to stop further offshoring to Asia.
