news
New working party to address excipients in Ph. Eur. monographs
The European Pharmacopoeia Commission’s new Excipients Strategy Working Party will address specificities of excipients in European Pharmacopoeia monographs.
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QA/QC
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Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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Press release: Biopharmaceutical testing capabilities increasing in Switzerland
SGS have relocated their biopharmaceutical testing laboratory in Plan-les-Ouates, Switzerland.
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Computed tomography for in-depth investigation of freeze-dried products
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.
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Product hub: GMP ready: Ultrapure water, passcode access, validation support and TOC verification
Reliable, intuitive and simple to use. Bringing ELGA's ultrapure water purification to GxP Quality Control Laboratories.
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Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
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NITROSAMINES: Where now?
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.
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Brochure: The Caliber Manufacturing Suite – CaliberBRM
CaliberBRM is a manufacturing product suite that digitalises and automates pharmaceutical manufacturing processes for a paperless, future-ready lab.
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Application note: Rapid identification of Polysorbates 20 and 80 through amber bottles
How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.
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Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
news
Collaboration to support quality production of biologics
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.
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Taking advantage of protein charge properties for challenging separations
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.
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Article: The importance of real-time nanoparticle size analysis
The NanoFlowSizer, unique inline nanoparticle size analyser, is able to monitor nanoparticle suspensions and enable real time monitoring of processes.
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Challenges in pharmaceutical microbiology: looking to the future
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
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Shining a light on Raman for microbiological analysis
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…
