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Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
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Manufacturing
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Whitepaper: Digital transformation of medical devices sterilisation by EtO
A new perspective of digital transformation in a terminal sterilisation process of medical devices such as syringes used for Covid-19 vaccination.
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Germany still second largest producer of EU-approved active biopharmaceutical substances, finds report
A new medical biotechnology report shows Germany’s biopharmaceutical industry is thriving with recombinant antibodies being a key focus area.
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Partnership to revolutionise RNA production
Under a strategic collaboration eTheRNA immunotherapies and Quantoom Biosciences will develop a novel, scalable RNA production system.
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Using software to improve data management and output in pharma development
The COVID-19 pandemic has exposed various issues with the software and data processes employed in the pharmaceutical industry and spurred rapid digital transformation at a rate never before seen in the sector. In this article, Jordan Stobaugh, Principal Research Scientist at AbbVie, discusses how software can improve data management and…
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The role of digital transformation in achieving Pharma 4.0
Pharma 4.0 represents the next step in the evolution of pharmaceutical manufacturing, and is heralded as providing manufacturers with better efficiencies, higher output and quality, as well as flexible production. Here, Dr Saly Romero-Torres highlights some of the key trends in digital transformation and explains why a strong informatics infrastructure…
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Application note: From our platforms to your pen injector
Nemera offers four product platforms for pen development and manufacturing. These include reusable and disposable devices which are designed for various therapies to meet key users’ needs.
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Article: Survey of the status of rFC and LAL equivalence determination
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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ICH M13: Bioequivalence guidelines
Dave Elder outlines how bioequivalence data supports numerous processes at various stages of drug development as well as when establishing generic drug substitution, and reflects on its differing interpretations across the globe.
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Trends in the vaccine contract manufacturing market
While we all know that COVID-19 has promoted growth in the vaccine contract manufacturing market, what other factors are impacting the field? In this article, EPR summarises the trends and opportunities identified by a new market research report.
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Manufacturing, Packaging & Logistics In-Depth Focus 2021
In this in-depth focus, find out about the key points to consider when implementing new software in the pharma development space and the current positions of the EMA and FDA with regards to nitrosamine contaminants.
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-300x278.jpg)
![The GlaxoSmithKline headquarters building in Brentford, west London, June 2018 [Credit: Willy Barton / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/GSK-3-e1624534468322.jpg)
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GSK to focus on vaccines and specialty medicines in next decade
In an investor update, GlaxoSmithKline (GSK) revealed its plan to promote growth and performance over next ten years.
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Global API market to value $300 billion by 2030
Researchers anticipate the growth of the aging population and rising investment in biologic drugs to promote the expansion of the global active pharmaceutical ingredient (API) market.
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Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
