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Microbial risks presented by aging facilities
Here, EPR summarises the microbial contamination concerns that may arise from aging facilities presented in an article by Tim Sandle.
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Drug Manufacturing
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What can we learn from contamination control failures?
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
![Sanofi logo on top of building [Credit: HJBC/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sanofi-1-300x278.jpg)
![Sanofi logo on top of building [Credit: HJBC/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sanofi-1.jpg)
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Sanofi launches Impact® brand of medicines for low-income countries
Sanofi Global Health — a nonprofit unit of Sanofi set up in 2021 — has launched Impact®, a new brand of standard of care medicines dedicated for nonprofit distribution in 40 of the world’s lower-income countries.
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Pfizer to reach carbon net-zero by 2040
Pfizer plans to reduce greenhouse gas emissions by 95 percent, moving away from fossil fuels to reach net-zero 10 years ahead of global target.
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Lonza to build €500m fill and finish facility in Stein
The large-scale commercial drug product fill and finish facility will be built at Lonza’s existing site in Stein, Switzerland, with completion expected in 2026.
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Controlling contamination by material transfer
Here, EPR summarises Tim Sandle's review of different methods for transferring items into aseptic areas, including decontamination chambers and pass-through hatches.
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How should cleaning validation sampling locations be chosen?
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
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The challenge of handling highly potent API and ADCs in analytical chemistry
Handling highly potent active pharmaceutical ingredients (HPAPIs) or drug product in a laboratory requires implementation of strict security measures. Here, Elodie Barrau and Olivia Jones discuss high potency product handling procedures to ensure continued safety.
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Biopharmaceutical bioseparation systems market to value $20bn
With demand for biopharmaceuticals rising and advances being made in bioseparation systems, the global market it expected to witness significant growth.
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Rapid method development to overcome challenges of bi-specific antibody purification
The landscape of biopharmaceutical manufacturing is changing, with complex molecules such as bi-specific antibodies (bsAbs) becoming increasingly prevalent. bsAbs are a large, structurally diverse family of molecules designed to recognise two targets and globally there are over 230 in development as promising therapies for cancer and other diseases. While they…
![Alexion Pharmaceuticals company logo displayed on a smart phone screen [Credit: IgorGolovniov/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Alexion-1-e1656323649599-300x278.jpg)
![Alexion Pharmaceuticals company logo displayed on a smart phone screen [Credit: IgorGolovniov/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Alexion-1-e1656323657672.jpg)
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Alexion to expand biologics manufacturing with €65m investment
The investment in new drug substance production equipment and warehousing facilities to enhance Alexion’s biologics manufacturing in Ireland.
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2022 spells change for EU pharmaceutical legislation
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
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BioNTech launches African vaccine production in Rwanda
Marking the initiation of its African vaccine manufacturing network, BioNTech begins construction of its hub site in Rwanda.
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Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
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Pharmaceutical C-suite update
With two knighthoods in the last month, here EPR discusses five developments in the drug development community’s C-suite.
