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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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Drug Manufacturing
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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.
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Reducing human error with better technology
Cleanroom and laboratory managers need to collaborate to set their employees up for success. They must also be willing to review their procedures even when it seems an employee is responsible for an error.
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Heparin affinity chromatography promising for extracellular vesicle purification
Researchers find that heparin affinity chromatography (HAC) produces highly pure extracellular vesicles with greater recovery than existing purification methods.
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Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
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Guide to Data Integrity
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need for data integrity in life sciences and how costs can be reduced but patient safety increased, and Charles River showcase their services and how they stand…
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European Pharmaceutical Review Issue 3 2022
In this issue experts explore the development of targeted protein degradation drugs, how potential legislative changes may impact the EU and selecting the right downstream process for bi-specific antibodies. Also featured in this journal, how RMM can enable efficient shutdown recovery, five critical areas for data integrity in life sciences…
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WTO waives intellectual property rights for COVID-19 vaccines
According to IFPMA, the World Trade Organization decision to waive intellectual property rights for COVID-19 vaccines fails to tackle the biggest barrier to access: trade.
