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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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Manufacturing
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Teva appoints Eric Hughes as head of R&D and Chief Medical Officer
Dr Eric Hughes will join Teva as Executive Vice President, Global R&D and Chief Medical Officer in August, assuming the role from Dr Hafrun Fridriksdottir, who has been with Teva for 25 years.
whitepaper
Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
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WuXi Biologics launches cGMP microbial products facility in Hangzhou
China’s WuXi Biologics - a contract research, development and manufacturing organisation (CRDMO) - has launched a facility in Hangzhou for cGMP manufacturing of microbial-derived products.
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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.
whitepaper
ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
video
On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
article
Five areas in life sciences where data integrity is vital
Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need to ensure data integrity in life sciences. She explains how data integrity can reduce costs and increase patient safety across five key areas: reproducibility, IDMP, the microbiome, semantic enrichment, artificial intelligence and machine learning.
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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.
video
Webinar: Comparator sourcing success
Collaboration between comparator sourcing specialists and clinical supply managers can improve inventory management and supply chain performance.
article
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)
news
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.
