article
API nitrosamines: method sensitivity issues
Here, David Elder discusses the risks presented by active pharmaceutical ingredient nitrosamines and explains how European and US guidance differs on their acceptable levels.
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Drug Manufacturing
article
Accelerating timelines for development and manufacture of multi-specific antibodies
The critical need to rapidly develop new biological therapeutics was emphasised during the COVID-19 pandemic, prompting a sea-change in the speed with which development of complex biological medicines occurs. In parallel, the increasing demand for new molecular formats, such as multi-specific antibodies, to tackle a wide range of disease modalities…
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546-300x278.jpg)
![Sandoz company logo on office building in Warsaw city centre [Credit: Konektus Photo/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Sandoz-2-e1661424920546.jpg)
news
Sandoz to become standalone company
A spin-off from parent company Novartis aims to set Sandoz up as the premier European generics company.
news
Blister material as a source of nitrosamine impurities
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
article
Efficient water determination accelerates API development
Contract development and manufacturing services for active pharmaceutical ingredients (APIs) must meet the requirements of customers and regulatory bodies alike. In the process control lab of the CARBOGEN AMCIS AG pilot plant in Bubendorf, Switzerland, accurate and efficient Karl Fischer titration workflows for water determination offer fast and reliable decision…
article
Towards ‘smart’ vaccine development and manufacturing
The coronavirus pandemic encouraged biopharmaceutical companies to adopt smarter approaches to vaccine development. Here, Vishnu Kumar and Soundar Kumara from Pennsylvania State University, and Vijay Srinivasan from National Institute of Standards and Technology (NIST), explore the emergence of platform-based vaccine technologies and their potential expansion to treat other life-threatening diseases.
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Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
podcasts
EPR Podcast Episode 12 – Digital twins in R&D – Loredana Vagaggini, GSK
Tune in to discover how and why digital twins are being developed and used in pharmaceutical development and manufacturing.
article
European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
news
$6mn grant to advance purification membranes for viral vectors
With the grant, researchers will create a scalable, downstream purification platform that will replace the standard processes, accelerating viral vector production for vaccines.
news
Common pharma compliance concerns cited by FDA warning letters
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
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Trends in biopharma contract manufacturing 2022
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
news
UNICEF signs first ever malaria vaccine supply contract with GSK
Securing 18 million doses of GSK’s RTS,S malaria vaccine, UNICEF calls the contract a major breakthrough for child health.
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Pharma contract manufacturing market to grow to $130bn by 2026
Growth in the global pharmaceutical contract manufacturing market will be driven by rising consumption of medicines and increasing commercialisation of generic and innovative therapies, among other factors.
![Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner Jr, Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Dr Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Dr Minzhang Chen, and others celebrating the groundbreaking for the WuXi STA Middletown campus [Credit: WuXi STA].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/WuXi-STA-groundbreaking-scaled-e1660730270899-300x278.jpeg)
![Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner Jr, Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Dr Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Dr Minzhang Chen, and others celebrating the groundbreaking for the WuXi STA Middletown campus [Credit: WuXi STA].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/WuXi-STA-groundbreaking-scaled-e1660730270899.jpeg)
news
WuXi STA breaks ground on new Delaware manufacturing facility
The new 190-acre pharmaceutical manufacturing campus will provide formulation development, clinical and commercial drug product manufacturing services.
