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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…
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.
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…
Tune in to discover how and why digital twins are being developed and used in pharmaceutical development and manufacturing.
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,…
With the grant, researchers will create a scalable, downstream purification platform that will replace the standard processes, accelerating viral vector production for vaccines.
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.
As biopharmaceuticals become an increasingly important part of the drug development pipeline and market, EPR discusses key trends in the outsourcing of their manufacturing.
Securing 18 million doses of GSK’s RTS,S malaria vaccine, UNICEF calls the contract a major breakthrough for child health.
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)
The new 190-acre pharmaceutical manufacturing campus will provide formulation development, clinical and commercial drug product manufacturing services.
Here AMR Industry Alliance representatives Melissa Gong Mitchell and Steve Brooks discuss how the Alliance is mobilising the life sciences sector in combatting antimicrobial resistance (AMR). They present the newly established antibiotics manufacturing standard that aims to minimise pharma’s contribution to AMR in the environment, considering the critical considerations and…
SGS’s CDMO Quay Pharma awarded UK’s highest accolade for business success in overseas sales, Queen's Award for Enterprise: International Trade.
With vaccination programmes fighting to recover after the pandemic fuelled the “largest backslide” in three decades, GSK says manufacturing challenges will leave a shortage of rotavirus vaccines.
The Frost & Sullivan Institute to present CDMO Samsung Biologics with a Global Enlightened Growth Leadership Award for its commitment to sustainable growth and protecting and prolonging human lives.
