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Novartis has suspended production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey as it addresses potential quality issues identified in its manufacturing processes.
The International Society for Pharmaceutical Engineering (ISPE) has published the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms, in a bid to increase uptake.
Winners of ISPE's Facility of the Year Awards (FOYA) 2022 include Janssen, Takeda, CRISPR Therapeutics, Catalent and Iovance Biotherapeutics.
Following a successful pilot in 2021, Sanofi and McLaren Racing have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies.
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
A recent empirical study of continuous manufacturing (CM) versus batch processing of US and non‑US pharmaceutical manufacturing facilities suggests that CM would be more economical than batch facilities, at least for the production of oral solid dosage products. This has significant consequences for policies and strategies to reduce supply chain…
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
Could ELGA’s PURELAB® Pharma Compliance reliable, intuitive and simple to use GMP ready system be the future for your ultrapure water needs?
The facility is designed around a central unit that comprises several fully digitalised modules, which can produce up to four vaccines simultaneously, regardless of the vaccine technology used.
The scale up in annual capacity and expansion of Achilles' global clinical manufacturing footprint will see its second site in the UK and first site to be established in the US.
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
Edward Samuel, EVP Technical Operations at Achilles Therapeutics, explains why industrialised manufacturing and scale-up of autologous cellular immunotherapies will require fully closed systems and process automation.
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-300x278.jpg)
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-e1650536525880.jpg)
After first payment of $1bn to Biogen, Samsung Biologics has now fully acquired Samsung Bioepis.
