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Manufacturing
news
Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
news
Advancing autonomous API reaction optimisation
A novel flow reactor platform was able to self-optimise a range of variables within a multi-step reaction by leveraging process analytical technologies (PAT) and chemometric models.
whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
article
Personalised culture media solutions support timely biopharmaceutical manufacturing
FUJIFILM Irvine Scientific excels in facilitating improved upstream cell culture and process development for the production of therapeutic proteins with custom media. Here, Burga Kalz-Fuller, Product Manager for Custom Media Services at FUJIFILM Irvine Scientific, answers frequently asked questions about personalised cell culture media solutions.
news
Non-viral CRISPR could overcome cell and gene therapy bottlenecks
A new approach leveraging high-yield CRISPR could make it easier to re-engineer massive quantities of cells for therapeutic applications.
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.
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.
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.
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
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.
news
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.
