article
Prodrugs: seeking perfection in an imperfect world
Balancing safety, efficacy and cost in drug development is challenging. Prodrugs offer potential solutions, but also introduce additional complexities, as Dave Elder explains.
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Biopharma
article
Continuous manufacturing: an evolving technology for drug substance manufacturing
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early 2000s that the technology caught the attention of the pharmaceutical industry in a significant way.
article
Combining biofermentation and chemical synthesis to manufacture complex molecules in pharmaceutical applications
It is well known that nature, being a rich source of bioactive natural products, offers up a massive number of candidate drugs for the pharmaceutical industry. David Blanco, Industrial BD and CDMO Director at Suanfarma CDMO, reveals why biofermentation benefits from additional processing to produce a viable drug candidate.
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Guide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
article
QA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
article
European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
news
New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
article
Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
news
New US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
news
New multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
news
Optimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
news
Gilead small molecule demonstrates strong capability for HIV prevention
According to Gilead, the study is the first Phase III HIV prevention trial to demonstrate a zero-infection rate.
news
Semi-automation of manual interventions in high-speed filling lines
Research has highlighted the potential of using robotics for isolator filling line interventions, enabling gloveless executions by operators.
article
Big potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about…
