news
‘Accidental’ media switch leads to CAR T therapy discovery
The investigators hope that their new approach could lead to large-scale manufacturing of the CAR T cells for blood cancer patients.
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Industry Insight
article
Botanical drugs – what is the best way forward for regulatory and market approval?
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
news
Optimising reverse-phase chromatography for molnupiravir production
The research offers insight into optimising chromatographic separation outcomes through precise control of measures such as flowrate and column length, supporting potential for drug development.
news
Digital simulations could advance nanoparticle drug delivery
Findings from the mathematical model could support development of personalised treatments, the research suggests.
news
CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
news
Innovative small molecule shows promise in obesity
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.
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.
article
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.
