news
Lilly agrees $3.2b IBD acquisition
The acquisition, which has a value of approximately $3.2 billion, is set to support development of small molecule oral integrin therapies for conditions such as ulcerative colitis.
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Research & Development (R&D)
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.
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.
whitepaper
Advertorial: Next-generation microbial testing of pharmaceuticals
Specialised microbial testing is key in drug development to mitigate contamination risks, which threaten drug efficacy and patient safety. Bruker's MALDI Biotyper® at MPL, Austria, ensures accurate and robust testing, in a high-throughput workflow, delivering reproducible results.
whitepaper
Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
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
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.
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
Press Release: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
SGS’s Birsfelden, Switzerland lab is now a “one-stop shop” for biopharma firms in GMP/non-GMP analytics, featuring a new stability studies capability.
