Issue: Vol. 42

Novel purification strategies for lipid nanoparticles building blocks

Synthetic lipids have recently been used with great success in mRNA lipid nanoparticles (LNP) formulations, which has greatly increased their demand. Chromatography still remains a standard unit operation in the purification of these lipids. However, traditional normal phase chromatography often uses large amounts of toxic solvents, including chlorinated ones. In this article we present three case studies demonstrating alternative methods to achieve greater sustainability and/or reduce both environmental impact and operational cost. These methods include aqueous/non-aqueous reversed-phase chromatography (NARP) as well as super critical fluid chromatography (SFC).

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The power of patient engagement

80% of clinical trials are delayed due to recruitment problems. This is a well-known figure but despite its familiarity, it shouldn’t be normalised. It’s a dissatisfying number that calls for action to improve our work in clinical trials. Luckily, there’s a solution to this problem, and the even better news is that it will probably fix more than just the 80% issue. The aim of this article is to give a better understanding and overview of the challenges related to patient participation in clinical trials and providing actionable suggestions to activities that would solve these challenges and hopefully improve the drug development process all together.

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Personalised medicine – utopian future or a new healthcare norm?

Universalised healthcare may soon be outdated as advancements in genomics, bioinformatics, and related fields are changing the face of medicine. Moving from a one-size-fits-all approach to personalised care offers major benefits, like better treatment effectiveness and cost savings by tailoring interventions to individual genetic profiles. Although there are challenges, such as needing specialised infrastructure, funding, and navigating regulations, personalised medicine has the potential to improve preventive care, optimise treatments, and create a more efficient healthcare system.

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Collaboration key to delivering targeted medicines

Targeted medicines continue to make headway in the battle against chronic disease, changing the prognosis for many cancer patients, with the promise of breakthroughs in other fields. But the path to development and regulatory approval for these transformational products is complex, requiring a high degree of collaboration from the outset. This is particularly critical considering the urgent need of patients awaiting innovative treatments.
There are clear benefits in therapeutic and diagnostic teams working closely together during the development of targeted therapies. Similarly, sponsors that make the most of opportunities to engage with regulators as early as possible are better positioned to navigate the path to approval.

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