A research team based in the Netherlands has developed a compact, microfluidic device that could allow hospital pharmacies to formulate personalized RNA medicines on-site. Their study outlines the design and testing of the NANOSPRESSO platform, a point-of-care platform that automates the mixing and production of sterile RNA-loaded lipid nanoparticles for injectable use.
NANOSPRESSO uses single-use cartridges pre-loaded with lipids and aqueous RNA solutions. These are combined within a microfluidic mixer – similar in concept to a capsule coffee machine – to create LNPs. The device includes sterile downstream processing to meet regulatory requirements, including sterile filtration, dilution, and aseptic vial filling. It is designed to be operated by pharmacy staff with minimal training. Theoretically, it can also be adapted for a variety of RNA payloads, including mRNA and antisense oligonucleotides.
According to the authors, “Despite their potential, nucleic acid therapeutics have encountered formidable barriers to their development and accessibility, rooted in economic and pharmaceutical constraints. High costs, complex manufacturing processes, and stringent regulatory requirements have historically impeded the progress of nucleic acid-based treatments, particularly for orphan diseases affecting small patient populations.”
Their hope is that the NANOSPRESSO system can “redefine the reach and impact of nanomedicine.” Rare diseases are collectively common, affecting millions of people worldwide. However, their individual rarity often puts them outside the scope of conventional drug development pipelines.
In experimental tests, the team successfully produced RNA-LNP formulations with particle sizes of approximately 80–100 nm and high encapsulation efficiency. The LNPs retained functional mRNA activity when tested in vitro.
The authors concluded, “NANOSPRESSO’s innovative approach transforms the landscape of nano-enabled ATMPs. By tackling the regulatory challenges intrinsic to such a pioneering paradigm, it paves the way for regulatory frameworks that embrace the intricacies of nanomedicine and personalized care.”
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