Micropore AXF range for nanoparticle engineering

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The Micropore Advanced crossflow (AXF) system is a pioneering technology with the potential to transform nanoparticle production and democratise medicine. Constructed of 316L stainless steel, it requires no single-use consumables and therefore avoids the problem of leachables common with other devices. Operating at low pressure, Micropore AXF systems are designed to enable precise control over particle size and uniformity across a diverse range of formulations.

Independent research at the University of Strathclyde, led by Dr Yvonne Perrie, has demonstrated that Micropore’s AXF devices deliver no detectable degradation to mRNA, which is widely acknowledged to be very sensitive to energy inputs and particularly so for the larger oligonucleotides like saRNA. The group has noted mRNA encapsulation efficiencies nearing 100% in liquid nanoparticle (LNP) production using the AXF technology, indicating that it can provide efficient mass production of LNP-based therapeutics.

The power of the system lies in its ability to seamlessly scale from microlitres to litres without the need for consumables or cumbersome modifications. From the AXF-Mini to the Horizon m, a fully CFR 21 Part 11 compliant GMP production system is capable of production volumes of 0.5–2000 L/h, custom built to client specification for capacity, feed system (pumped or pressure), full DQ/IQ/OQ/PQ support and PLC integration — and this is just the smallest version. The AXF-1 has a total flow rate of 2000 mL/min; by extending the AXF-1 to an AXF-4, the technology begins to approach pandemic readiness.

Micropore Technologies is now working on resolving a major bottleneck in the production of nanomedicines: the tangential flow filtration (TFF) step that can take many hours to complete and is detrimental to the particles, reducing encapsulation efficiency considerably and costing millions of dollars in payload and time. While not yet developed fully, the AXF system could be used in the future for single-pass TFF.

For more information: https://www.atascientific.com.au/products/axf-pathfinder/.