An RNA encapsulation facility in your hand

The Micropore AXF (Advanced Cross Flow) range is expected to make a significant contribution to improving the performance of entire nanoparticle manufacturing processes through seamless scalability from initial R&D (0.2ml) to final pandemic-scale GMP manufacturing (1500L/hr).

The AXF-Pathfinder™ is a compact benchtop unit for Discovery, Development, Preclinical & 21 CFR Part 11 development of RNA/LNP therapeutics and vaccines. The Pathfinder rapidly generates formulation development samples into a standard multi-well plate for more efficient clinical development for new more easily scalable nucleic acid therapies.

Currently, most liposome drugs are produced by lipid hydration and extrusion, but this method suffers from multiple harsh processing steps which can compromise stability and give high batch variability. Impingement jet mixing (IJM) is most widespread but involves high turbulence mixing which can disrupt LNP stability. Microfluidic mixing offers rapid formulation with low polydispersity but again cannot accommodate high volume production.

The Micropore AXF range can overcome these roadblocks and offers scalability through a single device small enough to fit into the palm of your hand. Constructed of 316L stainless steel, the membranes have an indefinite lifespan — making it possible to achieve large scale production without the need to continuously buy consumables at exorbitant prices of hundreds of thousands of dollars just to run a single batch.

The Micropore AXF series is the next step in the evolution of LNP production.

The validation of mRNA vaccines has changed global views of non-traditional drug modalities, spurring interest for innovations in nucleic acid therapies and different drug delivery strategies. To better accommodate future pharmaceutical manufacturing, whether it be for novel drugs with unique production processes or global disease outbreaks, we will need to adopt more rapid, flexible, controlled, and efficient technologies. Micropore is currently working with multiple pharmaceutical companies globally to produce a fully integrated end-to-end process for continuous vaccine manufacture. Although IJM is currently the encapsulation method of choice for mRNA vaccine manufacturers, the economic and environmental potential for advanced crossflow in gene therapies, RNA/DNA vaccines, protein-based drugs, and other biologics cannot be overlooked¹.

Independently trialled by the University of Strathclyde, Professor Yvonne Perrie stated there was “No mRNA degradation in LNP production using AXF™ advanced crossflow mixing”, additionally this study found the LNP’s produced had mRNA Encapsulation Efficiencies beyond 97%.

At a local level, a LNP was produced using the AXF-Mini — result as pictured. Challenging this, the UNSW RNA Institute successfully replicated the experiment.

For further information, please contact Pete Davis, ATA Scientific: pdavis@atascientific.com.au, 0417 778 971

_{1. Fast, Controlled, and Consistent: An Exploration of Current mRNA Vaccine Production Technologies, Huen J, https://www.selectscience.net/application-articles/fast-controlled-and-consistent-an-exploration-of-current-mrna-vaccine?artID=57809}