LEON successfully completes development of its innovative reactor for more efficient production of lipid nanoparticles
Seamless scalability via the flexible reactor facilitates significant time savings throughout development stage up to market supply

• LEON achieved superior accuracy in development of its proprietary reactor, facilitating exceptional inter-device reproducibility of particle size and distribution, and thus seamless process transfer, from development stage to commercial scale
• The prerequisites to manufacture the LEON reactor in series are therefore met – a milestone achievement on the road to broad application of the NANOnow product platform for the encapsulation of APIs such as mRNA in lipid nanoparticles
• LEON management available for meetings in San Francisco during JP Morgan Week (January
  9-12, 2023)

January 3, 2023 – Munich (Germany) – leon-nanodrugs GmbH (“LEON”), a disrupting enabler of nanotechnology for the pharmaceutical industry, today announces the successful completion of its reactor development. With all prerequisites set for serial production, the proprietary reactor will now provide excellent inter-device reproducibility of nanoparticle features. This is a technological breakthrough for production of LNPs, as well as for encapsulation of transfection material (such as mRNA) or active pharmaceutical ingredients (APIs), at any stage of preclinical and clinical development up to market supply.

Christian Nafe, CFO of LEON, commented: “The results of our reactor studies strongly support that LEON has reached an important milestone in product development and is well on its way towards commercialization. Our reactor is manufactured by Harro Höfliger with highest precision. This enables us to deliver on our promise of seamless process transfer - from preclinical scale for product and process development up to market supply. The implementation of the reactor in all devices of our NANOnow platform puts us on the right track to bring our solution for a significantly faster and more efficient production of LNPs and other gene transfer products to the market and to meet the requirements of the biopharmaceutical industry.”

“Our proprietary reactor can now be manufactured with high precision, leading to an exceptionally low variability. The modular system has interchangeable nozzles with a diameter between 100 µm and 500 µm with a deviation of only 2 µm. Consequently, we can measure excellent data in terms of particle size reproducibility and distribution,” added Dr. Frank Stieneker, CSO of LEON. “These great results would not have been possible without the dedicated and passionate work of our research team, for which I am truly thankful.”

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ABOUT LEON-NANODRUGS

leon-nanodrugs’ (“LEON”) aim is to create a new norm for the production of nanoparticle-based therapeutics by establishing their technology for seamless scale-up and high-performance output. The Munich-based private company was founded in 2011 and since then has successfully pursued its mission of enabling the biotechnology and pharmaceutical industry, as well as Contract Development and Manufacturing Organizations (CDMOs), with a disruptive manufacturing technology to encapsulate mRNAs or active pharmaceutical ingredients (APIs) into lipid nanoparticles (LNPs). The increase in efficiency and speed will broaden access to mRNA vaccines, therapeutically enhanced biologics or small molecules, and improve economic feasibility for the benefit of patients and healthcare systems. LEON’s intellectual property is broadly protected with international coverage through 2041.

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