Munich, Germany-based leon-nanodrugs (LEON) reports that it has completed development of its reactor for lipid nanoparticle production. Christian Nafe, CFO of LEON, says “this is a technological breakthrough” for production of LNPs, as well as for aseptic GMP-compliant encapsulation of transfection material (such as mRNA) or active pharmaceutical ingredients (APIs), at “any stage” of preclinical and clinical development up to market supply.
“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,” continues Nafe. “Our reactor is manufactured by Harro Höfliger [for delivery] 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
“The modular system has interchangeable nozzles with a diameter between 100 µm and 500 µm with a deviation of only 2 µm.” notes Frank Stieneker, PhD, chief scientific officer. “Consequently, we can measure excellent data in terms of particle size reproducibility and distribution.”