leon-nanodrugs GmbH (LEON), a provider of nanotechnology for the pharmaceutical industry, has completed its reactor development. With all prerequisites set for serial production, the proprietary reactor will now provide 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.

“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,” said Christian Nafe, chief financial officer, LEON. “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.”

Frank Stieneker, chief science officer, LEON, said, “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. These great results would not have been possible without the dedicated and passionate work of our research team, for which I am truly thankful.”