Innovative FR-JET Technology
leon-nanodrugs GmbH (“LEON”), a developer of cutting-edge nano technology devices for the pharmaceutical industry, has been active in the nanotechnology space since 2011. LEON is specializing in the development and commercialisation of devices for the encapsulation of genetic material and other active substances into nanodrug carriers, such as lipid nanoparticles (LNPs).
The Munich-based company engineers its innovative manufacturing equipment based on its proprietary flexible reactor jet technology (FR-JET Technology), empowering pharma companies and small biotech as well as CDMOs to streamline development and manufacturing of nanomedicines and to take full advantage of the significant progress being made in advanced therapies.
The innovative FR-JET technology enhances the principles of jet impingement significantly and transforms into an effective solution for bottom-up synthesis of nanoparticles. Its unique reactor geometry offers several process control handles, to generate high integrity nanoparticles with desired particle characteristics. The technology is applicable to a broad range of particle types: lipid-based, polymeric, and inorganic particles.
New possibilities
Nanoparticle medicines are of paramount importance for healthcare applications. Nanoparticles allow for increasing bioavailability of drugs and for specific delivery of active substances to their target site. With the new technology platform developed by Leon Nanodrugs, nanoparticles for healthcare can be developed and produced much faster, easier and more economically. The scale up process is seamless and does not require an intermediate pilot equipment, accelerating process development and reducing validation times by several orders of magnitude.
In cooperation with Harro Höfliger, the assembly of the fully-automated aseptic device, NANOus®, for the GMP-compliant nano-encapsulation of APIs on a commercial scale is under way.
It features cleaning-in-place (CIP) and sterilization-in-place (SIP) options and integrated process monitoring components that enable real-time testing of critical process parameters (CPP) and selected critical quality attributes (CQAs). Its closed design minimizes risk of contamination during aseptic manufacturing.
“Our FR-JET Technology is the beating heart of our NANO devices”
Dr. Setu Kasera
CSO at LEON
"Scale up with conventional manufacturing devices from R&D to GMP can often go wrong, carrying risks of very expensive batch failures, having to go back to development or failing completely. These risks are negligible with our devices because they use the same reactor core from the lab to commercial scales."
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Clean solutions for dosing liquids and for sterile filling, packaging and assembly