Plat­form for nanotechnology

Nanopar­ti­cles can sta­bi­lize vac­cines and phar­ma­ceu­ti­cals, increase the bioavail­ability of drugs and deliver sub­stances to their target site. With the new tech­nology plat­form devel­oped by leon-nan­odrugs, nanopar­ti­cles for health­care will be pro­duced faster, easier and more eco­nom­i­cally in the future.

When the first vac­cines against Covid-19 based on mRNA were approved for use, ­nan­otech­nology also came into the focus of the broader ­public. Naked mRNA degrades readily. There­fore, in order to sta­bi­lize mRNA and deliver it to the target cells to trigger an immune ­response suc­cess­fully, it was packed inside nano-sized trans­port cap­sules. These cap­sules, or “lipid nanopar­ti­cles” (LNP), act as a vehicle for genetic mate­rial or other active phar­ma­ceu­tical substances.

With LNPs, sub­stances can be tar­geted to spe­cific regions of the body, which is of great advan­tage in cancer therapy, among others. leon-nan­odrugs, a Munich-based start-up, has been active in the ­nan­otech­nology space since 2011, with a clear goal: to make the pro­duc­tion of ther­a­peu­tics based on nanopar­ti­cles easier, more effi­cient and more eco­nom­ical through fast and seam­less scale-up. To this end, leon-nan­odrugs has devel­oped the ­NANOnow tech­nology, with its pro­pri­etary jet impinging reactor, in which sub­stances col­lide at high speed. This patented plat­form is a break­through tech­nology designed for con­tin­uous, reli­able encap­su­la­tion of mRNA, bio­mol­e­cules or other active phar­ma­ceu­tical ingre­di­ents (API) into lipid nanopar­ti­cles with a repro­ducible size between 10 nanome­ters and up to 70 micrometers.

New Pos­si­bil­i­ties

NANOnow has long out­grown the lab­o­ra­tory envi­ron­ment. 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. This man­u­fac­turing device is par­tic­u­larly suited for flex­ible pro­duc­tion of LNP-based vac­cines, enabling encap­su­la­tion of active sub­stance for 6 to 8 mil­lion vac­cine doses per day. It fea­tures an inte­grated process analysis tech­nology (PAT) that enables real time product release.

“Staying true to our motto ‘One process, one reactor’, which per­fectly com­ple­ments Harro Höfliger‘s phi­los­ophy ‘From Lab to Pro­duc­tion’, NANOnow can be imple­mented in var­ious pro­duc­tion sys­tems. Scale-up takes place using the same reactor core and there­fore is much faster, since new val­i­da­tion of the process is not required,” says Dr. Setu Kasera, Head of Sci­ence and Engi­neering at leon-nan­odrugs. “This opens up new oppor­tu­ni­ties to make LNP-based med­i­cines widely avail­able for public health­care and tar­gets unmet needs of phar­ma­ceu­tical and biotech indus­tries, as well as con­tract man­u­fac­turers (CDMOs).”

Harro Höfliger is not only ­respon­sible for the devel­op­ment and pro­duc­tion of ­NANOus; their Pharma Ser­vices depart­ment also sup­ports leon-nan­odrugs in product devel­op­ment work. Fur­ther joint appli­ca­tions of nan­otech­nology are in the pipeline, for example for per­son­al­ized med­i­cine, another increas­ingly impor­tant future market.

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Photos: leon-nan­odrugs GmbH