Protein Nanoparticles

摘要

Protein nanoparticles can be utilized for the pulmonary delivery of protein therapeutics or can be incorporated into biodegradable polymer microspheresanospheres for controlled release depot or oral delivery. With proteinaceous therapeutics, the generation of nanoparticles is particularly problematic. Existing practices have difficulty achieving the desired particle size distribution, expose the protein to denaturing conditions such as heat, organic solvents or air and often require stabilizing excipients or leave residual product contamination that necessitates further processing. Our process utilizes supercritical, critical or near-critical fluids with or without polar entrainers (SuperFluids ™) to penetrate the protein aggregates and then utilizes the expansive energy of SuperFluids™ to disaggregate protein crystals into monodisperse nanoparticles.