By Aphios Corp.
Protein Nanoparticles (PNP) technology platform utilizes the expansive energy of supercritical fluids with or without polar cosolvents (SuperFluids™ [SFS]) to disaggregate or comminute protein crystals and amorphous powders into monodisperse nanoparticles [US Patent]. The PNP process uses SuperFluids™ to form small protein particles without first dissolving the material in a liquid solvent. As such, the target therapeutic retains full activity and is devoid of residual processing chemicals such as solvents, salts or surfactants. The energy necessary for the size reduction is derived from a rapid depressurization of the SuperFluids™. The low temperature generated by the expansion of the supercritical fluid helps to preserve the chemical integrity of the protein and is an advantage over conventional grinding processes that generate heat. Benefits/Advantages of the PNP Process: - Forms monodisperse protein particles [0.5 to 5 micron (μm)] without having to first dissolve the protein in a liquid solvent - Robust for a wide range of enzymes & sizes - High retention with possible enhancement of bioactivity - Not constrained by limited solubility in benign solvents such as ethanol that may be used with other supercritical fluid techniques, and the utilization of large volumes of liquids that limits other techniques such as spray drying - Produces a Joule-Thompson cooling effect, and thus avoids heat associated with milling techniques that can cause protein degradation and contamination by metal particles - Improves processes and products in the area of drug delivery, e.g., more uniform and extended-release of therapeutic from microsphere carriers or more uniform aerosol formulations - Improves product quality with no residual solvent or surfactant contamination - Environmental advantages due to the elimination of the use of organic solvents. - Physical, single step, a single-pass process that is scalable - Improves process economics due to simplification of the process train Applications of the PNP Process: Aphios’ protein nanoparticles (PNP) process can be used for oral/subcutaneous/pulmonary delivery of hydrophobic drugs such as paclitaxel, camptothecin, and betulinic acid, proteins such as insulin, calcitonin and human growth hormone, peptides, genes and vaccine antigens for anthrax, HIV and influenza. Partnering Opportunity: Contact us if you are interested in conducting a feasibility study and/or establishing a research and development partnership.