Abstract: A scalable method for producing DNA/polycation particles having an optimal, defined particle size with multiple virus assembly plasmids for efficient transfection of viral production cells in suspension cultures. The presently disclosed DNA/polycation particles yield superior and reproducible transfection activity and shelf stability in the suspension form and can be used as an off-the-shelf product. The presently disclosed DNA/polycation particle formulation can potentially simplify and streamline the viral manufacturing process and improve production quality and consistency.

Abstract: Methods for preparing nucleic acid/lipid particles of an optimum particle size for efficient transfection of cells in vitro and in vivo local transfection are provided. The method is based on kinetic control of the nucleic acid/lipid nanoparticle assembly to prepare shelf-stable particles with defined sizes between about 50 nm and 1200 nm. The size-dependent characteristics of the nucleic acid/lipid particle-mediated transfection for the size range between 50 nm and 1200 nm also is provided.

Abstract: Disclosed are the optimal composition and size of DNA/polycation particles for efficient transfection of viral production cells in both adherent and suspension cultures. The size-dependent feature of DNA/polycation particle-mediated transfection for particles between 50 nm and 1000 nm also is disclosed. A new scalable method based on kinetic control of DNA/polycation nanoparticle assembly to prepare shelf-stable particles with defined sizes between 50 nm and 1000 nm also is disclosed. The presently disclosed DNA/polycation particles yield superior and reproducible transfection activity and shelf stability and can be used as an off-the-shelf product.

Abstract: A process and a device for continuous micromixing of two fluids is disclosed. The process and the device can be used in particular when micromixing plays an important role, for example, in the yield and characteristics of the products. This is the case for crystallization, precipitation and combustion reactions and for micelle assembly or polyelectrolyte complexation processes.

Abstract: The presently disclosed subject matter provides a kinetically controlled mixing process, referred to herein as “flash nanocomplexation” or “(FNC),” to accelerate the mixing of a polyanion solution, for example, a plasmid DNA solution, with a polycation solution to match the polyelectrolyte complex (PEC) assembly kinetics through turbulent mixing in a microchamber, thus achieving explicit control of the kinetic conditions for nanoparticle assembly as demonstrated by the tunability of nanoparticle size, composition, hydrodynamic size, hydrodynamic density, surface charge, and polyanion payload.

Abstract: Nanoparticle are described comprising a tannic acid, a trivalent metal ion, and a pharmaceutical agent comprising a water-soluble biologically active agent, such as a protein, a water-soluble peptide, small molecule or a combination thereof and methods of making and using the nanoparticles. Some nanoparticles of the present invention include 30-60% (w/w) of a tannic acid, 0.1-20% (w/w) of a trivalent metal ion, and 1-50% (w/w) of a pharmaceutical agent.