Process for Encapsulating Soluble Biologics, Therapeutics, and Imaging Agents
Princeton Docket # 14-3045
The encapsulation and controlled release of peptides and bio-active materials is a significant challenge in the nanoparticle field. Researchers in the Department of Chemical and Biological Engineering at Princeton University have developed a novel "inverse" precipitation route to precipitate aqueous soluble species in a hydrophobic solvent, to crosslink the shell layer, and then to precipitate that construct into an aqueous medial to deposit a PEG biocompatible layer on the final construct. This approach to peptide, protein and soluble therapeutic agents enables controlled release of these compounds in biologic applications, and enables formation of biodegradable and erodible matrix phases with high loadings of these nanoparticles.
· Nanoparticles for the controlled release of biologics Background
· Enables formation of biodegradable and erodible matrix phases with high loadings of the novel nanoparticles
The delivery of biologics, including peptides, proteins, DNA, and RNA, is a growing area of interest in the pharmaceutical industry. Encapsulation and controlled release of biologics has been a significant obstacle to the advance of therapeutics since direct administration of the biologic results in rapid enzymatic attack and RES clearance. The new Princeton technology has demonstrated the encapsulation of biologics with 50% biologic loading in 60 nm nanoparticles and 75% loading in 230 nm nanoparticles. The encapsulation process results in essentially 100% encapsulation efficiency. This is in contrast with the conventional mode of encapsulation of biologics which involves using water/oil/water emulsion formation of particles using bioerodible polymers, such as polylactic acid or poly lactic-co-glycolic acid. These encapsulation processes produce formulations, where only 1-8% loadings are achieved and encapsulation efficiencies are usually less than 50%.
The Princeton technology is based on the rapid precipitation process that has been developed for the encapsulation of hydrophobic drug entities. It is scaleable and has been demonstrated for therapeutic and imaging agents. The new encapsulation process for biologics requires no covalent modification of the biologic and can be accomplished with biocompatible components. The final nanoparticle construct can be constructed with a biocompaticle PEG coating with enable long circulation and can be targeted by attachment of targeting ligands to the PEG chains.
Robert K Prud’homme is Professor of Chemical and Biological Engineering, Department of Chemical and Biological Engineering and the former of Director, Program in Engineering Biology, at Princeton University. His research focuses on how weak forces at the molecular level determine macroscopic properties at larger length scales. Equal time is spent on understanding the details of molecular-level interactions using NMR, neutron scattering, x-ray scattering, or electron microscopy and making measurements of bulk properties such as rheology, diffusion of proteins in gels, drop sizes of sprays, or pressure drop measurements in porous media. A major focus of his lab’s research is on using self-assembly to construct nanoparticles for drug delivery and imaging. The work is highly interdisciplinary; many of the projects involve joint advisors and collaborations with researchers at NIH, Argonne National Labs, CNRS in France, or major corporate research.
Robert Pagels is a graduate student in the Department of Chemical and Biological Engineering at Princeton University. He is an NSF Fellow and graduated from the University of Delaware.
Intellectual Property Status
Patent protection is pending.
Princeton is seeking to identify appropriate partners for the further development and commercialization of this technology.
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