Polymeric Nanoparticle Compositions for Encapsulation and Sustained Release of Protein Therapeutics and Methods for Scalable Production of the Same

Unmet Need
Protein therapeutics are used for a variety of medical treatments, such as cancer, infectious disease, hemophilia, anima, etc. The global market for protein drugs reached $174.7 billion in 2015. Therapeutic proteins support targeted therapeutic processes by compensating the deficiency of an essential protein. To successfully administer protein therapeutics, the delivery system must consist of biodegradability, a high loading capacity, controlled/sustained long-term releases, and scalable production. Many therapeutic proteins have short biological half-lives and are difficult to deliver to the target site. Two types of delivery systems, hydrogel and nano/micro particles prepared by poly(lactic-co-glycolic acid) (PLGA), are often used, however they do not offer sustained long-term release or controlled release concentration, respectively. Thus, there is a need for sustained release of protein therapeutics through a scalable and reproducible method.
 
Technology Overview
Inventors at Johns Hopkins have a developed a continuous and scalable method to prepare biodegradable nanoparticles with core-shell structures, and high payload capacity for the delivery of protein/antibody therapeutics. The invention describes the preparation of nanoparticles with encapsulated polyelectrolyte complexes (PEC) of proteins/antibodies and counter ion polymers. By complexing protein therapeutics into PEC nanoparticles with polyelectrolytes carrying the opposite charge, the resultant PEC nanoparticles are coated to form core-shell nanoparticles. These core-shell nanoparticles enable a sustained and prolonged release of proteins. The release rate can be adjusted by manipulating the weight ratio of protein to polymer or choosing different di-block copolymers. This technology allows spatiotemporally-controlled release of nanoparticles for various protein therapeutics, including antibody pharmaceutics. Using these techniques, protein delivery nanoparticle devices can improve delivery efficiency and pharmaceutical properties
 
 
Stage of Development
The inventors have tested this method with nanoparticles NP9, NP9, NP10 and NP11, and determined the zeta potentials and encapsulation of efficiencies. The results indicate that the release profile of the system could be modified through different degradation rates and polymers.
 
 
Publications
Santo JL. Small 12(45): 6214-6222, 2016.
 

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