Biogel Technology has been active in developing methods to modify the surface of biodegradable microparticles and nanoparticles since 1993. These nanoparticles, based on poly (lactic-co-glycolic acid) (PLAGA) can be used to target drug delivery to specific cell types in vivo. While many techniques have been developed for larger scale production on PLAGA microparticles, the preparation of submicron PLAGA particles containing an active agent poses serious challenges that are not necessarily present when preparing larger diameter microparticles. No commercial-scale processes currently exist for preparation of biodegradable nanoparticles. The scientific literature contains references to a number of preparation techniques, but almost all are on a very small laboratory scale. This Phase I NSF SBIR Proposal describes our research plan for scaling up nanoparticle preparation techniques. We plan to expand our current processing techniques, which yield approximately 100 mg per batch, to a process that will yield 100 g of nanoparticles per batch. These targeted delivery formulations are being studied for treatment of various types of cancers, as well as, acute blood clots. Potential Commercial Applications of the Research If successful, this technology will form the basis for commercial production of biodegradable nanoparticles. No such techniques currently exist and are necessary before products using targeted nanoparticles may be produced. The results of this project will form the scientific and commercial basis to further develop a wide range of products, including those to treat cancer and acute blood clots. Key Words to Identify Research or Technology: biodegradable, nanoparticles, processing, scale-up
