Re-design of Downstream Processing Techniques for Nanoparticulate Bioproducts

Abstract

There has been much interest generated in the recovery of nanoparticulate (nanoparticle) bioproducts<br />(Second generation of biotechnological products) such as plasmid DNA and viruses as putative gene therapy<br />vectors, macromolecular assemblies as drug delivery vehicles and virus-like particles as vaccine components.<br />Such product must be manufactured in advanced stages of purity, material definition and sophisticated formulation to rival those demanded of the pharmaceutical macromolecules which dominate as the first generation products. Nanoparticulates are characterized by a critical size range (10-300 nm diameter) and complexity of surface chemistry and internal organisation which pose new challenges in separation science and engineering, controlled chemistries of modification and material measurement not readily addressed by extant technologies. Current review article is concerns with structural characterisations of nanoparticulate bioproducts as well as redesign of their downstream processing techniques which are common to all programmes. This focus is upon candidate partition systems which can contribute to the fractionation, recovery and purification of nanoparticulate assemblies from their soluble components (capsid proteins from virus, polynucleotides from plasmid DNA, soluble, agglomerated forms of protein etc.). The mechanistic design of new separation and formulation technologies based upon a sound understanding of quantifiable structural features of these nanoparticle bioproducts is strongly indicated.<br /><br />