Authors: R.R. Hood, E.L. Kendall, W.N. Vreeland, M. Junqueira, J.C. Finkel, D.L. DeVoe
Affilation: University of Maryland, United States
Pages: 194 - 197
Sophisticated analytical technologies are available enabling the direct correlation of physicochemical structure to overall function and formulation attributes through generation of spatially resolved information. This presentation will cover two case studies where advanced, surface sensitive techniques have been used as part of biopharmaceutical development for a recombinant HIV vaccine and a gene therapy formulation. As part of this review, some of the key surface analytical technologies will be briefly introduced. The presentation will focus on how the understanding of the physical nano- and microstructure of biopharmaceutical formulation can yield insight into the link between processing and both physicochemical and biological properties. This will include determination of the coverage and mechanism of loading of antigens and control proteins onto microparticle colloidal delivery systems generated using different formulation designs. The talk will also cover the assessment of stability of prototype, non-viral, polymer gene delivery vectors against enzymatic degradation and impact on ultimate gene delivery success.