The ability to predict, probe and visualise the physicochemical structure of components within drug delivery systems and formulations has many applications throughout the lifecycle of a product, from supporting R&D to patent protection. 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.

Using advanced surface characterisation techniques to determine the construct of a formulation - what, where and how much � for successful delivery

246th National Meeting (2013)

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