| Summary: | Biopharmaceutical forms a new class of medicine which is biologically active and produced by recombinant technology or obtained from living organisms. It can be diversified into a range of subtype of drugs such as therapeutic enzymes, monoclonal antibodies, subunit proteins, nucleic acid and genetic materials. They have been used extensively for clinical application involving disease treatments, prevention and diagnosis. Unlike small molecule compounds, their chemical structures are more complex and can crucially influence their activity. However, these highly ordered conformation are often transformed upon exposure to physical stress during manufacturing such as extreme temperature, pH and high shear. This posses a challenge for the development of biologics and highlights the need of a more friendly formulation technique for macromolecules. Electrohydrodynamic atomisation (EHDA) is a process where using electrical energy to break up a bulk liquid into fine jets. The process allows the fabrication of micro to nano-scaled structures including particles or fibres without using heat involved. This can avoid the thermally induced degradation emerged during the formulation of macromolecules. Additionally, numerous materials can be fabricated by EDHA such as polymers, hydrogels and ceramic, thus enabling the design of various drug delivery systems. The aim of this PhD project is to undertake a conceptual study using EHDA to formulate biopharmaceuticals. Four biologics, alkaline phosphatase (ALP), bevacizumab (Avastin®; a whole-length monoclonal antibody used for neovascularization treatment), poly(inosinic-cytidylic acid) (poly-IC; an immunopotentiator), and ovalbumin (a model vaccine antigen) were processed into composites with polymers including poly(vinylpyrollidone) (PVP), poly(ε- caprolactone) (PCL) and poly(lactide-co-glycolide) (PLGA). Micron-nano sized fibres and particles for implantable biologic formulations were produced. Material properties and the activity of the developed formulation were characterised to identify the best formulation for biopharmaceutics.
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