Biopharmaceutical development is often delayed in part by the extensive stability analysis and formulation refinement entailed in the early stages. Determination of a suitable therapeutic protein or peptide and the ideal formulation requires consideration of t he delivery route, dose and the stability of both the active ingredient and the formulation as a whole. The selection of appropriate buffering agents and other excipients is of utmost importance in this process, but can be time consuming due to their huge variety and the necessity for thorough testing of each component. Currently this testing is performed by a number of different techniques eit her to observe changes in protein structure or by detecting aggregation once it has occurred. Considering this, we identi› fied a need for an approach which, using a small amount of material, had the capability to detect the propensity for a given biopharmaceutical to be unstable and/or aggregate in a part icular set of formulation conditions. Such a technique could allow additional screening to be performed earlier in the drug development process, enabling the early identification and further refinement of drug candid ates and formulations. An atomic force microscopy force measurement based technique was proposed to meet t his need. This thesis details the first steps in developing an assay fit for this purpose.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:755823 |
| Date | January 2014 |
| Creators | Croad, Oliver William |
| Publisher | University of Nottingham |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
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