Lin, B.; (2008) Evaluation of advanced wound healing products from an operational and financial perspective. Doctoral thesis , University of London.

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Abstract

A shift in the global chronic wound care market from traditional wound dressings to advanced bio-derived products has demonstrated the demand for the 1st generation of skin substitute products. Although these demonstrated the proof-of-concept for tissue engineering, the manufacturing processes were mainly laboratory based, labour intensive and not amenable to scale-up. The aim of this thesis was to carry out a technical and economical evaluation of alternative manufacturing options for the next generation of cell-derived wound healing products delivered in an amorphous gel format. Experimental work was carried out to demonstrate the feasibility of an alternative manufacturing process culturing human dermal fibroblasts (HuFFs) to generate extracellular matrix. A microcarrier-based process was selected and results showed the HuFFs proliferated well on both Cytodex 2 and biodegradeable Vicryl discs. Limitations with both approaches are discussed. Economic feasibility of the microcarrier based processes was evaluated, and this was compared to the conventional manual and automated roller bottle processing route. Impact of manufacturing options on the cost of goods and net present value were assessed. Deterministic analysis indicated that the key process economic drivers are the cell density and the ratio of cells to extracellular matrix. Additionally, stochastic analysis was applied to rank each process options in terms of risk-reward characteristics and this showed sensitivity to the production capacity required. Further process economics analysis evaluated the feasibility behind recombinant growth factor production using both E.coli and yeast processing routes, and the analysis highlighted critical titre levels required for this option to be feasible. The work in this thesis demonstrates the use of simulation tools and risk analysis to support the quality of decision making to enable a cost effective manufacture of advanced wound healing products.

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