Modelling approaches for bio-manufacturing operations.

Fast and cost-effective methods are needed to reduce the time and money needed for drug commercialisation and to determine the risks involved in adopting specific manufacturing strategies. Simulations offer one such approach for exploring design spaces before significant process development is carried out and can be used from the very earliest development stages through to scale-up and optimisation of operating conditions and resource deployment patterns both before and after plant start-up. The advantages this brings in terms of financial savings can be considerable, but to achieve these requires a full appreciation of the complexities of processes and how best to represent them mathematically within the context of in silico software. This chapter provides a summary of some of the work that has been carried out in the areas of mathematical modelling and discrete event simulations for production, recovery and purification operations when designing bio-pharmaceutical processes, looking at both financial and technical modelling.

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