With increasing pressures to meet the tight financial constraints and to win the competition in the biopharmaceutical market, companies are facing the challenges for the fast realisation of cost effective and high yielding processes. This presentation describes a decisional tool that integrates a process economics model with uncertainty analysis and optimisation algorithms for the evaluation of alternative downstream processing strategies, considering the trade-offs between process operation and cost of goods (COGs). Case studies are used to illustrate the application of the decisional tool in evaluating alternative downstream process flowsheet utilising newer chromatography resins and novel separation techniques such as mixed-mode chromatography, precipitation, etc, to assist decision-making during process development in selecting the most efficient and cost-effective processes. Alternative manufacturing strategies for both single and multi-product manufacturing scenarios have also been investigated considering a range of products with various titre and product demands.Key words:  Decisional tool, process economic analysis, alternative bioseparation techniques, multi-product facility, capacity utilisation.

Decisional tool in supporting cost-effective bioprocess development

243rd National Meeting (2012)

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