Economic comparison between conventional and disposables-based technology for the production of biopharmaceuticals

Time to market, cost effectiveness, and flexibility are key issues in today 's biopharmaceutical market. Bioprocessing plants based on fully disposable , presterilized, and prevalidated components appear as an attractive altern ative to conventional stainless steel plants, potentially allowing for shor ter implementation times, smaller initial investments, and increased flexib ility. To evaluate the economic case of such an alternative it was necessary to de velop an appropriate costing model which allows an economic comparison betw een conventional and disposables-based engineering to be made. The producti on of an antibody fragment from an E. coli fermentation was used to provide a case study for both routes. The conventional bioprocessing option was co sted through available models, which were then modified to account for the intrinsic differences observed in a disposables-based option. The outcome o f the analysis indicates that the capital investment required for a disposa bles-based option is substantially reduced at less than 60% of that for a c onventional option. The disposables-based running costs were evaluated as b eing 70% higher than those of the conventional equivalent. Despite this hig her value, the net present value (NPV) of the disposables-based plant is po sitive and within 25% of that for the conventional plant. Sensitivity analysis performed on key variables indicated the robustness of the economic analysis presented. In particular a 9-month reduction in time to market arising from the adoption of a disposables-based approach, resul ts in a NPV which is identical to that of the conventional option. Finally, the effect of any possible loss in yield resulting from the use of disposa bles was also examined. This had only a limited impact on the NPV. for exam ple, a 50% lower yield in the disposable chromatography step results in a 1 0% reduction of the disposable NPV. The results provide the necessary frame work for the economic comparison of disposables and conventional bioprocess ing technologies. (C) 2001 John Wiley & Sons, Inc.