Economic analysis of royalactin production under uncertainty: Evaluating the effect of parameter optimization

Abstract

Royalactin is a protein with several different potential uses in humans. Research, in insects and in mammalian cells, has shown that it can accelerate cell division and prevent apoptosis. The method of action is through the use of the epidermal growth factor receptor, which is present in humans. Potential use in humans could be to lower cholesterolemic levels in blood, and to elicit similar effects to those seen in bees, e.g., increased lifespan. Mass production of Royalactin has not been accomplished, though a recent article presented a Pichia pastoris fermentation and recovery by aqueous two‐phase systems at laboratory scale as a possible basis for production. Economic modelling is a useful tool with which compare possible outcomes for the production of such a molecule and in particular, to locate areas where additional research is needed and optimization may be required. This study uses the BioSolve software to perform an economic analysis on the scale‐up of the putative process for Royalactin. The key parameters affecting the cost of production were located via a sensitivity analysis and then evaluated by Monte Carlo analysis. Results show that if titer is not optimized the strategy to maintain a low cost of goods is process oriented. After optimization of this parameter the strategy changes to a product‐oriented and the target output becomes the critical parameter determining the cost of goods. This study serves to provide a framework for the evaluation of strategies for future production of Royalactin, by analyzing the factors that influence its cost of manufacture. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 31:744–749, 2015

Economic evaluation of the development of a phage therapy product for the control of Salmonella in poultry

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“…To enter labor economic database, Biosolve wages for production operator, production supervisor, quality control, and quality assurance were input into Biosolve, as it divides labor in these four major areas. Moreover, based on the literature, labor accounts, in average, for the 15% of the production cost, because of this, labor was adjusted to represent a 15% of the CoG. Labor was set fixed to the amount of workers Biosolve calculated, this means that during the calculations for all the different product scenarios, labor contribution changes accordingly.…”

Monte Carlo economic analysis of Baker's yeast invertase purification using two‐ and three‐phase partitioning

“…One of the major constraints of large‐scale ATPS is the processing to remove phase components, which are considered contaminants. It was previously demonstrated that UF/DF can hinder the potential use of an industrial‐sized ATPS because the high turnover of membrane filters required for this unit operation, which contributes to high production costs . This needs to be evaluated, but the present work analyzed the increase in sample input, therefore requiring a reduced system which could become insensitive to the costs of phase removal operations.…”

“…A previous study reports that the total volume of ATPS can hinder the recovery of proteins at an industrial scale, as once the protein is separated in one of the phases, the other components become contaminants that must be removed. This serves to increase the production costs, as the next unit operation must process a larger sample than that initially loaded into the system …”

“…Moreover, modeling techniques, like Monte Carlo simulation, can be incorporated to mimic real‐life variation and understand their impact on production costs. Examples of successful application of these tools include comparisons between different types of equipment or operating strategies, optimization of different operation parameters, evaluation of different purification strategies, analysis of different strategies for developing autologous cell therapies, and analysis of pilot‐scale production of protein‐based pigments …”