Production Cost Analysis

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Production Cost Analysis: Economic Analysis as a tool for Process Development: Harvest of a High Cell-Density Fermentation

For the biotech industry to be profitable, it must consider economics along with process recovery, purity, and product quality.

The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased.1,2 This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.3-6 |[pic] |

Novais et al. recently performed an economic comparison of conventional versus disposables-based technology for the production of an antibody fragment from an E. coli fermentation.7The authors concluded that the capital investment required for a disposables-based option is substantially reduced—less than 60% of that for a conventional option. The disposables-based running costs were 70% higher than those of the conventional equivalent. However, the net present value of the disposables-based plant was found to be positive and within 25% of that for the conventional plant. More recently, the economic feasibility of using disposables has been examined for facility design, highlighting the need to perform a thorough analysis for the application at hand.8,9 |[pic] |

|Quick Recap |

Harvesting biotechnology products from cell culture or fermentation process streams is often performed by a combination of several-unit operations. Centrifugation, depth filtration, and microfiltration are commonly used. In a recent publication, different harvest approaches were investigated for a case study involving recovery of a therapeutic protein from Pichia pastoris fermentation broth.10 |[pic]...
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