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
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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.7 The 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
Quick Recap
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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
Figure 1. Schematics for options 1 and 2 that are examined in this economic analysis
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This article, the seventh in the "Elements of Biopharmaceutical Production" series, describes how economic analysis can be
used to compare different processes and assist in designing an "economical" option.
