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.
Nov 01, 2006

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



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
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
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.