Production Cost Analysis

Production Cost Analysis Economic Analysis as a tool for impact 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 humanity therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. 1,2This 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. belatedly performed an economic comparison of conventional versus disposables-based technology for the production of an antibody fragment from anE. colifermentation. 7The authors concluded that the capital investment required for a disposables-based option is substantially reduced slight 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 overbearing 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 lotion 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, enlightenment filtration, and microfiltration are commonly apply. In a recent publication, different harvest approaches were investigated for a case study involving recovery of a therapeutic protein fromPichia pastorisfermentation broth. 10 pic Figure 1. Schematics for options 1 and 2 that are examined in this economic analysis This article, the sevent h 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. BACKGROUND pic Table 1. Comparison of process performance for option 1 and option 2. able from reference 10. Figure 1 illustrates the two options that will be examined in this economic analysis.Option 1 involves a three-unit operation harvest process centrifugation, followed by reasonableness filtration, and completed with a tightness and buffer exchange via tangential flow ultrafiltrationdiafiltration (UFDF). Option 2 involves a two-unit operation process microfiltration followed by a concentration and buffer exchange via tangential flow filtration (UFDF). Table 1 presents a comparison of process performance under the two options. Under optimal conditions, both(prenominal) options can deliver the desired product recovery ( 80%), harvest time (