Production Cost Analysis

Production Cost compend Economic Analysis as a tool for Process reading Harvest of a High Cell-Density Fermentation For the biotech industry to be profitable, it must(prenominal) consider economics along with process recovery, purity, and product quality. The number of biotechnology-based homophile therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, hold 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 atomic number 18 stinting, as well as optimal and robust. 3-6 pic Novais et al. recently performed an economic comparison of pompous versus disposables-based technology for the return of an antibody fragment from anE. coli hullabaloo. 7The authors concluded that the capital investment required for a disposables-based survival of the fittest is s ubstantially reducedless than 60% of that for a conventional option.The disposables-based racecourse costs were 70% higher than those of the conventional equivalent. However, the net present order 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 consume to perform a thorough analysis for the application at hand. 8,9 pic riotous Recap Harvesting biotechnology products from cell culture or fermentation process streams is often performed by a combination of several-unit carrying into actions. Centrifugation, depth filtration, and microfiltration are commonly used. In a recent publication, different increase 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 thi s 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. BACKGROUND pic Table 1. Comparison of process exercise for option 1 and option 2. Adapted from reference 10. Figure 1 illustrates the two options that leave alone be examined in this economic analysis.Option 1 involves a three-unit operation harvest process centrifugation, followed by depth filtration, and completed with a concentration and fender exchange via excursive 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 options can peddle the desired product recovery (> 80%), harvest time (