Production Cost Analysis

Production Cost Analysis economic Analysis as a marionette for Process Development reaping of a High Cell-Density Fermentation For the biotech industry to be profitable, it must compute economics along with butt recovery, purity, and product quality. The number of biotechnology-based human sanative products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steady increased. 1,2This has required biotech companies to use economic analysis as a tool during care for development and for making decisions about abut design.Process development efforts straight off aim to create processes that are economical, as well as optimum and robust. 3-6 pic Novais et al. recently get alonged an economic comparison of conventional versus disposables-based technology for the production of an antibody fraction from anE. colifermentation. 7The authors concluded that the capital investment required for a disposables-based option is well reducedless than 60% of that for a conventional option.The disposables-based running be were 70% higher than those of the conventional equivalent. However, the net present value of the disposables-based kit and caboodle 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 revue 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 ordinarily apply. In a recent publication, different harvest approaches were investigated for a quality study involving recovery of a therapeutic protein fromPichia pastorisfermentation broth. 10 pic configuration 1. Schematics for options 1 and 2 that are examined in this economic analysis This a rticle, the ordinal 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. stress pic Table 1. Comparison of process performance for option 1 and option 2. Adapted 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 depth filtration, and completed with a concentration and buffer transfigure via tangential pass 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 to a lower place the two options. Under optimal conditions, both options can deliver the in demand(p) product recovery ( 80%), harvest time (