Abstract
This study models two alternative downstream processes based on magnetic separation with the objective of understanding the economic feasibility of these processes compared to the traditional mAb process. The key focus lies in the economic understanding of the cell harvest and capture steps in the models. Here, the models revealed that integrating cell removal and product capture in a single operation is the main factor driving the unified productivity between USP and the magnetic bead-based processes. This results in significant economic benefits, such as savings in both the cost of goods per gram of mAb and fixed costs, as well as increasing annual facility output. The predicted savings potential approaches 38% for COGs, 17% for capital investment, and 40% for annual facility output. For mammalian cell-based manufacturing, the magnetic separation-based DSP provides a highly valuable option due to its integration of several individual unit operations compared to the traditional process both in reducing process time and cost and accommodating higher demands.
Published Version
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