During the last years, alternatives to Protein A purification in mAb downstream processing have raised substantial interest. In parallel, the pharmaceutical industry has a growing need for reliable tools supporting process development and rational decision-making.
This article [1] illustrates the use of the software suite Ypso-Proxima to compare a classical mAb purification process with the innovative EASY process developed by Sanofi. As compared to the classical approach, which involves numerous buffer solutions and operations, EASY works in full flow-through, without protein A nor resins, and using a single buffer solution. The Costs of Goods of the two processes are estimated in Proxima based on process diagrams and associated mass balances. This allows a rational techno-economic comparison, revealing that EASY is a particularly attractive solution for campaigns with a small number of batches.
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[1] T. Prouzeau, et al., “EASY: a Disruptive mAb Purification Process to Reduce Cost of Goods,” BioPharm International 34 (1) 26–30 (2021)