Process comparison in Ypso-Proxima: EASY by Sanofi vs. classical mAb purification process
Technical and economic evaluation to reduce Cost of Goods
Thomas Prouzeau, Jerome Pezzini, and Benoit Mothes
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)
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