Single-use and traditional approach of clarification

The ongoing optimization of mammalian cell lines and fermentation processes leads to higher cell densities/titers and higher monoclonal antibody (mAb) yields. Due to this optimization also the biomass increases, including cell debris and other impurities, which challenges the clarification/harvest step.

The typical clarification process for mammalian cells and mAb involves a primary and a secondary clarification step. Due to potentially high shear forces and the necessity of this step to remove submicron particles, depth filtration is a mandatory step before transferring the liquid into the downstream.