Efficient Removal of Activated Coagulation Factor XI (FXIa) from Cohn Fraction II Paste Using Mixed Mode Ligand 

During the cold ethanol plasma fractionation process Factor XI (FXI) remains a challenge because of its co-precipitations with IgG. FXIa has been shown to induce activation of blood clot formation, posing a life-threatening risk to patients.  The aim of this study was to evaluate the removal of FXIa from Fraction II paste (containing mainly IgG) using a , a novel multimodal ligand, as an alternative to standard affinity-based resin chromatography. The multimodal chromatographic purification approach was proven to selectively bind FXIa.  

The data presented demonstrate that the use of the CIMmultus^® SO4 allows: 

• High binding capacity of FXIa, 

• Highly reproducible results, 

• High IgG recovery,  

• Efficient scale-up and 

• Consistent results across all 20 CIP cycles in 0.5 NaOH and 2 M NaCl.