“…Allied with chemical inactivation, nanofiltration (NF) is the main process step dedicated to viral removal by most manufacturers. The performance of CEL-based virus-retentive filters (typically Planova™ filters from Asahi Kasei Medical, Tokyo, Japan) in the downstream purification processes of biopharmaceuticals has been detailed in a recent review [10]. For instance, the purification process for Nuwiq®, a recombinant coagulation factor VIII (a blood-clotting protein whose deficiency is associated with hemophilia A) patented by Octapharma AG (Lachen, Switzerland) [195], includes solvent/detergent (S/D) treatment, Planova NF, and five chromatography steps using PS-based stationary phases, i.e., MMC (Capto MMC), CEC (SP Seph FF), AFC (VIIISelect, a Capto matrix with factor VIIIselective ligand), AEC (Q Seph FF) and SEC (Superdex 200).…”