Assessment of the ability of the Privigen^® purification process to deplete thrombogenic factor XIa from plasma

Abstract

The Privigen(®) manufacturing process has the capability to remove thrombogenic factors: octanoic acid precipitation, designed to remove a variety of contaminants during immunoglobulin purification, also removes almost all FXIa from plasma and further purification steps do not activate FXI.

Effects of the manufacturing process on the anti‐A isoagglutinin titers in intravenous immunoglobulin products

“…Compared with Cohn‐like purification, chromatography‐purified IVIG products have generally lower concentrations of IgA and prekallikrein activator . ‐ …”

“…Compared with Cohn-like purification, chromatography-purified IVIG products have generally lower concentrations of IgA and prekallikrein activator. 3,[7][8][9] In spite of the improvements to the purity of IVIG products, the presence of anti-A/B isoagglutinins originating from donor plasma is considered a probable cause of the rare cases of hemolysis in patients treated with IVIG products. [10][11][12][13] In this study we compared the anti-A/B isoagglutinin titers in IVIG preparations derived from Cohnlike and chromatography-based manufacturing processes.…”

Absence of in vitro Procoagulant Activity in Immunoglobulin Preparations due to Activated Coagulation Factors

“…These results also allowed us to infer that there is a lack of correlation between NAPTT and FXIa when present in very low concentrations. In fact, it has been recently reported that the NAPTT test has satisfactory sensitivity for detection of levels ≥1 ng/ml of FXIa [10]. …”

Human plasma‐derived immunoglobulin G fractionated by an aqueous two‐phase system, caprylic acid precipitation, and membrane chromatography has a high purity level and is free of detectable in vitro thrombogenic activity

“…Any residual thrombogenicity in the resuspended IgG‐enriched upper phase was precipitated or inactivated by caprylic acid (Fig. , panels A and B) .…”