Purity, Activity, and Virus Safety of a Pasteurized Antithrombin Concentrate

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Abstract
Products derived from human plasma are employed for a wide variety of indications, including immunoglobulins for passive immunization,[ 1 ] clotting factors for the treatment of patients with hemophilia and related diseases,[ 2 ] [ 3 ] [ 4 ] [ 5 ] albumin for volume restoration,[ 6 ] and fibrin sealants for vascular and other surgical applications.[ 7 ] The purity and safety of these and other products derived from human plasma are sources of continuing concern.[ 8 ] [ 9 ] Antithrombin (AT) is a plasmatic protease inhibitor that controls many clotting factors[ 10 ] [ 11 ] and that also has anti-inflammatory actions that are independent of its effects on coagulation.[ 12 ] [ 13 ] [ 14 ] [ 15 ] [ 16 ] AT has been used effectively for the treatment of hereditary and acquired AT deficiencies.[ 17 ] This article summarizes the manufacturing process for Kybernin P, a pasteurized AT concentrate, and presents new data related to its purity, activity, and virus safety.

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