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

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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