Miles Laboratories, Inc.

Robert E Jordan

Gautam Mitra

Jaleh Kilpatrick

Preparation of active therapeutic proteins comprising two essential steps. In the first step an active protein source is treated under conditions sufficient to inactivate any viruses present (e.g. via heat or chemical treatment). In the second step, the treated active protein source of moderate purity is then treated under conditions sufficient to remove impurities as well as denatured (once active) proteins resulting from the viral inactivation step. In an illustrative embodiment, a biologically active protein such as antithrombin is treated under conditions sufficient to assure viral inactivation and minimal antithrombin deactivation. After the viral inactivation, the antithrombin is contacted with immobilized heparin to complex only the active antithrombin which is then eluted by known means and processed further (e.g., to include desired excipients and then freeze dried). The preferred resulting concentrate is characterized by a high degree of purity, virus inactivation, and absence of denatured or inactive protein (generally less than about 10% by weight inactive form or, in the case of antithrombin, less than about 10% as determined, for example, by crossed immunoelectrophoresis).

Viral inactivation and purification of active proteins

There is disclosed a non-carbohydrate sulfated matrix and the use thereof to isolate and purify blood clotting factors and other blood proteins by a procedure involving the adsorption of at least one of such factors and proteins onto the non-carbohydrate sulfated matrix followed by elution of such factors and proteins onto the non-carbohydrate sulfated matrix followed by elution of such factors and proteins from the matrix.

Purfication of blood clotting factors and other blood proteins on

There is disclosed a process for producing a convalently bound heparin--antithrombin-III complex useful for anticoagulant therapy, a covalently bound heparin--antithrombin-III complex produced by the process, a composition thereof in a pharmaceutically acceptable carrier, and a method for preventing and treating thromboembolisms by administering to a human patient a therapeutically effective amount of the complex or preparation.

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Walnut Creek, CA, United States of America

Robert E Jordan