Viral inactivation and purification of active proteins

Details Viral inactivation and purification of active proteins Viral inactivation and purification of active proteins

C - Chemistry, Metallurgy

07

K

530/15.14, 530/3

C07K 1/22 (2006.01) A61L 2/00 (2006.01) C07K 1/36 (2006.01) C07K 14/81 (2006.01) C12N 7/04 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1341269

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).

541758

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