Stable therapeutic proteins
The invention relates to storable medicaments produced from pharmaceutical active ingredient preparations which are virus safe. Said medicaments contain at least one intact therapeutic protein obtained from plasma or by means of genetic engineering, as an active pharmaceutical substance. Said active ingredient preparations contain active enzymes, especially proteases, which are either free or bound to the substrates thereof and act against the therapeutic protein(s) present.
1. A storable, parenteral drug composition produced from virus-safe, pharmaceutical drug substance preparations, the composition comprising (a) one or more intact therapeutic protein, wherein the therapeutic protein is selected from the group consisting of fibrinogen, Factor VIII, Factor V, Factor XIII and clotting Factors II, VII, IX and X of the prothrombin complex, and (b) an atoxic, virus-safe protease inhibitor in an amount sufficient to stabilize the therapeutic protein, wherein the protease inhibitor is C 1 -inhibitor.
2. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is free of enzymes that are active proteases or protease cascades, which activate zymogens of the enzymes.
3. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is free of any cofactors or profactors which directly or indirectly promote the activities of enzymes on the therapeutic protein contained therein.
4. The storable, parenteral drug composition according to claim 1 , wherein the one or more atoxic, virus-safe protease inhibitor inhibits the activation of zymogens by proteases or protease cascades as well as the proteolytic effect of the proteases formed from zymogens and acting against the therapeutic protein(s) present in the drug substance preparations.
5. The storable, parenteral drug composition according to claim 2 , wherein the enzyme is an active protease.
6. The storable, parenteral drug composition according to claim 2 , wherein the enzyme is a protease bound to its substrate.
7. The storable, drug composition according to claim 1 , wherein the therapeutic protein is fibrinogen.
8. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is Factor VIII.
9. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is Factor V.
10. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is Factor XIII.
11. The storable, parenteral drug composition according to claim 1 , wherein the therapeutic protein is the clotting Factors II, VII, IX and X of the prothrombin complex.