IMPROVED METHODS FOR PROCESSING ACTIVATED PROTEIN C

摘要

1. An improved method of freeze drying an aqueous solution of recombinant activated protein C, comprising conducting such freeze drying at an ionic strength of greater than 150mM and a pH of about 5.5 to less than 6.3. 2. The method of claim 1 wherein protein C is human activated protein C. 3. The method of claim 2 wherein the pH is from 5.6 to 6.2. 4. The method of claim 3 wherein such solution comprises sodium chloride. 5. The method of claim 4 wherein the sodium chloride concentration is 200mM to 1000mM. 6. The method of claim 1 wherein the pH is buffered with sodium citrate. 7. A preparation of activated protein C obtainable by freeze drying a solution of activated protein C having an ionic strength of greater than 150mM and a pH of about 5.5 to less than 6.3, in the absence of a denaturing agent, histidine, lysine hydrochloride or albumin. 8. An aqueous solution of recombinant activated protein C, comprising recombinant activated protein C; said solution having an ionic strength of greater than 150mM and a pH of about 5.5 to less than 6.3 having less than 10% des(1-9) activated protein C and des(1-10) activated protein C by combined weight. 9. A pharmaceutical formulation comprising recombinant activated protein C; said formulation having less than about 10% des(1-9) activated protein C and des(1-10) activated protein C by combined weight. 10. A pharmaceutical formulation of claim 9; said formulation having less than about 5% des(1-9) activated protein C and des(1-10) activated protein C by combined weight.