Method for monomerizing matrix metalloproteinase 7 (mmp-7) aggregate

Abstract

A method for monomerization of MMP-7 aggregates is provided. A method for monomerization of MMP-7 aggregates which comprises treating MMP-7 aggregates with a buffer solution comprising a monovalent cation chloride (sodium chloride, potassium chloride, etc.) at a low concentration or with a buffer solution not comprising a monovalent cation chloride, a process for preparing MMP-7 which involves said method for monomerization, and a (pharmaceutical) composition comprising MMP-7 in the aforementioned buffer solution. In case that a (pharmaceutical) composition comprising MMP-7 at a low concentration is prepared, the aforementioned buffer solution comprising sugar alcohols or sugars is used.

1 - 25 . (canceled) 
     
     
         26 . A (pharmaceutical) composition comprising matrix metalloproteinase 7 (MMP-7) as an active ingredient in a solution comprising a monovalent cation compound at 130 mM or less or in a solution not comprising a monovalent cation compound. 
     
     
         27 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the composition comprises MMP-7 as an active ingredient in a solution comprising a monovalent cation compound at 130 mM or less. 
     
     
         28 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the composition comprises MMP-7 as an active ingredient in a solution not comprising a monovalent cation compound. 
     
     
         29 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the monovalent cation compound is selected from the group consisting of sodium chloride, potassium chloride, sodium sulfate, potassium sulfate, sodium carbonate, potassium carbonate, sodium phosphate and potassium phosphate. 
     
     
         30 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the monovalent cation compound is from a monovalent cation chloride. 
     
     
         31 . The (pharmaceutical) composition comprising MMP-7 according to  claim 30  wherein the monovalent cation compound is selected from the group consisting of sodium chloride and potassium chloride. 
     
     
         32 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the composition further comprises calcium chloride. 
     
     
         33 . The (pharmaceutical) composition comprising MMP-7 according to  claim 32  wherein the calcium chloride is at 30 mM or less. 
     
     
         34 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the solution is a buffer solution. 
     
     
         35 . The (pharmaceutical) composition comprising MMP-7 according to  claim 34  wherein the buffer solution is 5 to 25 mM Tris buffer. 
     
     
         36 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the MMP-7 is at 20 mg/ml or less. 
     
     
         37 . The (pharmaceutical) composition comprising MMP-7 according to  claim 36  wherein the MMP-7 is at 1 μg/ml to 1 mg/ml. 
     
     
         38 . The (pharmaceutical) composition comprising MMP-7 according to  claim 35  wherein the solution is 5 to 25 mM Tris buffer (pH 6 to 8) comprising 30 to 40 mM sodium chloride and 5 to 30 mM calcium chloride. 
     
     
         39 . The (pharmaceutical) composition comprising MMP-7 according to  claim 26  wherein the solution further comprises sugar alcohols and/or sugars. 
     
     
         40 . The (pharmaceutical) composition comprising MMP-7 according to  claim 39  wherein the sugar alcohols and/or sugars are selected from the group consisting of sucrose, lactose, maltose, xylose, trehalose, mannitol, sorbitol, xylitol, maltitol, lactitol, and oligosaccharide alcohols. 
     
     
         41 . The (pharmaceutical) composition comprising MMP-7 according to  claim 39  wherein the sugar alcohols and/or sugars are at 2% or more. 
     
     
         42 . The (pharmaceutical) composition comprising MMP-7 according to  claim 41  wherein the sugar alcohols and/or sugars are at 2 to 7%. 
     
     
         43 . The (pharmaceutical) composition comprising MMP-7 according to  claim 40  wherein the sugar alcohols and/or sugars are mannitol or sucrose. 
     
     
         44 . The (pharmaceutical) composition comprising MMP-7 according to  claim 43  wherein the mannitol is at 2 to 5% and the sucrose is at 2 to 7%. 
     
     
         45 . A solid (pharmaceutical) composition comprising MMP-7 wherein the composition can be dissolved in a solvent and the composition upon dissolution is the composition as set forth in  claim 26 . 
     
     
         46 . (canceled)