Method to manufacture a stable protein

Abstract

A Clostridial toxin pharmaceutical composition comprising a Clostridial toxin, such as a botulinum toxin, wherein the Clostridial toxin present in the pharmaceutical composition is stabilized by a non-protein excipient such as a polyvinylpyrrolidone, a disaccharide, a trisaccharide, a polysaccharide, an alcohol, a metal, an amino acid, a surfactant and/or a polyethylene glycol.

I claim: 
     
         1 . A method to stabilize a toxin that cleaves SNAP-25, comprising:
 compounding to form a liquid pharmaceutical composition a Clostridial neurotoxin and two or more non-protein excipients, wherein the non-protein excipients are non-immunogenic response injected into a human and effective to stabilize the Clostridial neurotoxin for activity to cleave SNAP-25.   
     
     
         2 . The method of  claim 1 , wherein compounding comprises adding the non-protein stabilizer to water to form a solution and adding the Clostridial neurotoxin to the solution to form a toxin formulation. 
     
     
         3 . The method of  claim 2 , wherein the toxin formulation is an aqueous solution.