Botulinum toxin neurotoxic components formulations

1 - 16 . (canceled)

17 . A vacuum dried, sterile, lyophilised, powdered formulation for therapeutic use in humans comprising:

(a) the neurotoxic component of a botulinum toxin purified from a complex of non-toxic proteins and haemagglutinins, wherein the neurotoxic component has a molecular weight of about 150 kilodaltons and comprises a short polypeptide chain of about 50 kD and a larger polypeptide chain of about 100 kD;

(b) saline, and;

(c) pasteurised human serum albumin.

18 . A method for making a neurotoxic component botulinum toxin formulation comprising the steps of:

(a) establishing a culture of an anaerobic bacterium of Clostridium botulinum;

(b) growing a culture of the Clostridium botulinum in a fermenter;

(c) harvesting a botulinum toxin type A mixture from the fermenter, wherein the botulinum toxin type A harvested comprises;

(i) a neurotoxic polypeptide component with

( 1 ) a molecular weight of about 150 kilodaltons,

( 2 ) a short polypeptide chain of about 50 kD, and

( 3 ) a larger polypeptide chain of about 100 kD,

( 4 ) the two chains being linked together by a disulphide bridge,

(ii) a complex comprising

( 5 ) non-toxic proteins and

( 6 ) haemagglutinins,

( 7 ) the complex having a molecular weight of about 900 kD;

(d) purifying the botulinum toxin type A neurotoxic component from the fermented mixture;

(e) adding human serum albumin as a stabilizer to the botulinum toxin type A;

(f) adding saline as a tonicity adjusting agent to the botulinum toxin type A to form a solution;

(g) sterile filtering the solution;

(h) vacuum drying the solution to form a powder;

(i) reconstituting the powder with sterile unpreserved normal saline to form a sterile, pyrogen-free aqueous solution or dispersion of a botulinum toxin type A neurotoxic component.

19 . A product made by the method of claim 18.