Botulinum toxin pharmaceutical composition with enhanced potency
A botulinum toxin pharmaceutical formulation free of animal derived proteins, comprising a botulinum toxin and a recombinant albumin, suitable for therapeutic administration to a human patient, and methods for treating patients with various diseases and afflictions with the formulation.
1 - 19 . (canceled)
20 . A process for making a botulinum toxin pharmaceutical composition with an enhanced potency, the process comprising the step of combining a botulinum toxin and a recombinant human serum albumin, thereby obtaining a botulinum toxin pharmaceutical composition with an enhanced potency.
21 . The process of claim 20 further comprising the step, before the combining step, of obtaining a botulinum toxin.
22 . The process of claim 21 further comprising the step, before the combining step, of obtaining a recombinant albumin.
23 . the process of claim 20 , wherein the botulinum toxin pharmaceutical composition has an enhanced potency with regard to a reference botulinum toxin pharmaceutical composition.
24 . the process of claim 23 , wherein the reference botulinum toxin pharmaceutical composition contains a botulinum toxin, sodium chloride and human serum albumin.
25 . the process of claim 23 , wherein the botulinum toxin pharmaceutical composition has a potency which is from at least 5% and up to 40% greater than the potency of the reference botulinum toxin pharmaceutical composition.
26 . A process for making a botulinum toxin pharmaceutical composition, with an enhanced potency the process comprising the steps of:
(a) obtaining a botulinum toxin;
(b) obtaining a recombinant albumin and;
(c) combining the botulinum toxin and the recombinant human serum albumin to thereby obtain a botulinum toxin pharmaceutical composition with an enhanced potency.
27 . A botulinum toxin pharmaceutical composition made by the process of claim 20 .
28 . A botulinum toxin pharmaceutical composition made by the process of claim 26.