Animal product free media and processes for obtaining a botulinum toxin
AssigneeAllergan, Inc.
InventorStephen Donovan
Life of this patent
Estimating the term…
Abstract
Media and processes for the fermentation of Clostridium botulinum and obtaining a botulinum toxin for use in formulating botulinum toxin pharmaceutical compositions. The growth media can contain significantly reduced levels of meat or dairy by-products using non-animal based products to replace the animal-derived products. Preferably, the media used are substantially free of animal derived products.
Claims10
A method for obtaining a biologically active botulinum toxin, comprising the steps of:
- (a) providing a fermentation medium free of an animal derived product;
- (b) culturing a Clostridium botulinum bacterium in the fermentation medium under conditions which permit production of a botulinum toxin, and;
- (c) recovering a biologically active botulinum toxin from the fermentation medium, wherein the fermentation medium comprises a protein product obtained from soy or Lupinus campestris and further includes glucose.
A method for production of a botulinum toxin, the method comprising steps of:
- (a) providing a first medium that is free of an animal derived product and that comprises a soy or Lupinus campestris protein product and further includes glucose;
- (b) culturing a Clostridium botulinum bacterium in the first medium under conditions that permit growth of the Clostridium botulinum;
- (c) providing a second medium that is free of an animal derived product and that comprises a soy or Lupinus campestris protein product and further includes glucose;
- (d) inoculating the second medium with the first medium;
- (e) culturing the Clostridium botulinum bacterium in the second medium under conditions that allow production of a botulinum toxin, and
- (f) recovering the botulinum toxin.
A composition comprising a Clostridium botulinum and a culture medium for producing a botulinum toxin wherein the medium is free of an animal derived product and comprises a soy or Lupinus campestris protein product and further includes glucose.
A method for making a substantially animal product free pharmaceutical composition in which the active ingredient is a botulinum toxin, the method comprising the steps of:
- (a) obtaining a biologically active botulinum toxin by:
- (i) providing a fermentation medium that is free of an animal derived product and includes a protein product obtained from soy or Lupinus campestris and further includes glucose;
- (ii) culturing a Clostridium botulinum in the fermentation medium under conditions which permit production of a botulinum toxin;
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- (iii) recovering a biologically active botulinum toxin from the fermentation medium;
- (b) formulating the botulinum toxin with a suitable excipient, thereby making a substantially animal product free pharmaceutical composition in which the active ingredient is a botulinum toxin.
Dependencies are inferred from the claim text.