Highly pure neurotoxic component of a botulinum toxin and uses thereof
The present invention relates to a process for preparing a highly pure neurotoxic component of a botulinum toxin by cultivating Clostridium botulinum under conditions that allow production of a botulinum toxin, and isolating the neurotoxic component from the botulinum toxin. In addition, the present invention relates to a highly pure neurotoxic component of a botulinum toxin obtainable by the process of the present invention and uses thereof.
1. A highly pure neurotoxic component of a Clostridium botulinum toxin having a single-chain content of less than 1.70 wt. %, and a total purity of at least 99.90 wt. %.
2. The highly pure neurotoxic component of claim 1 , further having an endotoxin content of 5.0 IU/ml or less and/or a total aerobic viable cell count of less than 1 cfu/ml.
3. A pharmaceutical composition comprising a highly pure neurotoxic component of a Clostridium botulinum toxin according to claim 1 and one or more pharmaceutically acceptable carriers.
4. A medicament comprising the highly pure neurotoxic component of a Clostridium botulinum toxin according to claim 1 .
5. The highly pure neurotoxic component of claim 1 , having a total purity of at least 99.95 wt. %.
6. The highly pure neurotoxic component of claim 1 , having a total purity of at least 99.99 wt. %.
7. The highly pure neurotoxic component of claim 1 , having an endotoxin content of 1.0 IU/ml or less and/or a total aerobic viable cell count of less than 0.5 cfu/ml.
8. The highly pure neurotoxic component of claim 7 , having a total aerobic viable cell count of 0 cfu/ml.
9. The highly pure neurotoxic component of claim 1 , wherein the single-chain content is <1.20 wt. %.
10. The highly pure neurotoxic component of claim 1 , wherein the single-chain content is less than 1.60 wt. %.
11. The highly pure neurotoxic component of claim 1 , wherein the single-chain content is less than 1.00 wt. %.
12. The highly pure neurotoxic component of claim 1 , wherein the single-chain content is less than 0.80 wt. %.
13. The highly pure neurotoxic component of claim 1 , wherein the neurotoxic component has a biological activity in an LD 50 assay of 4.0 to 8.0 pg protein/LD 50 unit.
14. The highly pure neurotoxic component of claim 1 , wherein the neurotoxic component has a biological activity in an LD 50 assay of 5.0 to 6.0 pg protein/LD 50 unit.
15. The pharmaceutical composition of claim 3 , further comprising one or more additional active substance.