Highly pure neurotoxic component of a botulinum toxin, process for preparing same, and uses thereof
US-9937245-B2 · Apr 10, 2018 · US
US10653754B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-10653754-B2 |
| Application number | US-201815881135-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jan 26, 2018 |
| Priority date | Jul 30, 2013 |
| Publication date | May 19, 2020 |
| Grant date | May 19, 2020 |
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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.
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The invention claimed is: 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.
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