Highly pure neurotoxic component of a botulinum toxin and uses thereof

US10653754B2 · US · B2

Patent metadata
FieldValue
Publication numberUS-10653754-B2
Application numberUS-201815881135-A
CountryUS
Kind codeB2
Filing dateJan 26, 2018
Priority dateJul 30, 2013
Publication dateMay 19, 2020
Grant dateMay 19, 2020

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  1. Title

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  2. Abstract

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  3. Assignees and inventors

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  4. Key dates

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  5. First independent claim

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  6. CPC / IPC classifications

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  7. Citations and related patents

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Abstract

Official abstract text for this publication.

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.

First claim

Opening claim text (preview).

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.

Assignees

Inventors

Classifications

  • from Clostridium (G) · CPC title

  • Clostridium, e.g. Clostridium tetani · CPC title

  • Drugs for disorders of the muscular or neuromuscular system · CPC title

  • for peripheral neuropathies · CPC title

  • derived from bacteria {or Archaea} · CPC title

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Frequently asked questions

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What does patent US10653754B2 cover?
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 p…
Who is the assignee on this patent?
Merz Pharma Gmbh & Co Kgaa, Merz Pharmaceuticals Gmbh
What technology area does this patent fall under?
Primary CPC classification A61K38/4893. Mapped technology areas include Human Necessities.
When was this patent published?
Publication date Tue May 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
What related patents are in patentsdb?
We list 3 related publications on this page (citations in our corpus or others sharing the same primary CPC).