SI2920199T1 - METHOD FOR THE MANUFACTURE OF BOTULINUM TOXIN - Google Patents
METHOD FOR THE MANUFACTURE OF BOTULINUM TOXIN Download PDFInfo
- Publication number
- SI2920199T1 SI2920199T1 SI201430702T SI201430702T SI2920199T1 SI 2920199 T1 SI2920199 T1 SI 2920199T1 SI 201430702 T SI201430702 T SI 201430702T SI 201430702 T SI201430702 T SI 201430702T SI 2920199 T1 SI2920199 T1 SI 2920199T1
- Authority
- SI
- Slovenia
- Prior art keywords
- botulinum toxin
- precipitate
- acid
- buffer
- botulinum
- Prior art date
Links
- 108030001720 Bontoxilysin Proteins 0.000 title claims abstract 28
- 229940053031 botulinum toxin Drugs 0.000 title claims abstract 27
- 238000004519 manufacturing process Methods 0.000 title claims abstract 3
- 238000000034 method Methods 0.000 claims abstract 18
- 239000000872 buffer Substances 0.000 claims abstract 6
- 238000005571 anion exchange chromatography Methods 0.000 claims abstract 5
- 239000002253 acid Substances 0.000 claims abstract 4
- 239000002244 precipitate Substances 0.000 claims abstract 4
- 229940124158 Protease/peptidase inhibitor Drugs 0.000 claims abstract 3
- 239000000137 peptide hydrolase inhibitor Substances 0.000 claims abstract 3
- 101710163270 Nuclease Proteins 0.000 claims abstract 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 4
- 238000003916 acid precipitation Methods 0.000 claims 2
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 claims 2
- 229910052921 ammonium sulfate Inorganic materials 0.000 claims 2
- 235000011130 ammonium sulphate Nutrition 0.000 claims 2
- 238000000746 purification Methods 0.000 claims 2
- 239000012064 sodium phosphate buffer Substances 0.000 claims 2
- 241000193155 Clostridium botulinum Species 0.000 claims 1
- 102000016911 Deoxyribonucleases Human genes 0.000 claims 1
- 108010053770 Deoxyribonucleases Proteins 0.000 claims 1
- 102000006382 Ribonucleases Human genes 0.000 claims 1
- 108010083644 Ribonucleases Proteins 0.000 claims 1
- 108010057266 Type A Botulinum Toxins Proteins 0.000 claims 1
- 238000005349 anion exchange Methods 0.000 claims 1
- LZCZIHQBSCVGRD-UHFFFAOYSA-N benzenecarboximidamide;hydron;chloride Chemical compound [Cl-].NC(=[NH2+])C1=CC=CC=C1 LZCZIHQBSCVGRD-UHFFFAOYSA-N 0.000 claims 1
- 229940094657 botulinum toxin type a Drugs 0.000 claims 1
- 238000000605 extraction Methods 0.000 claims 1
- 239000002777 nucleoside Substances 0.000 claims 1
- 150000003833 nucleoside derivatives Chemical class 0.000 claims 1
- 238000001556 precipitation Methods 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000003053 toxin Substances 0.000 claims 1
- 231100000765 toxin Toxicity 0.000 claims 1
- 108700012359 toxins Proteins 0.000 claims 1
- 206010019468 Hemiplegia Diseases 0.000 abstract 1
- 206010008129 cerebral palsy Diseases 0.000 abstract 1
- 208000018360 neuromuscular disease Diseases 0.000 abstract 1
- 201000007770 spastic cerebral palsy Diseases 0.000 abstract 1
- 201000008417 spastic hemiplegia Diseases 0.000 abstract 1
- 230000001839 systemic circulation Effects 0.000 abstract 1
- 230000037303 wrinkles Effects 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/52—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from bacteria or Archaea
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
- C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/18—Ion-exchange chromatography
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P21/00—Preparation of peptides or proteins
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/24—Metalloendopeptidases (3.4.24)
- C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Analytical Chemistry (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Enzymes And Modification Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020130092024A KR101339349B1 (ko) | 2013-08-02 | 2013-08-02 | 보툴리눔 독소의 제조방법 |
| EP14832966.7A EP2920199B1 (en) | 2013-08-02 | 2014-05-07 | Method for production of botulinum toxin |
| PCT/KR2014/004003 WO2015016462A1 (en) | 2013-08-02 | 2014-05-07 | Method for production of botulinum toxin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2920199T1 true SI2920199T1 (en) | 2018-06-29 |
Family
ID=49987856
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI201430702T SI2920199T1 (en) | 2013-08-02 | 2014-05-07 | METHOD FOR THE MANUFACTURE OF BOTULINUM TOXIN |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US9512418B2 (en:Method) |
| EP (1) | EP2920199B1 (en:Method) |
| JP (2) | JP6307150B2 (en:Method) |
| KR (1) | KR101339349B1 (en:Method) |
| CN (1) | CN105392795B (en:Method) |
| AR (1) | AR096541A1 (en:Method) |
| AU (1) | AU2014297167B2 (en:Method) |
| BR (1) | BR112015029973B1 (en:Method) |
| CA (1) | CA2912553C (en:Method) |
| CY (1) | CY1120410T1 (en:Method) |
| DK (1) | DK2920199T3 (en:Method) |
| ES (1) | ES2665288T3 (en:Method) |
| HR (1) | HRP20180679T1 (en:Method) |
| HU (1) | HUE036840T2 (en:Method) |
| LT (1) | LT2920199T (en:Method) |
| MX (1) | MX362821B (en:Method) |
| NO (1) | NO2920199T3 (en:Method) |
| PH (1) | PH12015501855A1 (en:Method) |
| PL (1) | PL2920199T3 (en:Method) |
| PT (1) | PT2920199T (en:Method) |
| RU (1) | RU2627159C2 (en:Method) |
| SA (1) | SA515370208B1 (en:Method) |
| SG (1) | SG11201509486VA (en:Method) |
| SI (1) | SI2920199T1 (en:Method) |
| WO (1) | WO2015016462A1 (en:Method) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8129139B2 (en) | 2009-07-13 | 2012-03-06 | Allergan, Inc. | Process for obtaining botulinum neurotoxin |
| KR101339349B1 (ko) * | 2013-08-02 | 2013-12-09 | 주식회사 대웅 | 보툴리눔 독소의 제조방법 |
| KR101723167B1 (ko) | 2015-04-28 | 2017-04-05 | 주식회사 대웅 | 보툴리눔 독소의 제조를 위한 배지 조성물 |
| KR101729251B1 (ko) | 2015-04-28 | 2017-04-21 | 주식회사 대웅 | 보툴리눔 독소의 제조를 위한 배지 조성물 |
| KR101723168B1 (ko) | 2015-04-28 | 2017-04-05 | 주식회사 대웅 | 보툴리눔 독소의 제조를 위한 배지 조성물 |
| KR101853463B1 (ko) * | 2015-09-09 | 2018-06-20 | 휴젤(주) | 보툴리눔 독소의 정제 방법 |
| KR101775682B1 (ko) | 2015-11-30 | 2017-09-06 | 주식회사 대웅 | 보툴리눔 독소의 제조방법 |
| CN109641941B (zh) * | 2016-05-16 | 2023-06-16 | 哈佛大学校长及研究员协会 | 用于纯化和激活肉毒杆菌神经毒素的方法 |
| KR102463881B1 (ko) | 2016-10-04 | 2022-11-07 | (주)메디톡스 | 보툴리눔 독소 함유 용액으로부터 보툴리눔 독소를 분리하는 방법 |
| KR101744900B1 (ko) | 2017-01-20 | 2017-06-08 | 주식회사 대웅 | 보툴리눔 독소를 포함하는 안정한 액상 조성물 |
| CN109646673A (zh) * | 2017-10-12 | 2019-04-19 | 秀杰股份公司 | 肉毒杆菌毒素的微结构制剂技术 |
| CA3124535A1 (en) | 2018-12-21 | 2020-06-25 | The Research Foundation For Microbial Diseases Of Osaka University | Botulinum toxin producing method |
| KR102516204B1 (ko) * | 2019-04-15 | 2023-03-30 | (주)제테마 | 보툴리눔 독소의 정제방법 |
| KR102516203B1 (ko) * | 2019-04-15 | 2023-03-30 | (주)제테마 | 보툴리눔 독소의 제조방법 |
| TWI854077B (zh) * | 2019-12-20 | 2024-09-01 | 瑞士商葛德瑪控股公司 | 生產肉毒桿菌毒素的方法 |
| TW202136286A (zh) * | 2019-12-20 | 2021-10-01 | 瑞士商葛德瑪控股公司 | 純化肉毒桿菌毒素的方法 |
| KR102724651B1 (ko) * | 2021-07-08 | 2024-11-01 | 주식회사 파마리서치바이오 | 비-독소 단백질이 제거된 클로스트리디움 보툴리눔 신경독소 단백질의 정제방법 |
| TWI852454B (zh) * | 2022-04-01 | 2024-08-11 | 大陸商重慶譽顏製藥有限公司 | 一種肉毒毒素蛋白組合物、製備方法及其應用 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20030060150A (ko) * | 2002-01-07 | 2003-07-16 | (주)메디톡스 | 클로스트리디움 보툴리눔 ａ형 독소를 정제하는 방법 |
| RU2206337C1 (ru) * | 2002-10-29 | 2003-06-20 | Общество с ограниченной ответственностью "Токсины и сопутствующие продукты" | Лекарственный препарат для лечения мышечных дистоний и способ его получения |
| US7452697B2 (en) * | 2003-09-25 | 2008-11-18 | Allergan, Inc. | Chromatographic method and system for purifying a botulinum toxin |
| US7879341B2 (en) * | 2004-07-26 | 2011-02-01 | Merz Pharma Gmbh & Co. Kgaa | Therapeutic composition with a botulinum neurotoxin |
| AU2005327458B2 (en) * | 2005-03-03 | 2011-12-15 | Allergan, Inc. | Animal product free system and process for purifying a botulinum toxin |
| KR101025617B1 (ko) * | 2008-02-25 | 2011-03-30 | 메덱스젠 주식회사 | 클로스트리디움 보툴리눔으로부터 보툴리눔 독소를정제하는 방법 |
| US8129139B2 (en) * | 2009-07-13 | 2012-03-06 | Allergan, Inc. | Process for obtaining botulinum neurotoxin |
| HRP20181869T1 (hr) * | 2009-10-21 | 2019-01-11 | Revance Therapeutics, Inc. | Metode i sustavi za pročišćavanje nekompleksiranog botulinskog neurotoksina |
| KR101434558B1 (ko) * | 2011-07-21 | 2014-08-27 | (주)메디톡스 | 식물 유래 성분 함유 배지 및 가요성 폐쇄 용기를 이용하여 클로스트리디움 보툴리눔 독소를 생산하는 방법 |
| KR101339349B1 (ko) * | 2013-08-02 | 2013-12-09 | 주식회사 대웅 | 보툴리눔 독소의 제조방법 |
-
2013
- 2013-08-02 KR KR1020130092024A patent/KR101339349B1/ko active Active
-
2014
- 2014-05-07 US US14/654,819 patent/US9512418B2/en active Active
- 2014-05-07 PT PT148329667T patent/PT2920199T/pt unknown
- 2014-05-07 JP JP2016506267A patent/JP6307150B2/ja active Active
- 2014-05-07 HU HUE14832966A patent/HUE036840T2/hu unknown
- 2014-05-07 EP EP14832966.7A patent/EP2920199B1/en active Active
- 2014-05-07 MX MX2015016481A patent/MX362821B/es active IP Right Grant
- 2014-05-07 BR BR112015029973-3A patent/BR112015029973B1/pt active IP Right Grant
- 2014-05-07 RU RU2015151186A patent/RU2627159C2/ru active
- 2014-05-07 HR HRP20180679TT patent/HRP20180679T1/hr unknown
- 2014-05-07 PL PL14832966T patent/PL2920199T3/pl unknown
- 2014-05-07 ES ES14832966.7T patent/ES2665288T3/es active Active
- 2014-05-07 CA CA2912553A patent/CA2912553C/en active Active
- 2014-05-07 NO NO14832966A patent/NO2920199T3/no unknown
- 2014-05-07 CN CN201480012202.6A patent/CN105392795B/zh active Active
- 2014-05-07 SI SI201430702T patent/SI2920199T1/en unknown
- 2014-05-07 WO PCT/KR2014/004003 patent/WO2015016462A1/en not_active Ceased
- 2014-05-07 DK DK14832966.7T patent/DK2920199T3/en active
- 2014-05-07 LT LTEP14832966.7T patent/LT2920199T/lt unknown
- 2014-05-07 AU AU2014297167A patent/AU2014297167B2/en active Active
- 2014-05-07 SG SG11201509486VA patent/SG11201509486VA/en unknown
- 2014-06-06 AR ARP140102204A patent/AR096541A1/es active IP Right Grant
-
2015
- 2015-08-24 PH PH12015501855A patent/PH12015501855A1/en unknown
- 2015-11-29 SA SA515370208A patent/SA515370208B1/ar unknown
-
2017
- 2017-03-06 JP JP2017041239A patent/JP2017141237A/ja active Pending
-
2018
- 2018-04-26 CY CY20181100439T patent/CY1120410T1/el unknown
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