JP2018533977A5 - - Google Patents
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- Publication number
- JP2018533977A5 JP2018533977A5 JP2018540360A JP2018540360A JP2018533977A5 JP 2018533977 A5 JP2018533977 A5 JP 2018533977A5 JP 2018540360 A JP2018540360 A JP 2018540360A JP 2018540360 A JP2018540360 A JP 2018540360A JP 2018533977 A5 JP2018533977 A5 JP 2018533977A5
- Authority
- JP
- Japan
- Prior art keywords
- botulinum toxin
- producing
- exchange chromatography
- toxin according
- anion exchange
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 108030001720 Bontoxilysin Proteins 0.000 claims description 101
- 229940053031 botulinum toxin Drugs 0.000 claims description 101
- 238000004519 manufacturing process Methods 0.000 claims description 49
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 27
- 238000005571 anion exchange chromatography Methods 0.000 claims description 27
- 239000000872 buffer Substances 0.000 claims description 13
- 239000002244 precipitate Substances 0.000 claims description 11
- 238000011118 depth filtration Methods 0.000 claims description 10
- 238000000034 method Methods 0.000 claims description 10
- 239000012064 sodium phosphate buffer Substances 0.000 claims description 10
- 238000000108 ultra-filtration Methods 0.000 claims description 10
- 239000000243 solution Substances 0.000 claims description 9
- 238000003916 acid precipitation Methods 0.000 claims description 8
- 238000005277 cation exchange chromatography Methods 0.000 claims description 8
- 238000011026 diafiltration Methods 0.000 claims description 6
- QKNYBSVHEMOAJP-UHFFFAOYSA-N 2-amino-2-(hydroxymethyl)propane-1,3-diol;hydron;chloride Chemical compound Cl.OCC(N)(CO)CO QKNYBSVHEMOAJP-UHFFFAOYSA-N 0.000 claims description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 4
- 239000007853 buffer solution Substances 0.000 claims description 4
- 238000000502 dialysis Methods 0.000 claims description 4
- 238000011140 membrane chromatography Methods 0.000 claims description 4
- 238000001471 micro-filtration Methods 0.000 claims description 4
- 239000011347 resin Substances 0.000 claims description 4
- 229920005989 resin Polymers 0.000 claims description 4
- 238000001914 filtration Methods 0.000 claims description 3
- 241000193155 Clostridium botulinum Species 0.000 claims description 2
- 108010057266 Type A Botulinum Toxins Proteins 0.000 claims description 2
- 239000002253 acid Substances 0.000 claims description 2
- 238000010306 acid treatment Methods 0.000 claims description 2
- 238000005352 clarification Methods 0.000 claims description 2
- 238000004440 column chromatography Methods 0.000 claims description 2
- 230000002572 peristaltic effect Effects 0.000 claims description 2
- 239000011148 porous material Substances 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 238000004659 sterilization and disinfection Methods 0.000 claims description 2
- 238000004448 titration Methods 0.000 claims description 2
- 239000003053 toxin Substances 0.000 claims description 2
- 231100000765 toxin Toxicity 0.000 claims description 2
- 238000007865 diluting Methods 0.000 claims 1
- 239000006166 lysate Substances 0.000 claims 1
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 description 3
- 229910052921 ammonium sulfate Inorganic materials 0.000 description 3
- 238000012870 ammonium sulfate precipitation Methods 0.000 description 3
- 235000011130 ammonium sulphate Nutrition 0.000 description 3
- 238000005119 centrifugation Methods 0.000 description 1
- 239000012465 retentate Substances 0.000 description 1
- 238000011146 sterile filtration Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2015-0168196 | 2015-11-30 | ||
| KR1020150168196A KR101775682B1 (ko) | 2015-11-30 | 2015-11-30 | 보툴리눔 독소의 제조방법 |
| PCT/KR2016/013506 WO2017095062A1 (en) | 2015-11-30 | 2016-11-23 | Method for producing botulinum toxin |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018533977A JP2018533977A (ja) | 2018-11-22 |
| JP2018533977A5 true JP2018533977A5 (enExample) | 2019-07-25 |
| JP6574528B2 JP6574528B2 (ja) | 2019-09-11 |
Family
ID=58797138
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018540360A Active JP6574528B2 (ja) | 2015-11-30 | 2016-11-23 | ボツリヌス毒素の製造方法 |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US10619143B2 (enExample) |
| EP (1) | EP3383889A4 (enExample) |
| JP (1) | JP6574528B2 (enExample) |
| KR (1) | KR101775682B1 (enExample) |
| CN (1) | CN108350043B (enExample) |
| AR (1) | AR107218A1 (enExample) |
| AU (2) | AU2016364597B2 (enExample) |
| BR (1) | BR112018007679A2 (enExample) |
| CA (1) | CA2997698C (enExample) |
| MX (1) | MX2018004650A (enExample) |
| RU (1) | RU2707255C1 (enExample) |
| TW (1) | TWI623549B (enExample) |
| WO (1) | WO2017095062A1 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8129139B2 (en) | 2009-07-13 | 2012-03-06 | Allergan, Inc. | Process for obtaining botulinum neurotoxin |
| JP5951490B2 (ja) * | 2009-10-21 | 2016-07-13 | ルバンス セラピュティックス インク．Ｒｅｖａｎｃｅ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | 非複合ボツリヌス神経毒素を精製するための方法およびシステム |
| KR101723168B1 (ko) * | 2015-04-28 | 2017-04-05 | 주식회사 대웅 | 보툴리눔 독소의 제조를 위한 배지 조성물 |
| KR102463881B1 (ko) * | 2016-10-04 | 2022-11-07 | (주)메디톡스 | 보툴리눔 독소 함유 용액으로부터 보툴리눔 독소를 분리하는 방법 |
| KR102516203B1 (ko) * | 2019-04-15 | 2023-03-30 | (주)제테마 | 보툴리눔 독소의 제조방법 |
| KR102516204B1 (ko) * | 2019-04-15 | 2023-03-30 | (주)제테마 | 보툴리눔 독소의 정제방법 |
| EP3962924A1 (en) * | 2019-05-03 | 2022-03-09 | Genentech, Inc. | Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform |
| KR102287437B1 (ko) * | 2019-08-14 | 2021-08-09 | 주식회사 프로톡스 | 보툴리눔 독소의 제조방법 |
| 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 |
| CN112480221A (zh) * | 2020-12-02 | 2021-03-12 | 湖北省农业科学院畜牧兽医研究所 | 产气荚膜梭菌毒素抗原浓缩工艺 |
| KR102724651B1 (ko) * | 2021-07-08 | 2024-11-01 | 주식회사 파마리서치바이오 | 비-독소 단백질이 제거된 클로스트리디움 보툴리눔 신경독소 단백질의 정제방법 |
| CO2023018742A1 (es) * | 2023-12-29 | 2025-07-07 | Lifefactors S A S | Proceso de purificación de macromoléculas con etapas de precipitación selectiva, concentración y diálisis combinadas en condiciones constantes de estabilidad con el cual se obtienen formulaciones estables y de alta pureza |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06192296A (ja) | 1992-10-28 | 1994-07-12 | Chiba Pref Gov | 治療用医薬品としての結晶ａ型ボツリヌス毒素の製造法。 |
| JPH06199296A (ja) | 1992-12-29 | 1994-07-19 | Toyota Motor Corp | ガスタービンエンジンを推進力とする水上飛行機 |
| DE19925739A1 (de) * | 1999-06-07 | 2000-12-21 | Biotecon Ges Fuer Biotechnologische Entwicklung & Consulting Mbh | Therapeutikum mit einem Botulinum-Neurotoxin |
| GB9914743D0 (en) * | 1999-06-24 | 1999-08-25 | Knoll Ag | Therapeutic agents |
| KR20030060150A (ko) * | 2002-01-07 | 2003-07-16 | (주)메디톡스 | 클로스트리디움 보툴리눔 ａ형 독소를 정제하는 방법 |
| US7452697B2 (en) * | 2003-09-25 | 2008-11-18 | Allergan, Inc. | Chromatographic method and system for purifying a botulinum toxin |
| CN1930186A (zh) * | 2005-03-03 | 2007-03-14 | 阿勒根公司 | 为获得梭菌毒素的梭菌细菌培养基及方法 |
| KR101025617B1 (ko) | 2008-02-25 | 2011-03-30 | 메덱스젠 주식회사 | 클로스트리디움 보툴리눔으로부터 보툴리눔 독소를정제하는 방법 |
| KR20090120222A (ko) * | 2008-05-19 | 2009-11-24 | (주)메디톡스 | 식물 유래 성분 함유 배지 및 가요성 폐쇄 용기를 이용하여클로스트리디움 보툴리눔 독소를 생산하는 방법 |
| US8129139B2 (en) * | 2009-07-13 | 2012-03-06 | Allergan, Inc. | Process for obtaining botulinum neurotoxin |
| JP2011074025A (ja) * | 2009-09-30 | 2011-04-14 | Chemo-Sero-Therapeutic Research Inst | ボツリヌス毒素の精製方法 |
| JP5951490B2 (ja) | 2009-10-21 | 2016-07-13 | ルバンス セラピュティックス インク．Ｒｅｖａｎｃｅ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． | 非複合ボツリヌス神経毒素を精製するための方法およびシステム |
| KR101134146B1 (ko) * | 2010-05-31 | 2012-04-19 | 메덱스젠 주식회사 | 국소 근마비 효과를 갖는 비확산형 보툴리눔 독소와 그의 정제방법 |
| UY33452A (es) | 2010-06-16 | 2012-01-31 | Bayer Schering Pharma Ag | Triazolopiridinas sustituidas |
| KR101339349B1 (ko) * | 2013-08-02 | 2013-12-09 | 주식회사 대웅 | 보툴리눔 독소의 제조방법 |
-
2015
- 2015-11-30 KR KR1020150168196A patent/KR101775682B1/ko active Active
-
2016
- 2016-11-23 WO PCT/KR2016/013506 patent/WO2017095062A1/en not_active Ceased
- 2016-11-23 JP JP2018540360A patent/JP6574528B2/ja active Active
- 2016-11-23 CA CA2997698A patent/CA2997698C/en active Active
- 2016-11-23 BR BR112018007679A patent/BR112018007679A2/pt active Search and Examination
- 2016-11-23 US US15/758,042 patent/US10619143B2/en active Active
- 2016-11-23 RU RU2018113925A patent/RU2707255C1/ru active
- 2016-11-23 CN CN201680061642.XA patent/CN108350043B/zh active Active
- 2016-11-23 AU AU2016364597A patent/AU2016364597B2/en active Active
- 2016-11-23 EP EP16870958.2A patent/EP3383889A4/en active Pending
- 2016-11-23 MX MX2018004650A patent/MX2018004650A/es unknown
- 2016-11-29 AR ARP160103642A patent/AR107218A1/es unknown
- 2016-11-30 TW TW105139480A patent/TWI623549B/zh active
-
2019
- 2019-02-26 AU AU2019201315A patent/AU2019201315B2/en active Active
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