BR112018007679A2 - método para produzir uma toxina botulínica - Google Patents

método para produzir uma toxina botulínica

Info

Publication number
BR112018007679A2
BR112018007679A2 BR112018007679A BR112018007679A BR112018007679A2 BR 112018007679 A2 BR112018007679 A2 BR 112018007679A2 BR 112018007679 A BR112018007679 A BR 112018007679A BR 112018007679 A BR112018007679 A BR 112018007679A BR 112018007679 A2 BR112018007679 A2 BR 112018007679A2
Authority
BR
Brazil
Prior art keywords
botulinum toxin
precipitate
buffer
ammonium sulfate
hydrochloric acid
Prior art date
Application number
BR112018007679A
Other languages
English (en)
Inventor
Sei Kim Chung
Sul Hye-Young
Kim Kyoung-Yun
Seob KIM Myung
Original Assignee
Daewoong Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Daewoong Co Ltd filed Critical Daewoong Co Ltd
Publication of BR112018007679A2 publication Critical patent/BR112018007679A2/pt

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/147—Microfiltration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/58—Multistep processes
    • 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
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/16—Diafiltration

Landscapes

  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Water Supply & Treatment (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

método para produzir uma toxina botulínica compreendendo as etapas:(a) tratar uma cultura de uma cepa produtora de toxina botulínica com ácido para formar um precipitado contendo toxina botulínica; (b) adicionar um tampão ao precipitado contendo toxina botulínica da etapa (a), seguido por clarificação de pelo menos um método selecionado do grupo que consiste em filtração de profundidade (df), microfiltração (mf), ultrafiltração (uf), filtração estéril, cromatografia por membrana (mc) e centrifugação; (c) submeter a solução contendo a toxina botulínica da etapa (b) para diafiltração uf, precipitação por sulfato de amônio ou precipitação por ácido clorídrico, e, em seguida, diluindo um retentado resultante da diafiltração uf em um tampão ou dissolvendo um precipitado resultante da precipitação por sulfato de amônio ou precipitado de ácido clorídrico em um tampão; e (d) submeter a diluição do retentado, solução de precipitado em sulfato de amônio ou solução em precipitado de ácido clorídrico da etapa (c) para cromatografia de troca aniônica (aex) para purificar a toxina botulínica.
BR112018007679A 2015-11-30 2016-11-23 método para produzir uma toxina botulínica BR112018007679A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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 (1)

Publication Number Publication Date
BR112018007679A2 true BR112018007679A2 (pt) 2018-11-06

Family

ID=58797138

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018007679A BR112018007679A2 (pt) 2015-11-30 2016-11-23 método para produzir uma toxina botulínica

Country Status (13)

Country Link
US (1) US10619143B2 (pt)
EP (1) EP3383889A4 (pt)
JP (1) JP6574528B2 (pt)
KR (1) KR101775682B1 (pt)
CN (1) CN108350043B (pt)
AR (1) AR107218A1 (pt)
AU (2) AU2016364597B2 (pt)
BR (1) BR112018007679A2 (pt)
CA (1) CA2997698C (pt)
MX (1) MX2018004650A (pt)
RU (1) RU2707255C1 (pt)
TW (1) TWI623549B (pt)
WO (1) WO2017095062A1 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK2490986T4 (da) * 2009-10-21 2024-06-17 Revance Therapeutics Inc Fremgangsmåder og systemer til oprensning af ikke-kompleksbundet botulinum-neurotoksin
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
KR102485146B1 (ko) * 2019-04-15 2023-01-06 (주)제테마 보툴리눔 독소의 제조방법
KR102516203B1 (ko) * 2019-04-15 2023-03-30 (주)제테마 보툴리눔 독소의 제조방법
SG11202111938YA (en) * 2019-05-03 2021-11-29 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
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
KR20230009178A (ko) * 2021-07-08 2023-01-17 주식회사 파마리서치바이오 비-독소 단백질이 제거된 클로스트리디움 보툴리눔 신경독소 단백질의 정제방법

Family Cites Families (14)

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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
US7452697B2 (en) * 2003-09-25 2008-11-18 Allergan, Inc. Chromatographic method and system for purifying a botulinum toxin
CA2556537A1 (en) 2005-03-03 2006-09-03 Allergan, Inc. Media for clostridium bacterium and processes for obtaining a clostridial toxin
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
DK2490986T4 (da) * 2009-10-21 2024-06-17 Revance Therapeutics Inc Fremgangsmåder og systemer til oprensning af ikke-kompleksbundet botulinum-neurotoksin
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

Also Published As

Publication number Publication date
RU2707255C1 (ru) 2019-11-25
EP3383889A1 (en) 2018-10-10
EP3383889A4 (en) 2019-07-17
AU2019201315A1 (en) 2019-03-21
TWI623549B (zh) 2018-05-11
CN108350043B (zh) 2022-06-14
US20180251741A1 (en) 2018-09-06
US10619143B2 (en) 2020-04-14
JP2018533977A (ja) 2018-11-22
AU2016364597B2 (en) 2019-01-17
AR107218A1 (es) 2018-04-11
CN108350043A (zh) 2018-07-31
TW201726703A (zh) 2017-08-01
MX2018004650A (es) 2018-08-15
CA2997698C (en) 2021-04-20
KR20170062694A (ko) 2017-06-08
AU2019201315B2 (en) 2020-10-15
WO2017095062A1 (en) 2017-06-08
AU2016364597A1 (en) 2018-04-12
JP6574528B2 (ja) 2019-09-11
CA2997698A1 (en) 2017-06-08
KR101775682B1 (ko) 2017-09-06

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]