CN108350043B - 用于产生肉毒杆菌毒素的方法 - Google Patents

用于产生肉毒杆菌毒素的方法 Download PDF

Info

Publication number
CN108350043B
CN108350043B CN201680061642.XA CN201680061642A CN108350043B CN 108350043 B CN108350043 B CN 108350043B CN 201680061642 A CN201680061642 A CN 201680061642A CN 108350043 B CN108350043 B CN 108350043B
Authority
CN
China
Prior art keywords
botulinum toxin
exchange chromatography
anion exchange
buffer
fraction
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.)
Active
Application number
CN201680061642.XA
Other languages
English (en)
Chinese (zh)
Other versions
CN108350043A (zh
Inventor
金敬伦
金清世
金明燮
薛憓莹
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daewoong Co Ltd
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 CN108350043A publication Critical patent/CN108350043A/zh
Application granted granted Critical
Publication of CN108350043B publication Critical patent/CN108350043B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • 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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Toxicology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CN201680061642.XA 2015-11-30 2016-11-23 用于产生肉毒杆菌毒素的方法 Active CN108350043B (zh)

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 (2)

Publication Number Publication Date
CN108350043A CN108350043A (zh) 2018-07-31
CN108350043B true CN108350043B (zh) 2022-06-14

Family

ID=58797138

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201680061642.XA Active CN108350043B (zh) 2015-11-30 2016-11-23 用于产生肉毒杆菌毒素的方法

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)

* Cited by examiner, † Cited by third party
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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2005327458A1 (en) * 2005-03-03 2006-10-05 Allergan, Inc. Animal product free system and process for purifying a botulinum toxin
CN101062009A (zh) * 1999-06-07 2007-10-31 莫茨药物股份两合公司 含肉毒神经毒素的治疗剂

Family Cites Families (13)

* Cited by examiner, † Cited by third party
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
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
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101062009A (zh) * 1999-06-07 2007-10-31 莫茨药物股份两合公司 含肉毒神经毒素的治疗剂
AU2005327458A1 (en) * 2005-03-03 2006-10-05 Allergan, Inc. Animal product free system and process 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

Also Published As

Publication number Publication date
CA2997698C (en) 2021-04-20
AU2019201315B2 (en) 2020-10-15
TW201726703A (zh) 2017-08-01
CN108350043A (zh) 2018-07-31
TWI623549B (zh) 2018-05-11
AU2016364597B2 (en) 2019-01-17
MX2018004650A (es) 2018-08-15
BR112018007679A2 (pt) 2018-11-06
US10619143B2 (en) 2020-04-14
RU2707255C1 (ru) 2019-11-25
KR101775682B1 (ko) 2017-09-06
JP6574528B2 (ja) 2019-09-11
WO2017095062A1 (en) 2017-06-08
US20180251741A1 (en) 2018-09-06
AU2019201315A1 (en) 2019-03-21
CA2997698A1 (en) 2017-06-08
KR20170062694A (ko) 2017-06-08
AR107218A1 (es) 2018-04-11
AU2016364597A1 (en) 2018-04-12
EP3383889A1 (en) 2018-10-10
EP3383889A4 (en) 2019-07-17
JP2018533977A (ja) 2018-11-22

Similar Documents

Publication Publication Date Title
CN108350043B (zh) 用于产生肉毒杆菌毒素的方法
KR102485898B1 (ko) 보툴리눔 독소 함유 용액으로부터 보툴리눔 독소를 분리하는 방법
CN104968676A (zh) 一种纯化蛋白质的方法
KR102516204B1 (ko) 보툴리눔 독소의 정제방법
US20240092828A1 (en) Systems and methods for process scale isolation of a protein
CA2559379A1 (en) Process for producing human serum albumin by heating in presence of divalent cation
CN114269773A (zh) 肉毒杆菌毒素的制备方法
CA3124535A1 (en) Botulinum toxin producing method
TWI890364B (zh) 使用多模式層析法純化肉毒毒素的改進方法
JP7680099B2 (ja) 非毒素タンパク質が除去されたクロストリジウム・ボツリヌス神経毒素タンパク質の精製方法
WO2025085544A1 (en) Integrated process for isolation of plasma proteins
CN116802206A (zh) 用于生产规模的免疫球蛋白g分离系统和方法
JP2017025025A (ja) タンパク質の精製方法
CN119790147A (zh) 纯化乙酰肝素-n-硫酸酯酶的新方法
KR20050074806A (ko) 결정형 보툴리늄 독소의 제조방법

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant