WO2008117735A1 - 高純度可溶性トロンボモジュリンの製造方法 - Google Patents

高純度可溶性トロンボモジュリンの製造方法 Download PDF

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Publication number
WO2008117735A1
WO2008117735A1 PCT/JP2008/055211 JP2008055211W WO2008117735A1 WO 2008117735 A1 WO2008117735 A1 WO 2008117735A1 JP 2008055211 W JP2008055211 W JP 2008055211W WO 2008117735 A1 WO2008117735 A1 WO 2008117735A1
Authority
WO
WIPO (PCT)
Prior art keywords
soluble thrombomodulin
variant
high purity
substantially contains
producing soluble
Prior art date
Application number
PCT/JP2008/055211
Other languages
English (en)
French (fr)
Inventor
Susumu Ohigashi
Original Assignee
Asahi Kasei Pharma Corporation
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
Priority to KR1020097017230A priority Critical patent/KR101238047B1/ko
Priority to EP08722575.1A priority patent/EP2138505B1/en
Priority to AU2008230465A priority patent/AU2008230465B2/en
Priority to ES08722575.1T priority patent/ES2496596T3/es
Priority to NZ579873A priority patent/NZ579873A/en
Priority to JP2009506314A priority patent/JP5117486B2/ja
Application filed by Asahi Kasei Pharma Corporation filed Critical Asahi Kasei Pharma Corporation
Priority to CA2681294A priority patent/CA2681294C/en
Priority to US12/532,598 priority patent/US8258269B2/en
Priority to CN2008800096257A priority patent/CN101641368B/zh
Publication of WO2008117735A1 publication Critical patent/WO2008117735A1/ja
Priority to HK10104518.3A priority patent/HK1137185A1/xx
Priority to US13/557,645 priority patent/US8952137B2/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/165Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/7455Thrombomodulin
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • C12P21/02Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione

Abstract

 本発明の課題は、酸性下において生成し得る可溶性トロンボモジュリンの変性体を実質的に含有しない可溶性トロンボモジュリンを得るものである。本発明によれば、酸性下において生成し得る可溶性トロンボモジュリンの変性体を含むか、含むことが疑われる可溶性トロンボモジュリン含有物から、該可溶性トロンボモジュリンの変性体を実質的に含まない可溶性トロンボモジュリンを製造する方法であって、該可溶性トロンボモジュリン含有物を、アニオン交換体または、ヒドロキシアパタイトに供する工程、該可溶性トロンボモジュリンの変性体が分離し得る分離条件にてリニア又はステップワイズ、又はリニアとステップワイズを組み合わせた塩濃度のグラジエントを行い、該可溶性トロンボモジュリンの変性体を実質的に含まない可溶性トロンボモジュリンを含有する溶出画分を、予め確認するか、又は溶出画分を確認しながらかにより、取得する工程からなる上記の製造方法が提供される。
PCT/JP2008/055211 2007-03-23 2008-03-21 高純度可溶性トロンボモジュリンの製造方法 WO2008117735A1 (ja)

Priority Applications (11)

Application Number Priority Date Filing Date Title
EP08722575.1A EP2138505B1 (en) 2007-03-23 2008-03-21 Method for producing soluble thrombomodulin of high purity
AU2008230465A AU2008230465B2 (en) 2007-03-23 2008-03-21 Method for producing high-purity soluble thrombomodulin
ES08722575.1T ES2496596T3 (es) 2007-03-23 2008-03-21 Método para producir trombomodulina soluble de gran pureza
NZ579873A NZ579873A (en) 2007-03-23 2008-03-21 Method for producing soluble thrombomodulin of high purity
JP2009506314A JP5117486B2 (ja) 2007-03-23 2008-03-21 高純度可溶性トロンボモジュリンの製造方法
KR1020097017230A KR101238047B1 (ko) 2007-03-23 2008-03-21 고순도 가용성 트롬보모듈린의 제조방법
CA2681294A CA2681294C (en) 2007-03-23 2008-03-21 Method for producing high-purity soluble thrombomodulin
US12/532,598 US8258269B2 (en) 2007-03-23 2008-03-21 Method for producing high-purity soluble thrombomodulin
CN2008800096257A CN101641368B (zh) 2007-03-23 2008-03-21 高纯度可溶性血栓调节蛋白的制造方法
HK10104518.3A HK1137185A1 (en) 2007-03-23 2010-05-10 Method for producing soluble thrombomodulin of high purity
US13/557,645 US8952137B2 (en) 2007-03-23 2012-07-25 Method for producing high-purity soluble thrombomodulin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007077389 2007-03-23
JP2007-077389 2007-03-23

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/532,598 A-371-Of-International US8258269B2 (en) 2007-03-23 2008-03-21 Method for producing high-purity soluble thrombomodulin
US13/557,645 Division US8952137B2 (en) 2007-03-23 2012-07-25 Method for producing high-purity soluble thrombomodulin

Publications (1)

Publication Number Publication Date
WO2008117735A1 true WO2008117735A1 (ja) 2008-10-02

Family

ID=39788470

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/055211 WO2008117735A1 (ja) 2007-03-23 2008-03-21 高純度可溶性トロンボモジュリンの製造方法

Country Status (13)

Country Link
US (2) US8258269B2 (ja)
EP (1) EP2138505B1 (ja)
JP (1) JP5117486B2 (ja)
KR (1) KR101238047B1 (ja)
CN (1) CN101641368B (ja)
AU (1) AU2008230465B2 (ja)
CA (1) CA2681294C (ja)
ES (1) ES2496596T3 (ja)
HK (1) HK1137185A1 (ja)
NZ (1) NZ579873A (ja)
SG (1) SG184699A1 (ja)
TW (2) TWI461434B (ja)
WO (1) WO2008117735A1 (ja)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011136313A1 (ja) 2010-04-30 2011-11-03 旭化成ファーマ株式会社 高純度可溶性トロンボモジュリン及びその製造方法
US20120238727A1 (en) * 2011-03-14 2012-09-20 Catalent Pharma Solutions Llc Decorin compositions and use thereof
JP2013517284A (ja) * 2010-01-15 2013-05-16 バイオ−ラッド ラボラトリーズ インコーポレーティッド アパタイトの表面中和方法

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US8895707B2 (en) 2010-08-18 2014-11-25 Bio-Rad Laboratories, Inc. Elution of proteins from hydroxyapatite resins without resin deterioration
CA2825651C (en) 2011-02-02 2020-03-24 Bio-Rad Laboratories, Inc. Apatite surface neutralization with alkali solutions
KR101672108B1 (ko) 2011-11-15 2016-11-02 아사히 가세이 파마 가부시키가이샤 패혈증의 치료 및/또는 개선을 위한 의약
WO2013180933A1 (en) 2012-05-30 2013-12-05 Bio-Rad Laboratories, Inc. In situ restoration of apatite-based chromatography resins
US9802822B2 (en) 2014-06-23 2017-10-31 Bio-Rad Laboratories, Inc. Apatite pretreatment
WO2015200299A2 (en) 2014-06-23 2015-12-30 Bio-Rad Laboratories, Inc. Apatite in-situ restoration

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013517284A (ja) * 2010-01-15 2013-05-16 バイオ−ラッド ラボラトリーズ インコーポレーティッド アパタイトの表面中和方法
US9914749B2 (en) 2010-01-15 2018-03-13 Bio-Rad Laboratories, Inc. Surface neutralization of apatite
US10676502B2 (en) 2010-01-15 2020-06-09 Bio-Rad Laboratories, Inc. Surface neutralization of apatite
WO2011136313A1 (ja) 2010-04-30 2011-11-03 旭化成ファーマ株式会社 高純度可溶性トロンボモジュリン及びその製造方法
US20130143790A1 (en) * 2010-04-30 2013-06-06 Asahi Kasei Pharma Corporation Highly-purified soluble thrombomodulin and method for producing same
AU2011246021B2 (en) * 2010-04-30 2014-03-13 Asahi Kasei Pharma Corporation High-purity soluble thrombomodulin and method for producing same
JP2015071646A (ja) * 2010-04-30 2015-04-16 旭化成ファーマ株式会社 高純度可溶性トロンボモジュリン
JP5722314B2 (ja) * 2010-04-30 2015-05-20 旭化成ファーマ株式会社 高純度可溶性トロンボモジュリン及びその製造方法
US9127089B2 (en) 2010-04-30 2015-09-08 Asahi Kasei Pharma Corporation Highly-purified soluble thrombomodulin and method for producing same
EP3150628A1 (en) 2010-04-30 2017-04-05 Asahi Kasei Pharma Corporation Highly-purified soluble thrombomodulin
US20120238727A1 (en) * 2011-03-14 2012-09-20 Catalent Pharma Solutions Llc Decorin compositions and use thereof
US20220073579A1 (en) * 2011-03-14 2022-03-10 Catalent Pharma Solutions Llc Decorin compositions and use thereof

Also Published As

Publication number Publication date
TW200906848A (en) 2009-02-16
CA2681294A1 (en) 2008-10-02
ES2496596T3 (es) 2014-09-19
KR101238047B1 (ko) 2013-02-27
HK1137185A1 (en) 2010-07-23
AU2008230465B2 (en) 2011-10-13
EP2138505B1 (en) 2014-08-06
US8258269B2 (en) 2012-09-04
JPWO2008117735A1 (ja) 2010-07-15
EP2138505A4 (en) 2011-02-09
SG184699A1 (en) 2012-10-30
TW201431872A (zh) 2014-08-16
CN101641368B (zh) 2013-05-08
CA2681294C (en) 2014-05-06
US20130237693A1 (en) 2013-09-12
AU2008230465A1 (en) 2008-10-02
KR20090112709A (ko) 2009-10-28
NZ579873A (en) 2011-11-25
JP5117486B2 (ja) 2013-01-16
US8952137B2 (en) 2015-02-10
US20100145020A1 (en) 2010-06-10
CN101641368A (zh) 2010-02-03
TWI461434B (zh) 2014-11-21
EP2138505A1 (en) 2009-12-30

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