AU2010234028B2 - Method for purifying recombinant FSH - Google Patents

Method for purifying recombinant FSH Download PDF

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Publication number
AU2010234028B2
AU2010234028B2 AU2010234028A AU2010234028A AU2010234028B2 AU 2010234028 B2 AU2010234028 B2 AU 2010234028B2 AU 2010234028 A AU2010234028 A AU 2010234028A AU 2010234028 A AU2010234028 A AU 2010234028A AU 2010234028 B2 AU2010234028 B2 AU 2010234028B2
Authority
AU
Australia
Prior art keywords
fsh
chromatography
cys
anion exchange
thr
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.)
Ceased
Application number
AU2010234028A
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English (en)
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AU2010234028A1 (en
Inventor
Stefan Arnold
Dietmar Eichinger
Christian Scheckermann
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.)
Theramex HQ UK Ltd
Original Assignee
Theramex HQ UK 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
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Publication of AU2010234028A1 publication Critical patent/AU2010234028A1/en
Application granted granted Critical
Publication of AU2010234028B2 publication Critical patent/AU2010234028B2/en
Assigned to RATIOPHARM GMBH reassignment RATIOPHARM GMBH Request to Amend Deed and Register Assignors: BIOGENERIX AG
Assigned to Theramex HQ UK Limited reassignment Theramex HQ UK Limited Request for Assignment Assignors: RATIOPHARM GMBH
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • C07K1/02—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
    • 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
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • C12P21/005—Glycopeptides, glycoproteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Reproductive Health (AREA)
  • Zoology (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
AU2010234028A 2009-04-01 2010-04-01 Method for purifying recombinant FSH Ceased AU2010234028B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09157133.1 2009-04-01
EP09157133 2009-04-01
PCT/EP2010/002111 WO2010115586A2 (en) 2009-04-01 2010-04-01 Method for purifying recombinant fsh

Publications (2)

Publication Number Publication Date
AU2010234028A1 AU2010234028A1 (en) 2011-10-27
AU2010234028B2 true AU2010234028B2 (en) 2013-11-14

Family

ID=42153744

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2010234028A Ceased AU2010234028B2 (en) 2009-04-01 2010-04-01 Method for purifying recombinant FSH

Country Status (26)

Country Link
US (3) US9096683B2 (cg-RX-API-DMAC10.html)
EP (1) EP2414380B1 (cg-RX-API-DMAC10.html)
JP (2) JP5845170B2 (cg-RX-API-DMAC10.html)
KR (1) KR101761168B1 (cg-RX-API-DMAC10.html)
CN (1) CN102448979B (cg-RX-API-DMAC10.html)
AU (1) AU2010234028B2 (cg-RX-API-DMAC10.html)
BR (1) BRPI1012647B1 (cg-RX-API-DMAC10.html)
CA (1) CA2755927A1 (cg-RX-API-DMAC10.html)
CY (1) CY1116963T1 (cg-RX-API-DMAC10.html)
DK (1) DK2414380T3 (cg-RX-API-DMAC10.html)
EA (1) EA028065B1 (cg-RX-API-DMAC10.html)
ES (1) ES2552055T3 (cg-RX-API-DMAC10.html)
HR (1) HRP20151086T1 (cg-RX-API-DMAC10.html)
HU (1) HUE025959T2 (cg-RX-API-DMAC10.html)
IL (1) IL215234A (cg-RX-API-DMAC10.html)
ME (1) ME02277B (cg-RX-API-DMAC10.html)
MX (1) MX2011010480A (cg-RX-API-DMAC10.html)
NZ (1) NZ595661A (cg-RX-API-DMAC10.html)
PL (1) PL2414380T3 (cg-RX-API-DMAC10.html)
PT (1) PT2414380E (cg-RX-API-DMAC10.html)
RS (1) RS54318B1 (cg-RX-API-DMAC10.html)
SI (1) SI2414380T1 (cg-RX-API-DMAC10.html)
SM (1) SMT201500276B (cg-RX-API-DMAC10.html)
UA (1) UA106369C2 (cg-RX-API-DMAC10.html)
WO (1) WO2010115586A2 (cg-RX-API-DMAC10.html)
ZA (1) ZA201106800B (cg-RX-API-DMAC10.html)

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JP5845170B2 (ja) * 2009-04-01 2016-01-20 ラティオファーム ゲーエムベーハー 組換えｆｓｈを精製する方法
CN103570820B (zh) * 2012-08-06 2015-11-18 齐鲁制药有限公司 一种重组人促卵泡激素的纯化方法
KR101516054B1 (ko) * 2012-11-21 2015-05-06 씨제이헬스케어 주식회사 신규한 지속형 인간 성장호르몬 단량체를 제조하는 방법
CN103059125B (zh) * 2012-12-27 2015-08-12 浙江海正药业股份有限公司 重组人促卵泡激素的纯化方法
US20160024181A1 (en) 2013-03-13 2016-01-28 Moderna Therapeutics, Inc. Long-lived polynucleotide molecules
CN103539860B (zh) * 2013-11-01 2014-12-03 广州优联康医药科技有限公司 一种长效重组人促卵泡激素融合蛋白
CN103539861B (zh) * 2013-11-01 2015-02-18 广州联康生物科技有限公司 长效重组人促卵泡激素融合蛋白
CA2945591A1 (en) * 2014-04-18 2015-10-22 Cadila Healthcare Limited Novel purification process of gonadotropin
CN104479005B (zh) * 2014-09-05 2017-10-31 上海丽珠制药有限公司 一种促性腺激素纯化的方法
CN105461799A (zh) * 2015-12-31 2016-04-06 哈药集团技术中心 一种重组人促卵泡生成素的纯化方法
CN106117342B (zh) * 2016-07-07 2020-01-03 江西浩然生物医药有限公司 一种高纯度尿促卵泡素的制备方法
RU2694598C1 (ru) * 2018-08-07 2019-07-16 Федеральное государственное бюджетное учреждение науки институт биоорганической химии им. академиков М.М. Шемякина и Ю.А. Овчинникова Российской академии наук (ИБХ РАН) Клеточная линия huFSHKKc6 - продуцент рекомбинантного человеческого фолликулостимулирующего гормона (ФСГ) и способ получения ФСГ с использованием данной линии
KR102752765B1 (ko) * 2019-12-26 2025-01-14 주식회사 엘지화학 여포 자극 호르몬의 정제 방법
KR102283871B1 (ko) * 2021-03-02 2021-08-02 한국원자력연구원 크로마토그래피를 이용한 무담체 홀뮴-166의 분리 방법, 분리 장치 및 이에 의하여 분리된 무담체 홀뮴-166
CN113372433B (zh) * 2021-03-12 2022-10-11 上海景泽生物技术有限公司 纯化fsh方法
CN114591414A (zh) * 2022-03-24 2022-06-07 江西浩然生物制药有限公司 一种人绒毛膜促性腺激素的制备方法

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WO2000063248A2 (en) * 1999-04-16 2000-10-26 Instituto Massone S.A. Highly purified gonadotropin compositions and process for preparing them
US20030059898A1 (en) * 1983-11-02 2003-03-27 Genzyme Corporation Cells, vectors and methods for producing biologically active heterodimeric proteins
WO2005063811A1 (en) * 2003-12-22 2005-07-14 Ares Trading S.A. Method for purifying fsh
WO2006051070A1 (en) * 2004-11-09 2006-05-18 Ares Trading S.A. Method for purifying fsh
WO2007065918A2 (en) * 2005-12-09 2007-06-14 Ares Trading S.A. Method for purifying fsh or a fsh mutant

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US6414123B1 (en) * 1997-10-21 2002-07-02 Vitro Diagnostics, Inc. Method for purifying FSH
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WO2001058493A1 (en) 2000-02-11 2001-08-16 Maxygen Aps Conjugates of follicle stimulating hormones
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WO2004087213A1 (en) 2003-04-02 2004-10-14 Ares Trading S.A. Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant
TW200728316A (en) * 2005-12-09 2007-08-01 Ares Trading Sa Method for purifying FSH or a FSH mutant
CN101720332B (zh) 2007-06-28 2014-08-13 拉蒂奥法姆有限责任公司 生产促卵泡激素的细胞克隆
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US20030059898A1 (en) * 1983-11-02 2003-03-27 Genzyme Corporation Cells, vectors and methods for producing biologically active heterodimeric proteins
WO2000063248A2 (en) * 1999-04-16 2000-10-26 Instituto Massone S.A. Highly purified gonadotropin compositions and process for preparing them
WO2005063811A1 (en) * 2003-12-22 2005-07-14 Ares Trading S.A. Method for purifying fsh
WO2006051070A1 (en) * 2004-11-09 2006-05-18 Ares Trading S.A. Method for purifying fsh
WO2007065918A2 (en) * 2005-12-09 2007-06-14 Ares Trading S.A. Method for purifying fsh or a fsh mutant

Also Published As

Publication number Publication date
MX2011010480A (es) 2012-09-07
EP2414380A2 (en) 2012-02-08
KR20120013359A (ko) 2012-02-14
ES2552055T3 (es) 2015-11-25
EA028065B1 (ru) 2017-10-31
BRPI1012647A2 (pt) 2020-08-11
KR101761168B1 (ko) 2017-07-25
JP6231056B2 (ja) 2017-11-15
HRP20151086T1 (hr) 2015-12-04
IL215234A (en) 2016-09-29
EA201171199A1 (ru) 2012-05-30
UA106369C2 (ru) 2014-08-26
JP2012522736A (ja) 2012-09-27
PT2414380E (pt) 2015-11-13
WO2010115586A3 (en) 2010-11-25
BRPI1012647B1 (pt) 2022-05-17
CY1116963T1 (el) 2017-04-05
RS54318B1 (sr) 2016-02-29
US9096683B2 (en) 2015-08-04
US20150353599A1 (en) 2015-12-10
ME02277B (me) 2016-02-20
SMT201500276B (it) 2016-01-08
EP2414380B1 (en) 2015-08-26
WO2010115586A2 (en) 2010-10-14
AU2010234028A1 (en) 2011-10-27
US20120135928A1 (en) 2012-05-31
CN102448979A (zh) 2012-05-09
NZ595661A (en) 2013-07-26
ZA201106800B (en) 2012-08-28
DK2414380T3 (en) 2015-10-19
CA2755927A1 (en) 2010-10-14
US20160304575A1 (en) 2016-10-20
CN102448979B (zh) 2015-03-04
PL2414380T3 (pl) 2016-01-29
IL215234A0 (en) 2011-12-29
JP2016027050A (ja) 2016-02-18
JP5845170B2 (ja) 2016-01-20
SI2414380T1 (sl) 2015-12-31
HUE025959T2 (en) 2016-05-30

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FGA Letters patent sealed or granted (standard patent)
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Owner name: THERAMEX HQ UK LIMITED

Free format text: FORMER OWNER(S): RATIOPHARM GMBH

MK14 Patent ceased section 143(a) (annual fees not paid) or expired