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)
Other versions
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
Application filed by Theramex HQ UK Ltd filed Critical Theramex HQ UK Ltd
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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (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 2009-04-01
EP09157133.1 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 (https=)
EP (1) EP2414380B1 (https=)
JP (2) JP5845170B2 (https=)
KR (1) KR101761168B1 (https=)
CN (1) CN102448979B (https=)
AU (1) AU2010234028B2 (https=)
BR (1) BRPI1012647B1 (https=)
CA (1) CA2755927A1 (https=)
CY (1) CY1116963T1 (https=)
DK (1) DK2414380T3 (https=)
EA (1) EA028065B1 (https=)
ES (1) ES2552055T3 (https=)
HR (1) HRP20151086T1 (https=)
HU (1) HUE025959T2 (https=)
IL (1) IL215234A (https=)
ME (1) ME02277B (https=)
MX (1) MX2011010480A (https=)
NZ (1) NZ595661A (https=)
PL (1) PL2414380T3 (https=)
PT (1) PT2414380E (https=)
RS (1) RS54318B1 (https=)
SI (1) SI2414380T1 (https=)
SM (1) SMT201500276B (https=)
UA (1) UA106369C2 (https=)
WO (1) WO2010115586A2 (https=)
ZA (1) ZA201106800B (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EP2968391A1 (en) 2013-03-13 2016-01-20 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
KR20160131113A (ko) * 2014-04-18 2016-11-15 카딜라 핼쓰캐어 리미티드 고나도트로핀의 신규한 정제 방법
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
CN114867741A (zh) * 2019-12-26 2022-08-05 株式会社Lg化学 纯化促卵泡激素的方法
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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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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US4923805A (en) 1983-11-02 1990-05-08 Integrated Genetics, Inc. Fsh
US4840896A (en) 1983-11-02 1989-06-20 Integrated Genetics, Inc. Heteropolymeric protein
IT1206302B (it) 1987-06-26 1989-04-14 Serono Cesare Ist Ricerca Ormone follicolo-stimolante urinario
CA2018676C (en) 1989-06-20 2003-05-06 Christie A. Kelton Novel heteropolymeric protein production methods
US5021160A (en) * 1990-01-09 1991-06-04 Gelman Sciences, Inc. Strongly acidic microporous membranes for cation exchange
DE4440587A1 (de) 1994-11-14 1996-05-15 Fliether Karl Gmbh & Co Basquill-Schloß
US6261823B1 (en) * 1996-12-13 2001-07-17 Schering Corporation Methods for purifying viruses
ES2332931T3 (es) 1997-06-25 2010-02-15 Merck Serono Sa Analogos de hormonas glicoproteinicas entrelazadas por disulfuro, su preparacion y uso.
US5990288A (en) * 1997-10-21 1999-11-23 Vitro Diagnostics, Inc. Method for purifying FSH
US6414123B1 (en) * 1997-10-21 2002-07-02 Vitro Diagnostics, Inc. Method for purifying FSH
WO2001058493A1 (en) 2000-02-11 2001-08-16 Maxygen Aps Conjugates of follicle stimulating hormones
US7157277B2 (en) * 2001-11-28 2007-01-02 Neose Technologies, Inc. Factor VIII remodeling and glycoconjugation of Factor VIII
CA2483650A1 (en) 2002-05-31 2003-12-11 E.I. Du Pont De Nemours And Company Copolymers having tunable energy levels and color of emission
DK1610822T4 (en) 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
ES2572629T3 (es) * 2005-12-09 2016-06-01 Ares Trading S.A. Método para purificar FSH o un mutante de FSH
DK2170942T3 (da) * 2007-06-28 2013-11-04 Biogenerix Ag Fsh-producerende celleklon
AR067536A1 (es) * 2007-07-17 2009-10-14 Hoffmann La Roche Metodo para obtener una eritropoyetina mono-pegilada en una forma sustancialmente homogenea
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

Patent Citations (5)

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

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FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

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