BRPI1012647B1 - Método para purificar um hormônio folículo-estimulante recombinante ou uma variante de hormônio folículo-estimulante recombinante - Google Patents

Método para purificar um hormônio folículo-estimulante recombinante ou uma variante de hormônio folículo-estimulante recombinante Download PDF

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Publication number
BRPI1012647B1
BRPI1012647B1 BRPI1012647-3A BRPI1012647A BRPI1012647B1 BR PI1012647 B1 BRPI1012647 B1 BR PI1012647B1 BR PI1012647 A BRPI1012647 A BR PI1012647A BR PI1012647 B1 BRPI1012647 B1 BR PI1012647B1
Authority
BR
Brazil
Prior art keywords
chromatography
fsh
anion exchange
exchange chromatography
recombinant
Prior art date
Application number
BRPI1012647-3A
Other languages
English (en)
Portuguese (pt)
Inventor
Christian Scheckermann
Dietmar Eichinger
Stefan Arnold
Original Assignee
Theramex HQ UK Limited
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 Limited filed Critical Theramex HQ UK Limited
Publication of BRPI1012647A2 publication Critical patent/BRPI1012647A2/pt
Publication of BRPI1012647B1 publication Critical patent/BRPI1012647B1/pt

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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
    • C07K1/18Ion-exchange 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
    • C07K14/575Hormones
    • C07K14/59Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • C07K1/02General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
    • 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
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • 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
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • 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
    • C12P21/005Glycopeptides, glycoproteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (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)
BRPI1012647-3A 2009-04-01 2010-04-01 Método para purificar um hormônio folículo-estimulante recombinante ou uma variante de hormônio folículo-estimulante recombinante BRPI1012647B1 (pt)

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
BRPI1012647A2 BRPI1012647A2 (pt) 2020-08-11
BRPI1012647B1 true BRPI1012647B1 (pt) 2022-05-17

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI1012647-3A BRPI1012647B1 (pt) 2009-04-01 2010-04-01 Método para purificar um hormônio folículo-estimulante recombinante ou uma variante de hormônio folículo-estimulante recombinante

Country Status (26)

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

Families Citing this family (16)

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KR101761168B1 (ko) * 2009-04-01 2017-07-25 바이오제너릭스 게엠베하 재조합 fsh 정제 방법
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
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
KR102752764B1 (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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US6455282B1 (en) * 1983-11-02 2002-09-24 Genzyme Corporation Cells, vectors and methods for producing biologically active TSH
US4840896A (en) 1983-11-02 1989-06-20 Integrated Genetics, Inc. Heteropolymeric protein
US4923805A (en) 1983-11-02 1990-05-08 Integrated Genetics, Inc. Fsh
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
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US6261823B1 (en) * 1996-12-13 2001-07-17 Schering Corporation Methods for purifying viruses
BR9810478A (pt) 1997-06-25 2000-09-12 Applied Research Systems Análogos de hormÈnio glicoproteìna reticulados por dissulfeto e sua preparação e utilização
US6414123B1 (en) * 1997-10-21 2002-07-02 Vitro Diagnostics, Inc. Method for purifying FSH
US5990288A (en) * 1997-10-21 1999-11-23 Vitro Diagnostics, Inc. Method for purifying FSH
JP4574865B2 (ja) * 1999-04-16 2010-11-04 インスチチュート マッソーネ エス.エイ. 高度に精製されたゴナドトロピン組成物およびそれらの製造方法
AU2001231531A1 (en) 2000-02-11 2001-08-20 Maxygen Aps Follicle stimulating hormones
US7157277B2 (en) * 2001-11-28 2007-01-02 Neose Technologies, Inc. Factor VIII remodeling and glycoconjugation of Factor VIII
WO2003103070A2 (en) 2002-05-31 2003-12-11 E. I. Du Pont De Nemours And Company Copolymers having tunable energy levels and color of emission
AU2004226666B9 (en) 2003-04-02 2010-04-08 Ares Trading S.A. Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
AU2004309040B2 (en) 2003-12-22 2010-12-16 Ares Trading S.A. Method for purifying FSH
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KR101761168B1 (ko) * 2009-04-01 2017-07-25 바이오제너릭스 게엠베하 재조합 fsh 정제 방법

Also Published As

Publication number Publication date
MX2011010480A (es) 2012-09-07
US20150353599A1 (en) 2015-12-10
PT2414380E (pt) 2015-11-13
UA106369C2 (ru) 2014-08-26
PL2414380T3 (pl) 2016-01-29
IL215234A (en) 2016-09-29
KR101761168B1 (ko) 2017-07-25
US9096683B2 (en) 2015-08-04
WO2010115586A2 (en) 2010-10-14
EA028065B1 (ru) 2017-10-31
NZ595661A (en) 2013-07-26
CN102448979B (zh) 2015-03-04
HRP20151086T1 (hr) 2015-12-04
JP2012522736A (ja) 2012-09-27
US20160304575A1 (en) 2016-10-20
HUE025959T2 (en) 2016-05-30
EP2414380A2 (en) 2012-02-08
SMT201500276B (it) 2016-01-08
EA201171199A1 (ru) 2012-05-30
ZA201106800B (en) 2012-08-28
CA2755927A1 (en) 2010-10-14
JP5845170B2 (ja) 2016-01-20
CN102448979A (zh) 2012-05-09
AU2010234028A1 (en) 2011-10-27
BRPI1012647A2 (pt) 2020-08-11
JP2016027050A (ja) 2016-02-18
CY1116963T1 (el) 2017-04-05
JP6231056B2 (ja) 2017-11-15
WO2010115586A3 (en) 2010-11-25
RS54318B1 (sr) 2016-02-29
IL215234A0 (en) 2011-12-29
ES2552055T3 (es) 2015-11-25
ME02277B (me) 2016-02-20
KR20120013359A (ko) 2012-02-14
EP2414380B1 (en) 2015-08-26
SI2414380T1 (sl) 2015-12-31
AU2010234028B2 (en) 2013-11-14
DK2414380T3 (en) 2015-10-19
US20120135928A1 (en) 2012-05-31

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Legal Events

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B25D Requested change of name of applicant approved

Owner name: BIOGENERIX GMBH (DE)

B25A Requested transfer of rights approved

Owner name: RATIOPHARM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: THERAMEX HQ UK LIMITED (GB)

B25G Requested change of headquarter approved

Owner name: THERAMEX HQ UK LIMITED (GB)

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/04/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 13A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2716 DE 24-01-2023 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.