CY1116963T1 - Μεθοδος για καθαρισμο ανασυνδυασμενης fsh - Google Patents

Μεθοδος για καθαρισμο ανασυνδυασμενης fsh

Info

Publication number
CY1116963T1
CY1116963T1 CY20151100971T CY151100971T CY1116963T1 CY 1116963 T1 CY1116963 T1 CY 1116963T1 CY 20151100971 T CY20151100971 T CY 20151100971T CY 151100971 T CY151100971 T CY 151100971T CY 1116963 T1 CY1116963 T1 CY 1116963T1
Authority
CY
Cyprus
Prior art keywords
fsh
recombinant
chromatography
variant
anion exchange
Prior art date
Application number
CY20151100971T
Other languages
English (en)
Inventor
Christian Scheckermann
Dietmar Eichinger
Stefan Arnold
Original Assignee
Ratiopharm Gmbh
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 Ratiopharm Gmbh filed Critical Ratiopharm Gmbh
Publication of CY1116963T1 publication Critical patent/CY1116963T1/el

Links

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
    • 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]
    • 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
    • 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)
  • Genetics & Genomics (AREA)
  • Molecular Biology (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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Biotechnology (AREA)
  • Microbiology (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)

Abstract

Η παρούσα εφεύρεση σχετίζεται με μία μέθοδο για καθαρισμό μιας ανασυνδυασμένης ωοθυλακιοτρόπου ορμόνης (FSH) ή παραλλαγής ανασυνδυασμένης FSH. Η μέθοδος περιλαμβάνει τα στάδια της υποβολής ενός υγρού το οποίο περιέχει μια ανασυνδυασμένη FSH ή παραλλαγή ανασυνδυασμένης FSH σε μια ανιονανταλλακτική χρωματογραφία, σε μια χρωματογραφία υδρόφοβων αλληλεπιδράσεων, και μια χρωματογραφία συγγένειας χρωστικής, όπου αυτές οι χρωματογραφίες μπορεί να πραγματοποιηθούν σε οποιαδήποτε σειρά, και όπου η μέθοδος δεν περιλαμβάνει ούτε μία ασθενή ανιονανταλλακτική χρωματογραφία ούτε μία χρωματογραφία αντίστροφης φάσης. Η μέθοδος καθαρισμού έχει ως αποτέλεσμα μια υψηλή απόδοση ανασυνδυασμένης FSH η οποία έχει έναν επιθυμητό βαθμό καθαρότητας. Η ληφθείσα FSH είναι ιδιαίτερα χρήσιμη για την προφύλαξη και αντιμετώπιση διαταραχών και ιατρικών ενδείξεων όπου FSH παρασκευάσματα θεωρούνται ως χρήσιμα φάρμακα.
CY20151100971T 2009-04-01 2015-10-30 Μεθοδος για καθαρισμο ανασυνδυασμενης fsh CY1116963T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09157133 2009-04-01
EP10713424.9A EP2414380B1 (en) 2009-04-01 2010-04-01 Method for purifying recombinant fsh

Publications (1)

Publication Number Publication Date
CY1116963T1 true CY1116963T1 (el) 2017-04-05

Family

ID=42153744

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20151100971T CY1116963T1 (el) 2009-04-01 2015-10-30 Μεθοδος για καθαρισμο ανασυνδυασμενης fsh

Country Status (26)

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

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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
SG11201608513WA (en) * 2014-04-18 2016-11-29 Cadila Healthcare Ltd 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
WO2021132958A1 (ko) * 2019-12-26 2021-07-01 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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Also Published As

Publication number Publication date
BRPI1012647B1 (pt) 2022-05-17
EP2414380A2 (en) 2012-02-08
HRP20151086T1 (hr) 2015-12-04
SMT201500276B (it) 2016-01-08
US20120135928A1 (en) 2012-05-31
IL215234A0 (en) 2011-12-29
JP2016027050A (ja) 2016-02-18
IL215234A (en) 2016-09-29
CA2755927A1 (en) 2010-10-14
EA201171199A1 (ru) 2012-05-30
JP5845170B2 (ja) 2016-01-20
AU2010234028A1 (en) 2011-10-27
WO2010115586A3 (en) 2010-11-25
RS54318B1 (en) 2016-02-29
SI2414380T1 (sl) 2015-12-31
WO2010115586A2 (en) 2010-10-14
DK2414380T3 (en) 2015-10-19
JP2012522736A (ja) 2012-09-27
HUE025959T2 (en) 2016-05-30
EA028065B1 (ru) 2017-10-31
BRPI1012647A2 (pt) 2020-08-11
KR101761168B1 (ko) 2017-07-25
CN102448979A (zh) 2012-05-09
CN102448979B (zh) 2015-03-04
MX2011010480A (es) 2012-09-07
ES2552055T3 (es) 2015-11-25
NZ595661A (en) 2013-07-26
AU2010234028B2 (en) 2013-11-14
US20160304575A1 (en) 2016-10-20
ME02277B (me) 2016-02-20
US20150353599A1 (en) 2015-12-10
PL2414380T3 (pl) 2016-01-29
PT2414380E (pt) 2015-11-13
JP6231056B2 (ja) 2017-11-15
US9096683B2 (en) 2015-08-04
EP2414380B1 (en) 2015-08-26
UA106369C2 (ru) 2014-08-26
KR20120013359A (ko) 2012-02-14
ZA201106800B (en) 2012-08-28

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