HRP20161520T1 - Rekombinantni fsh uključujući alfa 2,3- i alfa 2,6-sialilaciju - Google Patents
Rekombinantni fsh uključujući alfa 2,3- i alfa 2,6-sialilaciju Download PDFInfo
- Publication number
- HRP20161520T1 HRP20161520T1 HRP20161520TT HRP20161520T HRP20161520T1 HR P20161520 T1 HRP20161520 T1 HR P20161520T1 HR P20161520T T HRP20161520T T HR P20161520TT HR P20161520 T HRP20161520 T HR P20161520T HR P20161520 T1 HRP20161520 T1 HR P20161520T1
- Authority
- HR
- Croatia
- Prior art keywords
- sialylation
- alpha
- recombinant fsh
- rfsh
- cell line
- Prior art date
Links
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 230000009450 sialylation Effects 0.000 claims 3
- 210000005260 human cell Anatomy 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 210000004027 cell Anatomy 0.000 claims 1
- 208000000509 infertility Diseases 0.000 claims 1
- 230000036512 infertility Effects 0.000 claims 1
- 231100000535 infertility Toxicity 0.000 claims 1
Classifications
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- 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]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y204/00—Glycosyltransferases (2.4)
- C12Y204/99—Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y204/00—Glycosyltransferases (2.4)
- C12Y204/99—Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
- C12Y204/99006—N-Acetyllactosaminide alpha-2,3-sialyltransferase (2.4.99.6)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Endocrinology (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Reproductive Health (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Toxicology (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Physics & Mathematics (AREA)
- Plant Pathology (AREA)
- Microbiology (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)
Claims (7)
1. Rekombinantni FSH (rFSH) uključujući α2,3- i a2,6-sialilaciju naznačen time da je 80% ili više od ukupne sialilacije α2,3-sialilacija i pri čemu od 5% do 20% od ukupne sialilacije je α2,6-sialilacija.
2. Rekombinantni FSH prema zahtjevu 1 naznačen time da je eksprimiran u ljudskoj staničnoj liniji.
3. Farmaceutski pripravak naznačen time da sadrži rFSH prema zahtjevu 1 ili zahtjevu 2.
4. Farmaceutski pripravak prema zahtjevu 3 naznačen time da dodatno sadrži hCG i/ili LH.
5. Farmaceutski pripravak prema zahtjevu 3 ili 4 naznačen time da je za uporabu za liječenje neplodnosti.
6. Postupak proizvodnje rFSH prema bilo kojem od zahtjeva 1 ili 2 naznačen time da sadrži korak proizvodnje ili eksprimiranja rFSH u ljudskoj staničnoj liniji.
7. Postupak prema zahtjevu 6 naznačen time da je stanična linija izmijenjena upotrebom α2,3-sialiltransferaze i/ili α2,6-sialiltransferaze.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4542408P | 2008-04-16 | 2008-04-16 | |
EP08251528 | 2008-04-25 | ||
EP14178729.1A EP2808340B1 (en) | 2008-04-16 | 2009-04-16 | Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20161520T1 true HRP20161520T1 (hr) | 2016-12-30 |
Family
ID=39717519
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20140535AT HRP20140535T1 (hr) | 2008-04-16 | 2014-06-09 | Rekombinantni fsh ukljuäśujuä†i alfa 2,3- i alfa 2,6-sialilaciju |
HRP20161520TT HRP20161520T1 (hr) | 2008-04-16 | 2016-11-16 | Rekombinantni fsh uključujući alfa 2,3- i alfa 2,6-sialilaciju |
HRP20170958TT HRP20170958T1 (hr) | 2008-04-16 | 2017-06-26 | Rekombinantni fsh uključujući alfa 2,3- i alfa 2,6- sialilaciju |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20140535AT HRP20140535T1 (hr) | 2008-04-16 | 2014-06-09 | Rekombinantni fsh ukljuäśujuä†i alfa 2,3- i alfa 2,6-sialilaciju |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20170958TT HRP20170958T1 (hr) | 2008-04-16 | 2017-06-26 | Rekombinantni fsh uključujući alfa 2,3- i alfa 2,6- sialilaciju |
Country Status (29)
Country | Link |
---|---|
US (5) | US8951967B2 (hr) |
EP (7) | EP3098234A1 (hr) |
JP (7) | JP2011519359A (hr) |
KR (5) | KR20160056960A (hr) |
CN (3) | CN105906703A (hr) |
AR (1) | AR071479A1 (hr) |
AU (5) | AU2009237479B2 (hr) |
BR (1) | BRPI0910461B8 (hr) |
CA (1) | CA2725257A1 (hr) |
CY (1) | CY1115413T1 (hr) |
DK (4) | DK2808340T3 (hr) |
ES (3) | ES2468318T3 (hr) |
FR (1) | FR17C1020I2 (hr) |
HK (2) | HK1146284A1 (hr) |
HR (3) | HRP20140535T1 (hr) |
HU (5) | HUE033830T2 (hr) |
IL (2) | IL208538A (hr) |
LT (4) | LT2808340T (hr) |
MX (3) | MX2010011343A (hr) |
NO (2) | NO2017025I1 (hr) |
NZ (1) | NZ588381A (hr) |
PL (4) | PL2268666T3 (hr) |
PT (4) | PT3144318T (hr) |
RU (3) | RU2682270C2 (hr) |
SA (1) | SA109300228B1 (hr) |
SI (4) | SI2808340T1 (hr) |
TW (1) | TWI488640B (hr) |
WO (1) | WO2009127826A1 (hr) |
ZA (1) | ZA201007373B (hr) |
Families Citing this family (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
TWI532495B (zh) | 2009-10-05 | 2016-05-11 | 菲瑞茵國際中心股份有限公司 | 藥學製劑 |
EP2417982A1 (en) | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilization of gonadotropins |
WO2012016576A1 (en) * | 2010-08-04 | 2012-02-09 | Glycotope Gmbh | Improved recombinant human follicle-stimulating hormone |
WO2012042381A1 (en) | 2010-09-29 | 2012-04-05 | Ferring B.V. | Composition for controlled ovarian stimulation |
JP5918697B2 (ja) | 2010-10-15 | 2016-05-18 | Jcrファーマ株式会社 | 糖鎖の非還元末端がマンノース残基である糖蛋白質の製造方法 |
CA2831486A1 (en) | 2011-03-31 | 2012-10-04 | Ferring B.V. | Pharmaceutical preparation |
EP2717904A1 (en) | 2011-06-06 | 2014-04-16 | Ferring BV | Pharmaceutical preparation comprising recombinant fsh |
JO3092B1 (ar) | 2011-08-08 | 2017-03-15 | Ferring Bv | مركب لتحفيز مسيطر عليه للمبيض |
AU2012340501A1 (en) * | 2011-12-19 | 2013-07-11 | Grifols, S.A. | Compositions, methods, and kits for preparing sialylated recombinant proteins |
EP2848687B1 (en) * | 2012-04-27 | 2017-09-13 | JCR Pharmaceuticals Co., Ltd. | Novel expression vector |
EP2824176A1 (en) | 2013-07-11 | 2015-01-14 | Siamed'xpress | Methods for producing sialylated therapeutic proteins |
JP6652334B2 (ja) * | 2014-05-31 | 2020-02-19 | Jcrファーマ株式会社 | ウリジンとn−アセチル−d−マンノサミンとを含有する培地 |
EP3237608B1 (en) * | 2014-12-22 | 2019-10-09 | F. Hoffmann-La Roche AG | Cmp-dependent sialidase activity |
JP7079094B2 (ja) | 2015-04-17 | 2022-06-01 | フェリング ベスローテン フェンノートシャップ | 不妊症の処置のための組成物 |
WO2016207353A1 (en) * | 2015-06-26 | 2016-12-29 | Ferring B.V. | Methods of purification and/or viral inactivation |
EP3205719A1 (en) * | 2016-02-15 | 2017-08-16 | CEVEC Pharmaceuticals GmbH | Cell lines for producing recombinant glycoproteins with di-antennary n-glycans, methods using the same, and recombinant glycoproteins |
GB201603280D0 (en) | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
EP3382014A1 (en) * | 2017-03-29 | 2018-10-03 | CEVEC Pharmaceuticals GmbH | Recombinant glycoproteins with reduced antennary fucosylation |
ES2904787T3 (es) | 2017-09-01 | 2022-04-06 | Ferring Bv | Composición para la estimulación ovárica controlada |
US20210038694A1 (en) | 2018-04-30 | 2021-02-11 | Ferring B.V. | Composition for controlled ovarian stimulation |
KR20210079276A (ko) | 2018-10-17 | 2021-06-29 | 훼링 비.브이. | 제어된 난소 자극을 위한 조성물 및 방법 |
WO2021081670A1 (en) * | 2019-11-01 | 2021-05-06 | The University Of British Columbia | Compositions and methods for sialylated mucin-type o-glycosylation of therapeutic proteins |
TW202237173A (zh) | 2020-12-09 | 2022-10-01 | 荷蘭商菲林公司 | 用於受控的卵巢刺激之組成物及方法 |
WO2023186331A1 (en) | 2022-04-01 | 2023-10-05 | Ferring B.V. | Mixed protocol for treatment of infertility |
WO2023227761A1 (en) | 2022-05-26 | 2023-11-30 | Ferring B.V. | Compositions and methods for treatment of infertility in males |
WO2024008971A1 (en) | 2022-07-08 | 2024-01-11 | Ferring B.V. | Compositions and methods for intrauterine insemination (iui) |
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TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
TWI532495B (zh) * | 2009-10-05 | 2016-05-11 | 菲瑞茵國際中心股份有限公司 | 藥學製劑 |
EP2417982A1 (en) | 2010-07-30 | 2012-02-15 | Ferring B.V. | Stabilization of gonadotropins |
US8790322B2 (en) | 2010-08-03 | 2014-07-29 | King Saud University | Stoma coat |
WO2012016576A1 (en) | 2010-08-04 | 2012-02-09 | Glycotope Gmbh | Improved recombinant human follicle-stimulating hormone |
WO2012042381A1 (en) | 2010-09-29 | 2012-04-05 | Ferring B.V. | Composition for controlled ovarian stimulation |
CA2831486A1 (en) | 2011-03-31 | 2012-10-04 | Ferring B.V. | Pharmaceutical preparation |
EP2717904A1 (en) | 2011-06-06 | 2014-04-16 | Ferring BV | Pharmaceutical preparation comprising recombinant fsh |
JO3092B1 (ar) | 2011-08-08 | 2017-03-15 | Ferring Bv | مركب لتحفيز مسيطر عليه للمبيض |
BR112016023668A2 (pt) | 2014-04-18 | 2017-10-17 | Glycotope Gmbh | hiperestimulação ovariana controlada com hormônio de estimulação de folículo humano recombinante aperfeiçoado |
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2009
- 2009-04-15 TW TW098112483A patent/TWI488640B/zh active
- 2009-04-16 PL PL09733497T patent/PL2268666T3/pl unknown
- 2009-04-16 BR BRPI0910461A patent/BRPI0910461B8/pt active IP Right Grant
- 2009-04-16 ES ES09733497.3T patent/ES2468318T3/es active Active
- 2009-04-16 KR KR1020167012148A patent/KR20160056960A/ko not_active Application Discontinuation
- 2009-04-16 EP EP16179121.5A patent/EP3098234A1/en active Pending
- 2009-04-16 PT PT161949250T patent/PT3144318T/pt unknown
- 2009-04-16 EP EP14178729.1A patent/EP2808340B1/en not_active Revoked
- 2009-04-16 PT PT161581418T patent/PT3045471T/pt unknown
- 2009-04-16 AU AU2009237479A patent/AU2009237479B2/en active Active
- 2009-04-16 HU HUE16158141A patent/HUE033830T2/en unknown
- 2009-04-16 EP EP13193214.7A patent/EP2722339A1/en active Pending
- 2009-04-16 KR KR1020107025581A patent/KR101622944B1/ko active IP Right Grant
- 2009-04-16 PT PT97334973T patent/PT2268666E/pt unknown
- 2009-04-16 KR KR1020187023820A patent/KR20180095140A/ko active Application Filing
- 2009-04-16 JP JP2011504527A patent/JP2011519359A/ja active Pending
- 2009-04-16 RU RU2014141994A patent/RU2682270C2/ru active
- 2009-04-16 SI SI200931547A patent/SI2808340T1/sl unknown
- 2009-04-16 HU HUE14178729A patent/HUE030652T4/en unknown
- 2009-04-16 PL PL16158141T patent/PL3045471T3/pl unknown
- 2009-04-16 CN CN201510933827.2A patent/CN105906703A/zh active Pending
- 2009-04-16 RU RU2010141908/10A patent/RU2537268C2/ru active
- 2009-04-16 PL PL16194925T patent/PL3144318T3/pl unknown
- 2009-04-16 CN CN201510933782.9A patent/CN105906702A/zh active Pending
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- 2009-04-16 EP EP09733497.3A patent/EP2268666B1/en not_active Revoked
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- 2009-04-16 CA CA2725257A patent/CA2725257A1/en active Pending
- 2009-04-16 MX MX2010011343A patent/MX2010011343A/es active IP Right Grant
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- 2009-04-16 WO PCT/GB2009/000978 patent/WO2009127826A1/en active Application Filing
- 2009-04-16 ES ES16158141.8T patent/ES2629392T3/es active Active
- 2009-04-16 DK DK14178729.1T patent/DK2808340T3/en active
- 2009-04-16 US US12/988,218 patent/US8951967B2/en active Active
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- 2009-04-16 CN CN200980121391XA patent/CN102066414A/zh active Pending
- 2009-04-16 KR KR1020177026920A patent/KR20170110741A/ko not_active Application Discontinuation
- 2009-04-16 DK DK09733497.3T patent/DK2268666T3/da active
- 2009-04-16 DK DK16194925.0T patent/DK3144318T3/da active
- 2009-04-16 DK DK16158141.8T patent/DK3045471T3/en active
- 2009-04-16 LT LTEP16158141.8T patent/LT3045471T/lt unknown
- 2009-04-16 AR ARP090101333A patent/AR071479A1/es not_active Application Discontinuation
- 2009-04-16 MX MX2014011348A patent/MX348622B/es unknown
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- 2009-04-16 EP EP16158141.8A patent/EP3045471B1/en not_active Revoked
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