SA109300228B1 - تحضير صيدلاني من FSH مأشوب (rFSH) وعملية واستخدام التحضير الصيدلاني - Google Patents
تحضير صيدلاني من FSH مأشوب (rFSH) وعملية واستخدام التحضير الصيدلاني Download PDFInfo
- Publication number
- SA109300228B1 SA109300228B1 SA109300228A SA109300228A SA109300228B1 SA 109300228 B1 SA109300228 B1 SA 109300228B1 SA 109300228 A SA109300228 A SA 109300228A SA 109300228 A SA109300228 A SA 109300228A SA 109300228 B1 SA109300228 B1 SA 109300228B1
- Authority
- SA
- Saudi Arabia
- Prior art keywords
- fsh
- sialic acid
- mol
- sialylation
- recombinant
- Prior art date
Links
- 238000000034 method Methods 0.000 title description 24
- 239000000825 pharmaceutical preparation Substances 0.000 title description 5
- 230000008569 process Effects 0.000 title description 4
- 102000012673 Follicle Stimulating Hormone Human genes 0.000 claims description 167
- 108010079345 Follicle Stimulating Hormone Proteins 0.000 claims description 167
- 229940028334 follicle stimulating hormone Drugs 0.000 claims description 166
- SQVRNKJHWKZAKO-UHFFFAOYSA-N beta-N-Acetyl-D-neuraminic acid Natural products CC(=O)NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO SQVRNKJHWKZAKO-UHFFFAOYSA-N 0.000 claims description 104
- SQVRNKJHWKZAKO-OQPLDHBCSA-N sialic acid Chemical compound CC(=O)N[C@@H]1[C@@H](O)C[C@@](O)(C(O)=O)OC1[C@H](O)[C@H](O)CO SQVRNKJHWKZAKO-OQPLDHBCSA-N 0.000 claims description 102
- 230000009450 sialylation Effects 0.000 claims description 26
- 108090000623 proteins and genes Proteins 0.000 claims description 23
- 102000004169 proteins and genes Human genes 0.000 claims description 20
- 238000004519 manufacturing process Methods 0.000 claims description 12
- 239000008194 pharmaceutical composition Substances 0.000 claims description 11
- 210000005260 human cell Anatomy 0.000 claims description 8
- 239000000654 additive Substances 0.000 claims description 4
- 230000036512 infertility Effects 0.000 claims description 4
- 208000000509 infertility Diseases 0.000 claims description 4
- 231100000535 infertility Toxicity 0.000 claims description 3
- 230000000996 additive effect Effects 0.000 claims 3
- 230000001681 protective effect Effects 0.000 claims 2
- 238000002360 preparation method Methods 0.000 abstract description 25
- 210000004027 cell Anatomy 0.000 description 55
- 239000000047 product Substances 0.000 description 47
- 102000004190 Enzymes Human genes 0.000 description 20
- 229940088597 hormone Drugs 0.000 description 20
- 239000005556 hormone Substances 0.000 description 20
- 108090000790 Enzymes Proteins 0.000 description 18
- 102000003838 Sialyltransferases Human genes 0.000 description 18
- 108090000141 Sialyltransferases Proteins 0.000 description 18
- 150000004676 glycans Chemical class 0.000 description 17
- 235000018102 proteins Nutrition 0.000 description 17
- 210000002700 urine Anatomy 0.000 description 17
- 102000009151 Luteinizing Hormone Human genes 0.000 description 13
- 108010073521 Luteinizing Hormone Proteins 0.000 description 13
- 239000002253 acid Substances 0.000 description 13
- 239000000203 mixture Substances 0.000 description 13
- 229940040129 luteinizing hormone Drugs 0.000 description 12
- 102000001708 Protein Isoforms Human genes 0.000 description 11
- 108010029485 Protein Isoforms Proteins 0.000 description 11
- 239000000463 material Substances 0.000 description 10
- 238000004458 analytical method Methods 0.000 description 9
- 238000002474 experimental method Methods 0.000 description 9
- 239000013604 expression vector Substances 0.000 description 9
- 125000005629 sialic acid group Chemical group 0.000 description 8
- 108090000288 Glycoproteins Proteins 0.000 description 7
- 102000003886 Glycoproteins Human genes 0.000 description 7
- 241000700159 Rattus Species 0.000 description 7
- 230000014509 gene expression Effects 0.000 description 7
- 229940057854 gonal f Drugs 0.000 description 7
- 239000013598 vector Substances 0.000 description 7
- 108091026890 Coding region Proteins 0.000 description 6
- 108020004414 DNA Proteins 0.000 description 6
- 150000001413 amino acids Chemical class 0.000 description 6
- MSWZFWKMSRAUBD-UHFFFAOYSA-N beta-D-galactosamine Natural products NC1C(O)OC(CO)C(O)C1O MSWZFWKMSRAUBD-UHFFFAOYSA-N 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 238000001962 electrophoresis Methods 0.000 description 6
- 239000003446 ligand Substances 0.000 description 6
- 239000002609 medium Substances 0.000 description 6
- 230000004048 modification Effects 0.000 description 6
- 238000012986 modification Methods 0.000 description 6
- 230000002611 ovarian Effects 0.000 description 6
- 229920001184 polypeptide Polymers 0.000 description 6
- 102000004196 processed proteins & peptides Human genes 0.000 description 6
- 108090000765 processed proteins & peptides Proteins 0.000 description 6
- 102000005962 receptors Human genes 0.000 description 6
- 108020003175 receptors Proteins 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 102100031974 CMP-N-acetylneuraminate-beta-galactosamide-alpha-2,3-sialyltransferase 4 Human genes 0.000 description 5
- 238000002965 ELISA Methods 0.000 description 5
- 230000002378 acidificating effect Effects 0.000 description 5
- 229940024606 amino acid Drugs 0.000 description 5
- 235000001014 amino acid Nutrition 0.000 description 5
- 108010044715 asialofetuin Proteins 0.000 description 5
- 238000010353 genetic engineering Methods 0.000 description 5
- 229960002442 glucosamine Drugs 0.000 description 5
- 208000015181 infectious disease Diseases 0.000 description 5
- 230000002503 metabolic effect Effects 0.000 description 5
- 210000002966 serum Anatomy 0.000 description 5
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 description 4
- 102000005427 Asialoglycoprotein Receptor Human genes 0.000 description 4
- 108010002913 Asialoglycoproteins Proteins 0.000 description 4
- 108090001090 Lectins Proteins 0.000 description 4
- 102000004856 Lectins Human genes 0.000 description 4
- LCTONWCANYUPML-UHFFFAOYSA-N Pyruvic acid Chemical compound CC(=O)C(O)=O LCTONWCANYUPML-UHFFFAOYSA-N 0.000 description 4
- 238000010306 acid treatment Methods 0.000 description 4
- 210000004198 anterior pituitary gland Anatomy 0.000 description 4
- 108010006523 asialoglycoprotein receptor Proteins 0.000 description 4
- 102000035824 beta Subunit Follicle Stimulating Hormone Human genes 0.000 description 4
- 108010081485 beta Subunit Follicle Stimulating Hormone Proteins 0.000 description 4
- 210000004978 chinese hamster ovary cell Anatomy 0.000 description 4
- 230000007423 decrease Effects 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 230000012010 growth Effects 0.000 description 4
- 238000004128 high performance liquid chromatography Methods 0.000 description 4
- 239000002523 lectin Substances 0.000 description 4
- 238000004305 normal phase HPLC Methods 0.000 description 4
- 230000016087 ovulation Effects 0.000 description 4
- 239000013612 plasmid Substances 0.000 description 4
- 241000699802 Cricetulus griseus Species 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 101000863864 Homo sapiens Beta-galactoside alpha-2,6-sialyltransferase 1 Proteins 0.000 description 3
- 101000703754 Homo sapiens CMP-N-acetylneuraminate-beta-galactosamide-alpha-2,3-sialyltransferase 4 Proteins 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 230000027455 binding Effects 0.000 description 3
- 238000009739 binding Methods 0.000 description 3
- 125000000837 carbohydrate group Chemical group 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 230000005684 electric field Effects 0.000 description 3
- 230000013595 glycosylation Effects 0.000 description 3
- 238000006206 glycosylation reaction Methods 0.000 description 3
- 239000007972 injectable composition Substances 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- 239000003550 marker Substances 0.000 description 3
- 239000002773 nucleotide Substances 0.000 description 3
- 125000003729 nucleotide group Chemical group 0.000 description 3
- -1 organic esters ethyl oleate Chemical class 0.000 description 3
- 210000001672 ovary Anatomy 0.000 description 3
- 230000000144 pharmacologic effect Effects 0.000 description 3
- 230000001817 pituitary effect Effects 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 238000000746 purification Methods 0.000 description 3
- 238000011002 quantification Methods 0.000 description 3
- 230000001850 reproductive effect Effects 0.000 description 3
- 108091008146 restriction endonucleases Proteins 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 235000000346 sugar Nutrition 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- QRXMUCSWCMTJGU-UHFFFAOYSA-L (5-bromo-4-chloro-1h-indol-3-yl) phosphate Chemical compound C1=C(Br)C(Cl)=C2C(OP([O-])(=O)[O-])=CNC2=C1 QRXMUCSWCMTJGU-UHFFFAOYSA-L 0.000 description 2
- 101710186708 Agglutinin Proteins 0.000 description 2
- 102100029945 Beta-galactoside alpha-2,6-sialyltransferase 1 Human genes 0.000 description 2
- 101710083574 CMP-N-acetylneuraminate-beta-galactosamide-alpha-2,3-sialyltransferase 4 Proteins 0.000 description 2
- 238000012286 ELISA Assay Methods 0.000 description 2
- YQYJSBFKSSDGFO-UHFFFAOYSA-N Epihygromycin Natural products OC1C(O)C(C(=O)C)OC1OC(C(=C1)O)=CC=C1C=C(C)C(=O)NC1C(O)C(O)C2OCOC2C1O YQYJSBFKSSDGFO-UHFFFAOYSA-N 0.000 description 2
- 101710146024 Horcolin Proteins 0.000 description 2
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 description 2
- 101710189395 Lectin Proteins 0.000 description 2
- 101710179758 Mannose-specific lectin Proteins 0.000 description 2
- 101710150763 Mannose-specific lectin 1 Proteins 0.000 description 2
- 101710150745 Mannose-specific lectin 2 Proteins 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 102000003979 Mineralocorticoid Receptors Human genes 0.000 description 2
- 108090000375 Mineralocorticoid Receptors Proteins 0.000 description 2
- 102000005348 Neuraminidase Human genes 0.000 description 2
- 108010006232 Neuraminidase Proteins 0.000 description 2
- 239000000020 Nitrocellulose Substances 0.000 description 2
- 102000000447 Peptide-N4-(N-acetyl-beta-glucosaminyl) Asparagine Amidase Human genes 0.000 description 2
- 108010055817 Peptide-N4-(N-acetyl-beta-glucosaminyl) Asparagine Amidase Proteins 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 239000000910 agglutinin Substances 0.000 description 2
- 102000002287 alpha Subunit Glycoprotein Hormones Human genes 0.000 description 2
- 108010000732 alpha Subunit Glycoprotein Hormones Proteins 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- AFYNADDZULBEJA-UHFFFAOYSA-N bicinchoninic acid Chemical compound C1=CC=CC2=NC(C=3C=C(C4=CC=CC=C4N=3)C(=O)O)=CC(C(O)=O)=C21 AFYNADDZULBEJA-UHFFFAOYSA-N 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 235000014633 carbohydrates Nutrition 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000003638 chemical reducing agent Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 230000033581 fucosylation Effects 0.000 description 2
- 229930182830 galactose Natural products 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 230000002068 genetic effect Effects 0.000 description 2
- 210000004368 gonadotroph Anatomy 0.000 description 2
- 239000001963 growth medium Substances 0.000 description 2
- 150000002430 hydrocarbons Chemical class 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 238000002372 labelling Methods 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 230000033001 locomotion Effects 0.000 description 2
- 238000006452 multicomponent reaction Methods 0.000 description 2
- JPXMTWWFLBLUCD-UHFFFAOYSA-N nitro blue tetrazolium(2+) Chemical compound COC1=CC(C=2C=C(OC)C(=CC=2)[N+]=2N(N=C(N=2)C=2C=CC=CC=2)C=2C=CC(=CC=2)[N+]([O-])=O)=CC=C1[N+]1=NC(C=2C=CC=CC=2)=NN1C1=CC=C([N+]([O-])=O)C=C1 JPXMTWWFLBLUCD-UHFFFAOYSA-N 0.000 description 2
- 229920001220 nitrocellulos Polymers 0.000 description 2
- 229920001542 oligosaccharide Polymers 0.000 description 2
- 150000002482 oligosaccharides Chemical class 0.000 description 2
- 230000000624 ovulatory effect Effects 0.000 description 2
- 229920002401 polyacrylamide Polymers 0.000 description 2
- 230000036515 potency Effects 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 2
- 229940107700 pyruvic acid Drugs 0.000 description 2
- 239000002684 recombinant hormone Substances 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 239000012679 serum free medium Substances 0.000 description 2
- 238000009097 single-agent therapy Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 150000003431 steroids Chemical class 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 238000013519 translation Methods 0.000 description 2
- 230000002485 urinary effect Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- HORYNJCIACQHGZ-BHVWUGLYSA-N 1-[(3R,4R,5S,6R)-3-amino-2,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]ethanone Chemical compound C(C)(=O)C1(O)[C@H](N)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO HORYNJCIACQHGZ-BHVWUGLYSA-N 0.000 description 1
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 1
- MSWZFWKMSRAUBD-GASJEMHNSA-N 2-amino-2-deoxy-D-galactopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@H](O)[C@@H]1O MSWZFWKMSRAUBD-GASJEMHNSA-N 0.000 description 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N 4-hydroxybenzoic acid Chemical compound OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 1
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 1
- 241001136792 Alle Species 0.000 description 1
- DCXYFEDJOCDNAF-UHFFFAOYSA-N Asparagine Natural products OC(=O)C(N)CC(N)=O DCXYFEDJOCDNAF-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 102000011022 Chorionic Gonadotropin Human genes 0.000 description 1
- 108010062540 Chorionic Gonadotropin Proteins 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- SHZGCJCMOBCMKK-UHFFFAOYSA-N D-mannomethylose Natural products CC1OC(O)C(O)C(O)C1O SHZGCJCMOBCMKK-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 description 1
- GUBGYTABKSRVRQ-WFVLMXAXSA-N DEAE-cellulose Chemical compound OC1C(O)C(O)C(CO)O[C@H]1O[C@@H]1C(CO)OC(O)C(O)C1O GUBGYTABKSRVRQ-WFVLMXAXSA-N 0.000 description 1
- 101710088194 Dehydrogenase Proteins 0.000 description 1
- SHIBSTMRCDJXLN-UHFFFAOYSA-N Digoxigenin Natural products C1CC(C2C(C3(C)CCC(O)CC3CC2)CC2O)(O)C2(C)C1C1=CC(=O)OC1 SHIBSTMRCDJXLN-UHFFFAOYSA-N 0.000 description 1
- LVGKNOAMLMIIKO-UHFFFAOYSA-N Elaidinsaeure-aethylester Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC LVGKNOAMLMIIKO-UHFFFAOYSA-N 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 244000187656 Eucalyptus cornuta Species 0.000 description 1
- 102000008175 FSH Receptors Human genes 0.000 description 1
- 108010060374 FSH Receptors Proteins 0.000 description 1
- PNNNRSAQSRJVSB-SLPGGIOYSA-N Fucose Natural products C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)C=O PNNNRSAQSRJVSB-SLPGGIOYSA-N 0.000 description 1
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- 108700023372 Glycosyltransferases Proteins 0.000 description 1
- 101000863891 Homo sapiens Beta-galactoside alpha-2,6-sialyltransferase 2 Proteins 0.000 description 1
- 108010082302 Human Follicle Stimulating Hormone Proteins 0.000 description 1
- 102000003864 Human Follicle Stimulating Hormone Human genes 0.000 description 1
- 102000003839 Human Proteins Human genes 0.000 description 1
- 108090000144 Human Proteins Proteins 0.000 description 1
- DCXYFEDJOCDNAF-REOHCLBHSA-N L-asparagine Chemical compound OC(=O)[C@@H](N)CC(N)=O DCXYFEDJOCDNAF-REOHCLBHSA-N 0.000 description 1
- SHZGCJCMOBCMKK-DHVFOXMCSA-N L-fucopyranose Chemical compound C[C@@H]1OC(O)[C@@H](O)[C@H](O)[C@@H]1O SHZGCJCMOBCMKK-DHVFOXMCSA-N 0.000 description 1
- 229930182816 L-glutamine Natural products 0.000 description 1
- 241000234435 Lilium Species 0.000 description 1
- 241001521394 Maackia amurensis Species 0.000 description 1
- 102000048245 N-acetylneuraminate lyases Human genes 0.000 description 1
- 108700023220 N-acetylneuraminate lyases Proteins 0.000 description 1
- 229930193140 Neomycin Natural products 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 102000045595 Phosphoprotein Phosphatases Human genes 0.000 description 1
- 108700019535 Phosphoprotein Phosphatases Proteins 0.000 description 1
- 229920002732 Polyanhydride Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 229920001710 Polyorthoester Polymers 0.000 description 1
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 description 1
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 description 1
- 240000006028 Sambucus nigra Species 0.000 description 1
- 235000003142 Sambucus nigra Nutrition 0.000 description 1
- 229920005654 Sephadex Polymers 0.000 description 1
- 239000012507 Sephadex™ Substances 0.000 description 1
- 241001455273 Tetrapoda Species 0.000 description 1
- 102000011923 Thyrotropin Human genes 0.000 description 1
- 108010061174 Thyrotropin Proteins 0.000 description 1
- 125000002252 acyl group Chemical group 0.000 description 1
- 238000005377 adsorption chromatography Methods 0.000 description 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 description 1
- 230000003321 amplification Effects 0.000 description 1
- 238000005349 anion exchange Methods 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 239000003429 antifungal agent Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 229960001230 asparagine Drugs 0.000 description 1
- 235000009582 asparagine Nutrition 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 108010057005 beta-galactoside alpha-2,3-sialyltransferase Proteins 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 239000007844 bleaching agent Substances 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 239000006143 cell culture medium Substances 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 229960004926 chlorobutanol Drugs 0.000 description 1
- 229940015047 chorionic gonadotropin Drugs 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 230000001886 ciliary effect Effects 0.000 description 1
- 238000011260 co-administration Methods 0.000 description 1
- 239000002299 complementary DNA Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000012228 culture supernatant Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- QONQRTHLHBTMGP-UHFFFAOYSA-N digitoxigenin Natural products CC12CCC(C3(CCC(O)CC3CC3)C)C3C11OC1CC2C1=CC(=O)OC1 QONQRTHLHBTMGP-UHFFFAOYSA-N 0.000 description 1
- SHIBSTMRCDJXLN-KCZCNTNESA-N digoxigenin Chemical compound C1([C@@H]2[C@@]3([C@@](CC2)(O)[C@H]2[C@@H]([C@@]4(C)CC[C@H](O)C[C@H]4CC2)C[C@H]3O)C)=CC(=O)OC1 SHIBSTMRCDJXLN-KCZCNTNESA-N 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
- 235000013601 eggs Nutrition 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 229960005309 estradiol Drugs 0.000 description 1
- 229930182833 estradiol Natural products 0.000 description 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 1
- 229940093471 ethyl oleate Drugs 0.000 description 1
- 235000008995 european elder Nutrition 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 210000002468 fat body Anatomy 0.000 description 1
- 230000035558 fertility Effects 0.000 description 1
- 108060002885 fetuin Proteins 0.000 description 1
- 102000013361 fetuin Human genes 0.000 description 1
- 238000007667 floating Methods 0.000 description 1
- 108010006578 follitropin alfa Proteins 0.000 description 1
- 108010081934 follitropin beta Proteins 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 102000045442 glycosyltransferase activity proteins Human genes 0.000 description 1
- 108700014210 glycosyltransferase activity proteins Proteins 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 230000002710 gonadal effect Effects 0.000 description 1
- 102000048059 human St6Gal2 Human genes 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 238000010166 immunofluorescence Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000009027 insemination Effects 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000006194 liquid suspension Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 230000037323 metabolic rate Effects 0.000 description 1
- 239000004530 micro-emulsion Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 239000003094 microcapsule Substances 0.000 description 1
- 125000001483 monosaccharide substituent group Chemical group 0.000 description 1
- 150000002772 monosaccharides Chemical class 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 229930014626 natural product Natural products 0.000 description 1
- 229960004927 neomycin Drugs 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 238000003199 nucleic acid amplification method Methods 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 125000001181 organosilyl group Chemical group [SiH3]* 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 210000004303 peritoneum Anatomy 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000008063 pharmaceutical solvent Substances 0.000 description 1
- 229960003742 phenol Drugs 0.000 description 1
- 210000002826 placenta Anatomy 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 229940071643 prefilled syringe Drugs 0.000 description 1
- 239000013587 production medium Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 210000003370 receptor cell Anatomy 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 230000003248 secreting effect Effects 0.000 description 1
- 239000004017 serum-free culture medium Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 230000010473 stable expression Effects 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 239000003206 sterilizing agent Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000012916 structural analysis Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229960000874 thyrotropin Drugs 0.000 description 1
- 230000001748 thyrotropin Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical group COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 210000001215 vagina Anatomy 0.000 description 1
- 235000015112 vegetable and seed oil Nutrition 0.000 description 1
- 239000008158 vegetable oil Substances 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Classifications
-
- 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
- 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
- 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
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/10—Transferases (2.)
- C12N9/1048—Glycosyltransferases (2.4)
- C12N9/1081—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)
-
- 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)
-
- 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)
- Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Reproductive Health (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Wood Science & Technology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Toxicology (AREA)
- General Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Diabetes (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Plant Pathology (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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US4542408P | 2008-04-16 | 2008-04-16 | |
| EP08251528 | 2008-04-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SA109300228B1 true SA109300228B1 (ar) | 2014-04-08 |
Family
ID=39717519
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SA109300228A SA109300228B1 (ar) | 2008-04-16 | 2009-04-18 | تحضير صيدلاني من FSH مأشوب (rFSH) وعملية واستخدام التحضير الصيدلاني |
Country Status (29)
Families Citing this family (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
| TWI604850B (zh) | 2009-10-05 | 2017-11-11 | 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 |
| HRP20150968T4 (hr) | 2010-09-29 | 2023-11-10 | Ferring B.V. | Pripravak za uporabu za liječenje neplodnosti |
| KR101898302B1 (ko) | 2010-10-15 | 2018-09-13 | 제이씨알 파마 가부시키가이샤 | 당사슬의 비환원 말단이 만노오스 잔기인 당 단백질의 제조 방법 |
| CA2831486A1 (en) * | 2011-03-31 | 2012-10-04 | Ferring B.V. | Pharmaceutical preparation |
| AR090095A1 (es) | 2011-06-06 | 2014-10-22 | Ferring Bv | Preparacion farmaceutica que comprende hormona estimulante del foliculo recombinante |
| 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 |
| WO2013161958A1 (ja) * | 2012-04-27 | 2013-10-31 | 日本ケミカルリサーチ株式会社 | 新規な発現ベクター |
| 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 |
| JP2018500934A (ja) * | 2014-12-22 | 2018-01-18 | エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft | Cmp依存性シアリダーゼ活性 |
| ES2784625T3 (es) | 2015-04-17 | 2020-09-29 | Ferring Bv | FSH para el tratamiento de la infertilidad |
| EP3313859B1 (en) | 2015-06-26 | 2019-11-20 | Ferring BV | 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 |
| EP3441471A1 (en) | 2017-08-08 | 2019-02-13 | CEVEC Pharmaceuticals GmbH | Use of constitutively active variants of growth factor receptors as selection makers for the generation of stable producer cell lines |
| AR112541A1 (es) | 2017-09-01 | 2019-11-06 | Ferring Bv | Composición para estimulación ovárica controlada con hef recombinante |
| EP3787667B1 (en) | 2018-04-30 | 2025-03-26 | Ferring B.V. | Composition for controlled ovarian stimulation |
| TWI846743B (zh) | 2018-10-17 | 2024-07-01 | 荷蘭商菲林公司 | 用於控制性卵巢刺激之組成物及方法 |
| US20220380785A1 (en) * | 2019-11-01 | 2022-12-01 | 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 |
| US20250241993A1 (en) | 2022-04-01 | 2025-07-31 | Ferring B.V. | Mixed protocol for treatment of infertility |
| US20250333466A1 (en) | 2022-05-26 | 2025-10-30 | Ferring B.V. | Compositions and methods for treatment of infertility in males |
| AU2023302100A1 (en) | 2022-07-08 | 2025-01-02 | Ferring B.V. | Compositions and methods for intrauterine insemination (iui) |
| TW202504578A (zh) | 2023-07-20 | 2025-02-01 | 荷蘭商輝凌責任有限公司 | 緩釋載藥微粒 |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1206302B (it) | 1987-06-26 | 1989-04-14 | Serono Cesare Ist Ricerca | Ormone follicolo-stimolante urinario |
| US5541083A (en) | 1989-10-24 | 1996-07-30 | The Regents Of The University Of California | Method for producing secretable glycosyltransferases and other golgi processing enzymes |
| EP1445322B2 (en) | 1995-06-15 | 2012-06-06 | Crucell Holland B.V. | Packaging systems for human recombinant adenovirus to be used in gene therapy |
| JP3559652B2 (ja) * | 1996-06-25 | 2004-09-02 | グローリー工業株式会社 | 売上精算システムの管理装置 |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| JP2001507215A (ja) | 1997-01-16 | 2001-06-05 | サイテル コーポレイション | 組換え糖タンパク質のインビトロでの実用的なシアリル化 |
| JPH1111665A (ja) | 1997-06-28 | 1999-01-19 | Shibuya Kogyo Co Ltd | 無菌エア搬送コンベヤ装置 |
| TWI235158B (en) * | 1997-09-01 | 2005-07-01 | Kirin Brewery | Human thrombopoietin produced by human established cell lines, processes foe preparing the same, and pharmaceutical composition comprising the same |
| EP1176976B2 (en) | 1999-05-07 | 2015-10-21 | Laboratoires Serono SA | Use of lh administered in mid- or late-follicular phase for the treatment of anovulatory women |
| JP2002011665A (ja) | 2000-06-28 | 2002-01-15 | Sintokogio Ltd | ショットブラスト装置モニタシステム |
| IL140110A0 (en) | 2000-12-05 | 2002-02-10 | Applied Research Systems | Improvement of homogeneity and secretion of recombinant proteins in mammalian systems |
| EP1621549A3 (en) * | 2001-10-22 | 2006-03-01 | Applied Research Systems ARS Holding N.V. | Compositions of fsh with high sialylation degree and their use for the preparation of medicinaments |
| BR0213402A (pt) | 2001-10-29 | 2004-10-13 | Crucell Holland Bv | Métodos para identificar uma célula de mamìfero capaz de produzir uma molécula proteinácea, para selecionar uma célula de mamìfero capaz de produzir uma molécula proteinácea, para se obter uma célula de mamìfero a partir de uma população heterogênea de células, e para produzir uma molécula proteinácea, composição farmaceuticamente aceitável, eritropoietina recombinantemente produzida, usos de uma célula de mamìfero, da eritropoietina recombinantemente produzida, e de uma composição de moléculas semelhantes à eritropoietina, preparação farmacêutica, método para o tratamento preventivo e/ou terapêutico de um distúrbio, composição de moléculas semelhates à eritropoietina, métodos para produzir, em uma célula de mamìfero, moléculas proteináceas, para produzir uma fração enriquecida em uma molécula proteinácea, e para fracionar uma mistura que contém moléculas proteináceas, fração, e, usos de uma fração ou composição, e de eritropoietina recombinantemente produzìvel em uma célula de mamìfero |
| CA2468957C (en) | 2001-12-07 | 2011-07-12 | Crucell Holland B.V. | Methods of propagation of influenza virus in cell lines over expressing sialyl transferases |
| US20040248784A1 (en) * | 2003-06-03 | 2004-12-09 | Marco Filicori | Unitary combinations of FSH and hCG |
| US20080015142A1 (en) * | 2003-12-03 | 2008-01-17 | Defrees Shawn | Glycopegylated Follicle Stimulating Hormone |
| DK1711834T3 (da) | 2004-02-04 | 2010-11-29 | Centre Nat Rech Scient | Fremgangsmåde til screening af glycoform-specifikke antistoffer |
| CN1926242B (zh) | 2004-02-13 | 2013-01-16 | 格莱克托普有限公司 | 高活性糖蛋白加工条件及其有效生产方法 |
| TWI488640B (zh) | 2008-04-16 | 2015-06-21 | Ferring Int Ct Sa | 藥學製劑 |
| TWI604850B (zh) | 2009-10-05 | 2017-11-11 | 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 |
| WO2012016575A1 (en) | 2010-08-03 | 2012-02-09 | King Saud University | Stoma coat |
| WO2012016576A1 (en) * | 2010-08-04 | 2012-02-09 | Glycotope Gmbh | Improved recombinant human follicle-stimulating hormone |
| HRP20150968T4 (hr) | 2010-09-29 | 2023-11-10 | Ferring B.V. | Pripravak za uporabu za liječenje neplodnosti |
| CA2831486A1 (en) | 2011-03-31 | 2012-10-04 | Ferring B.V. | Pharmaceutical preparation |
| AR090095A1 (es) | 2011-06-06 | 2014-10-22 | Ferring Bv | Preparacion farmaceutica que comprende hormona estimulante del foliculo recombinante |
| JO3092B1 (ar) | 2011-08-08 | 2017-03-15 | Ferring Bv | مركب لتحفيز مسيطر عليه للمبيض |
| US20170035854A1 (en) | 2014-04-18 | 2017-02-09 | Glycotope Gmbh | Controlled ovarian hyperstimulation with improved recombinant human follicle-stimulating hormone |
-
2009
- 2009-04-15 TW TW098112483A patent/TWI488640B/zh active
- 2009-04-16 SI SI200932209T patent/SI4015527T1/sl unknown
- 2009-04-16 ES ES14178729.1T patent/ES2610277T3/es active Active
- 2009-04-16 LT LTEP16158141.8T patent/LT3045471T/lt unknown
- 2009-04-16 HU HUE16179121A patent/HUE068565T2/hu unknown
- 2009-04-16 EP EP16179121.5A patent/EP3098234B1/en active Active
- 2009-04-16 LT LTEP14178729.1T patent/LT2808340T/lt unknown
- 2009-04-16 CN CN201510933782.9A patent/CN105906702A/zh active Pending
- 2009-04-16 PT PT161791215T patent/PT3098234T/pt unknown
- 2009-04-16 PL PL16194925T patent/PL3144318T3/pl unknown
- 2009-04-16 PL PL16158141T patent/PL3045471T3/pl unknown
- 2009-04-16 BR BRPI0910461A patent/BRPI0910461B8/pt active IP Right Grant
- 2009-04-16 DK DK16194925.0T patent/DK3144318T3/da active
- 2009-04-16 ES ES16158141.8T patent/ES2629392T3/es active Active
- 2009-04-16 EP EP13193214.7A patent/EP2722339A1/en active Pending
- 2009-04-16 KR KR1020197022294A patent/KR102108377B1/ko active Active
- 2009-04-16 DK DK14178729.1T patent/DK2808340T3/en active
- 2009-04-16 LT LTEP21212873.0T patent/LT4015527T/lt unknown
- 2009-04-16 PT PT212128730T patent/PT4015527T/pt unknown
- 2009-04-16 PT PT141787291T patent/PT2808340T/pt unknown
- 2009-04-16 KR KR1020167012148A patent/KR20160056960A/ko not_active Ceased
- 2009-04-16 EP EP16194925.0A patent/EP3144318B1/en active Active
- 2009-04-16 HU HUE14178729A patent/HUE030652T4/en unknown
- 2009-04-16 AU AU2009237479A patent/AU2009237479B2/en active Active
- 2009-04-16 ES ES09733497.3T patent/ES2468318T3/es active Active
- 2009-04-16 DK DK16158141.8T patent/DK3045471T3/en active
- 2009-04-16 CA CA2725257A patent/CA2725257A1/en active Pending
- 2009-04-16 ES ES21212873T patent/ES3023526T3/es active Active
- 2009-04-16 JP JP2011504527A patent/JP2011519359A/ja active Pending
- 2009-04-16 HR HRP20241187TT patent/HRP20241187T1/hr unknown
- 2009-04-16 EP EP14178729.1A patent/EP2808340B1/en not_active Revoked
- 2009-04-16 DK DK16179121.5T patent/DK3098234T3/da active
- 2009-04-16 MX MX2010011343A patent/MX2010011343A/es active IP Right Grant
- 2009-04-16 SI SI200930931T patent/SI2268666T1/sl unknown
- 2009-04-16 NZ NZ588381A patent/NZ588381A/en unknown
- 2009-04-16 ES ES16179121T patent/ES2989729T3/es active Active
- 2009-04-16 SI SI200932094T patent/SI3144318T1/sl unknown
- 2009-04-16 MX MX2017007881A patent/MX355457B/es unknown
- 2009-04-16 PL PL16179121.5T patent/PL3098234T3/pl unknown
- 2009-04-16 US US12/988,218 patent/US8951967B2/en active Active
- 2009-04-16 CN CN200980121391XA patent/CN102066414A/zh active Pending
- 2009-04-16 HR HRP20140535AT patent/HRP20140535T1/hr unknown
- 2009-04-16 WO PCT/GB2009/000978 patent/WO2009127826A1/en not_active Ceased
- 2009-04-16 DK DK21212873.0T patent/DK4015527T3/da active
- 2009-04-16 PT PT161581418T patent/PT3045471T/pt unknown
- 2009-04-16 KR KR1020177026920A patent/KR20170110741A/ko not_active Ceased
- 2009-04-16 FI FIEP16179121.5T patent/FI3098234T3/fi active
- 2009-04-16 PL PL21212873.0T patent/PL4015527T3/pl unknown
- 2009-04-16 KR KR1020187023820A patent/KR20180095140A/ko not_active Ceased
- 2009-04-16 KR KR1020107025581A patent/KR101622944B1/ko active Active
- 2009-04-16 SI SI200931547A patent/SI2808340T1/sl unknown
- 2009-04-16 RU RU2010141908/10A patent/RU2537268C2/ru active
- 2009-04-16 HR HRP20250313TT patent/HRP20250313T1/hr unknown
- 2009-04-16 PL PL09733497T patent/PL2268666T3/pl unknown
- 2009-04-16 EP EP16158141.8A patent/EP3045471B1/en not_active Revoked
- 2009-04-16 EP EP09733497.3A patent/EP2268666B1/en not_active Revoked
- 2009-04-16 EP EP21212873.0A patent/EP4015527B1/en active Active
- 2009-04-16 RU RU2014141994A patent/RU2682270C2/ru active
- 2009-04-16 FI FIEP21212873.0T patent/FI4015527T3/fi active
- 2009-04-16 CN CN201510933827.2A patent/CN105906703A/zh active Pending
- 2009-04-16 SI SI200931670A patent/SI3045471T1/sl unknown
- 2009-04-16 LT LTEP16179121.5T patent/LT3098234T/lt unknown
- 2009-04-16 DK DK09733497.3T patent/DK2268666T3/da active
- 2009-04-16 PT PT97334973T patent/PT2268666E/pt unknown
- 2009-04-16 SI SI200932205T patent/SI3098234T1/sl unknown
- 2009-04-16 PT PT161949250T patent/PT3144318T/pt unknown
- 2009-04-16 PL PL14178729T patent/PL2808340T3/pl unknown
- 2009-04-16 MX MX2014011348A patent/MX348622B/es unknown
- 2009-04-16 HU HUE21212873A patent/HUE071059T2/hu unknown
- 2009-04-16 AR ARP090101333A patent/AR071479A1/es not_active Application Discontinuation
- 2009-04-16 HU HUE16158141A patent/HUE033830T2/en unknown
- 2009-04-18 SA SA109300228A patent/SA109300228B1/ar unknown
-
2010
- 2010-10-07 IL IL208538A patent/IL208538A/en active Protection Beyond IP Right Term
- 2010-10-14 ZA ZA2010/07373A patent/ZA201007373B/en unknown
-
2014
- 2014-01-21 IL IL230571A patent/IL230571A/en active IP Right Grant
- 2014-06-06 CY CY20141100402T patent/CY1115413T1/el unknown
- 2014-06-17 AU AU2014203277A patent/AU2014203277C1/en active Active
- 2014-11-14 US US14/541,852 patent/US9546204B2/en active Active
- 2014-12-25 JP JP2014262056A patent/JP2015120696A/ja active Pending
-
2016
- 2016-08-16 US US15/238,362 patent/US9771407B2/en active Active
- 2016-10-07 JP JP2016198588A patent/JP6486310B2/ja active Active
- 2016-11-16 HR HRP20161520TT patent/HRP20161520T1/hr unknown
-
2017
- 2017-05-30 HU HUS1700024C patent/HUS1700024I1/hu unknown
- 2017-05-31 HU HUS1700025C patent/HUS1700025I1/hu unknown
- 2017-06-05 LT LTPA2017018C patent/LTPA2017018I1/lt unknown
- 2017-06-06 FR FR17C1020C patent/FR17C1020I2/fr active Active
- 2017-06-06 NO NO2017025C patent/NO2017025I1/no unknown
- 2017-06-23 AU AU2017204258A patent/AU2017204258B2/en active Active
- 2017-06-23 AU AU2017204259A patent/AU2017204259B2/en active Active
- 2017-06-26 HR HRP20170958TT patent/HRP20170958T1/hr unknown
- 2017-08-01 JP JP2017148823A patent/JP6762916B2/ja active Active
- 2017-08-29 US US15/690,061 patent/US10995128B2/en active Active
- 2017-09-05 AU AU2017225020A patent/AU2017225020B2/en active Active
- 2017-09-27 HU HUS1700036C patent/HUS1700036I1/hu unknown
- 2017-09-27 LT LTPA2017029C patent/LTPA2017029I1/lt unknown
- 2017-09-28 NO NO2017050C patent/NO2017050I1/no unknown
-
2018
- 2018-11-08 RU RU2018139379A patent/RU2745557C3/ru active Protection Beyond IP Right Term
-
2019
- 2019-10-25 JP JP2019194476A patent/JP7316905B2/ja active Active
-
2021
- 2021-04-30 US US17/246,348 patent/US11952407B2/en active Active
- 2021-10-27 JP JP2021175403A patent/JP2022031652A/ja active Pending
-
2023
- 2023-12-21 JP JP2023215339A patent/JP2024038000A/ja active Pending
-
2024
- 2024-03-14 US US18/605,381 patent/US20240327487A1/en active Pending
-
2025
- 2025-01-15 FI FIC20250003C patent/FIC20250003I1/fi unknown
- 2025-01-16 FR FR25C1003C patent/FR25C1003I1/fr active Active
- 2025-01-16 NO NO2025006C patent/NO2025006I1/no unknown
- 2025-01-24 LT LTPA2025505C patent/LTPA2025505I1/lt unknown
- 2025-01-28 HU HUS2500008C patent/HUS2500008I1/hu unknown
- 2025-07-02 FR FR25C1025C patent/FR25C1025I1/fr active Active
- 2025-07-07 LT LTPA2025525C patent/LTPA2025525I1/lt unknown
- 2025-07-07 HU HUS2500029C patent/HUS2500029I1/hu unknown
- 2025-07-11 FI FIC20250025C patent/FIC20250025I1/fi unknown
- 2025-07-14 NO NO2025032C patent/NO2025032I1/no unknown
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP7316905B2 (ja) | アルファ2,3-およびアルファ2,6-シアリル化を含む組換えfsh | |
| HK40068781B (en) | Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation | |
| HK40068781A (en) | Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation | |
| HK1146284B (en) | Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation | |
| HK1197825A (en) | Recombinant fsh including alpha 2,3-and alpha 2,6-sialylation | |
| HK1199039B (en) | Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation |