CA2944330A1 - Liquid pharmaceutical composition of adalimumab - Google Patents
Liquid pharmaceutical composition of adalimumab Download PDFInfo
- Publication number
- CA2944330A1 CA2944330A1 CA2944330A CA2944330A CA2944330A1 CA 2944330 A1 CA2944330 A1 CA 2944330A1 CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A1 CA2944330 A1 CA 2944330A1
- Authority
- CA
- Canada
- Prior art keywords
- formulation
- adalimumab
- buffer
- pharmaceutical composition
- antibody
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 41
- 229960002964 adalimumab Drugs 0.000 title claims description 32
- 239000007788 liquid Substances 0.000 title abstract description 7
- 239000000872 buffer Substances 0.000 claims abstract description 48
- 239000003381 stabilizer Substances 0.000 claims abstract description 19
- 239000004094 surface-active agent Substances 0.000 claims abstract description 19
- 239000000203 mixture Substances 0.000 claims description 137
- 238000009472 formulation Methods 0.000 claims description 130
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 26
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 14
- 229930006000 Sucrose Natural products 0.000 claims description 14
- 239000005720 sucrose Substances 0.000 claims description 14
- 239000004475 Arginine Substances 0.000 claims description 13
- 239000004471 Glycine Substances 0.000 claims description 13
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 13
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 11
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 10
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 10
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 10
- 229920000053 polysorbate 80 Polymers 0.000 claims description 10
- 229940068968 polysorbate 80 Drugs 0.000 claims description 10
- 239000008351 acetate buffer Substances 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 description 23
- 108090000623 proteins and genes Proteins 0.000 description 23
- 238000000034 method Methods 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- 238000001542 size-exclusion chromatography Methods 0.000 description 8
- 108060008682 Tumor Necrosis Factor Proteins 0.000 description 7
- 239000007853 buffer solution Substances 0.000 description 6
- 230000008859 change Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- -1 glucose and mannose Chemical class 0.000 description 6
- 238000004128 high performance liquid chromatography Methods 0.000 description 6
- 238000003860 storage Methods 0.000 description 6
- 230000002776 aggregation Effects 0.000 description 5
- 238000004220 aggregation Methods 0.000 description 5
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 5
- 239000002736 nonionic surfactant Substances 0.000 description 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 4
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 4
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 description 4
- 230000002378 acidificating effect Effects 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 230000007774 longterm Effects 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 229920005862 polyol Polymers 0.000 description 4
- 150000003077 polyols Chemical class 0.000 description 4
- 229920000136 polysorbate Polymers 0.000 description 4
- 229950008882 polysorbate Drugs 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 4
- 238000001179 sorption measurement Methods 0.000 description 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 3
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 3
- 102000004127 Cytokines Human genes 0.000 description 3
- 108090000695 Cytokines Proteins 0.000 description 3
- 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 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 3
- 108020004511 Recombinant DNA Proteins 0.000 description 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 3
- 102100040247 Tumor necrosis factor Human genes 0.000 description 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 3
- 150000001413 amino acids Chemical class 0.000 description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 3
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 3
- 238000004166 bioassay Methods 0.000 description 3
- 239000013022 formulation composition Substances 0.000 description 3
- 238000004108 freeze drying Methods 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- 238000000338 in vitro Methods 0.000 description 3
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 3
- 238000002823 phage display Methods 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 150000005846 sugar alcohols Chemical class 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- 239000000811 xylitol Substances 0.000 description 3
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 3
- 235000010447 xylitol Nutrition 0.000 description 3
- 229960002675 xylitol Drugs 0.000 description 3
- MZOFCQQQCNRIBI-VMXHOPILSA-N (3s)-4-[[(2s)-1-[[(2s)-1-[[(1s)-1-carboxy-2-hydroxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-[[2-[[(2s)-2,6-diaminohexanoyl]amino]acetyl]amino]-4-oxobutanoic acid Chemical compound OC[C@@H](C(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](N)CCCCN MZOFCQQQCNRIBI-VMXHOPILSA-N 0.000 description 2
- 101000611183 Homo sapiens Tumor necrosis factor Proteins 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 2
- 201000001263 Psoriatic Arthritis Diseases 0.000 description 2
- 208000036824 Psoriatic arthropathy Diseases 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 239000013011 aqueous formulation Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003124 biologic agent Substances 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 230000001472 cytotoxic effect Effects 0.000 description 2
- 238000004925 denaturation Methods 0.000 description 2
- 230000036425 denaturation Effects 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
- 102000057041 human TNF Human genes 0.000 description 2
- 230000002779 inactivation Effects 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 239000002563 ionic surfactant Substances 0.000 description 2
- 210000004962 mammalian cell Anatomy 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- 150000002772 monosaccharides Chemical class 0.000 description 2
- 229960000502 poloxamer Drugs 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 229920001184 polypeptide Polymers 0.000 description 2
- 102000004196 processed proteins & peptides Human genes 0.000 description 2
- 108090000765 processed proteins & peptides Proteins 0.000 description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 230000003612 virological effect Effects 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 206010048998 Acute phase reaction Diseases 0.000 description 1
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 206010009900 Colitis ulcerative Diseases 0.000 description 1
- 208000011231 Crohn disease Diseases 0.000 description 1
- 108010008165 Etanercept Proteins 0.000 description 1
- 230000005526 G1 to G0 transition Effects 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 208000003456 Juvenile Arthritis Diseases 0.000 description 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 201000004681 Psoriasis Diseases 0.000 description 1
- 108700012920 TNF Proteins 0.000 description 1
- 101150046432 Tril gene Proteins 0.000 description 1
- 108060008683 Tumor Necrosis Factor Receptor Proteins 0.000 description 1
- 201000006704 Ulcerative Colitis Diseases 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000004658 acute-phase response Effects 0.000 description 1
- 150000003862 amino acid derivatives Chemical class 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 235000014121 butter Nutrition 0.000 description 1
- 229960003115 certolizumab pegol Drugs 0.000 description 1
- 239000004927 clay Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 231100000433 cytotoxic Toxicity 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 229940073621 enbrel Drugs 0.000 description 1
- 239000012537 formulation buffer Substances 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- 230000005661 hydrophobic surface Effects 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 229960000598 infliximab Drugs 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000004255 ion exchange chromatography Methods 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 229940126619 mouse monoclonal antibody Drugs 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 230000001766 physiological effect Effects 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
- 230000000770 proinflammatory effect Effects 0.000 description 1
- 239000012460 protein solution Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 229940116176 remicade Drugs 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000012488 sample solution Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000012496 stress study Methods 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000001757 thermogravimetry curve Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 239000013638 trimer Substances 0.000 description 1
- 229940046728 tumor necrosis factor alpha inhibitor Drugs 0.000 description 1
- 239000002452 tumor necrosis factor alpha inhibitor Substances 0.000 description 1
- 102000003298 tumor necrosis factor receptor Human genes 0.000 description 1
- 239000003981 vehicle Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN1248/MUM/2014 | 2014-04-02 | ||
| PCT/IN2015/000092 WO2015151115A1 (en) | 2014-04-02 | 2015-02-18 | Liquid pharmaceutical composition of adalimumab |
| IN1248MU2014 IN2014MU01248A (OSRAM) | 2014-04-02 | 2015-02-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2944330A1 true CA2944330A1 (en) | 2015-10-08 |
Family
ID=54239505
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2944330A Abandoned CA2944330A1 (en) | 2014-04-02 | 2015-02-18 | Liquid pharmaceutical composition of adalimumab |
Country Status (5)
| Country | Link |
|---|---|
| US (2) | US10688187B2 (OSRAM) |
| EP (1) | EP3125928A4 (OSRAM) |
| CA (1) | CA2944330A1 (OSRAM) |
| IN (1) | IN2014MU01248A (OSRAM) |
| WO (1) | WO2015151115A1 (OSRAM) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3050557A1 (en) | 2014-05-23 | 2016-08-03 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3479819B1 (en) * | 2016-06-30 | 2024-01-24 | Celltrion Inc. | Stable liquid pharmaceutical preparation |
| EP4467565A3 (en) | 2016-12-21 | 2025-03-12 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| CN110167531B (zh) * | 2017-01-11 | 2025-06-03 | 赛特瑞恩股份有限公司 | 稳定的液体调配物 |
| MX2019010895A (es) * | 2017-03-16 | 2019-11-05 | Lg Chemical Ltd | Formulacion liquida de anticuerpo anti-tnf alfa. |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| EP3941521A1 (en) * | 2019-03-18 | 2022-01-26 | Alvotech HF | Aqueous formulations of tnf-alpha antibodies in high concentrations |
| EP4037703A4 (en) * | 2019-10-02 | 2023-12-06 | Alamab Therapeutics, Inc. | ANTI-CONNEXIN ANTIBODY FORMULATIONS |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5580856A (en) | 1994-07-15 | 1996-12-03 | Prestrelski; Steven J. | Formulation of a reconstituted protein, and method and kit for the production thereof |
| DK0929578T3 (da) | 1996-02-09 | 2003-08-25 | Abbott Lab Bermuda Ltd | Humane antistoffer, der binder human TNFalfa |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| DK1314437T3 (da) | 2000-08-11 | 2014-07-14 | Chugai Pharmaceutical Co Ltd | Stabiliserede antistofindeholdende præparater |
| DK1478394T3 (da) * | 2002-02-27 | 2008-10-13 | Immunex Corp | Stabiliseret TNFR-Fc formulation med arginin |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| KR20150080038A (ko) | 2007-11-30 | 2015-07-08 | 애브비 바이오테크놀로지 리미티드 | 단백질 제형 및 이의 제조방법 |
| US8821865B2 (en) * | 2010-11-11 | 2014-09-02 | Abbvie Biotechnology Ltd. | High concentration anti-TNFα antibody liquid formulations |
| AU2012328524B2 (en) | 2011-10-28 | 2017-05-18 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| KR101730694B1 (ko) | 2012-03-07 | 2017-04-27 | 카딜라 핼쓰캐어 리미티드 | TNF-α 항체의 약제학적 제형 |
| FR2994390B1 (fr) * | 2012-08-10 | 2014-08-15 | Adocia | Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee |
| PE20191815A1 (es) | 2012-09-07 | 2019-12-27 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| EP3050557A1 (en) * | 2014-05-23 | 2016-08-03 | Ares Trading S.A. | Liquid pharmaceutical composition |
| AR103544A1 (es) | 2015-01-28 | 2017-05-17 | Mabxience S A | FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a |
-
2015
- 2015-02-18 US US15/301,421 patent/US10688187B2/en not_active Expired - Fee Related
- 2015-02-18 WO PCT/IN2015/000092 patent/WO2015151115A1/en not_active Ceased
- 2015-02-18 EP EP15774333.7A patent/EP3125928A4/en not_active Withdrawn
- 2015-02-18 IN IN1248MU2014 patent/IN2014MU01248A/en unknown
- 2015-02-18 CA CA2944330A patent/CA2944330A1/en not_active Abandoned
-
2020
- 2020-06-05 US US16/894,196 patent/US20200405864A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| EP3125928A1 (en) | 2017-02-08 |
| IN2014MU01248A (OSRAM) | 2015-10-09 |
| US10688187B2 (en) | 2020-06-23 |
| US20200405864A1 (en) | 2020-12-31 |
| WO2015151115A1 (en) | 2015-10-08 |
| EP3125928A4 (en) | 2017-11-29 |
| US20170106090A1 (en) | 2017-04-20 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US20200405864A1 (en) | Liquid pharmaceutical composition of adalimumab | |
| AU2013255413C1 (en) | Pharmaceutical formulations of TNF-alpha antibodies | |
| CN102458469B (zh) | 人抗TNF-α抗体的稳定高蛋白质浓度制剂 | |
| CN103998060B (zh) | 使用糖与多元醇的结合物稳定的依那西普制剂 | |
| EP2568960B1 (en) | Liquid formulation of polypeptides containing an fc domain of an immunoglobulin | |
| CN106061468B (zh) | 包含TNFR和Fc区的融合蛋白的液体制剂 | |
| JP2023018090A (ja) | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 | |
| EP3139960B1 (en) | Liquid formulation comprising gm-csf neutralizing compound | |
| TW201540322A (zh) | 依那西普之安定的液體調配劑 | |
| KR102106914B1 (ko) | Gm-csf를 중화하는 화합물을 포함하는 액체 제제 | |
| JP2018535242A (ja) | 高濃度のタンパク質ベースの治療剤を含有する医薬組成物中の非晶質安定化化合物としてのアミノ酸と糖との最適比 | |
| US10918698B2 (en) | Lyophilized pharmaceutical composition of Fc-peptide fusion protein | |
| AU2021250949A1 (en) | Liquid Pharmaceutical Composition | |
| JP2022551622A (ja) | インテグリン抗体の安定な製剤 | |
| CN110621302A (zh) | 结合肌生成抑制蛋白的纤连蛋白基支架结构域蛋白质的稳定制剂 | |
| WO2018124948A1 (ru) | ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα | |
| CN110536698B (zh) | 重组单克隆抗TNFα抗体的水性药用组合物 | |
| CA2946230C (en) | Liquid formulation comprising gm-csf neutralizing compound | |
| HK40010132B (zh) | 重组单克隆抗TNF α 抗体的水性药用组合物 | |
| HK1204921B (en) | Stable liquid formulation of etanercept |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20191129 |
|
| FZDE | Discontinued |
Effective date: 20220208 |