HRP20201297T1 - Stabilna formulacija anti-ifnar1 - Google Patents
Stabilna formulacija anti-ifnar1 Download PDFInfo
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- HRP20201297T1 HRP20201297T1 HRP20201297TT HRP20201297T HRP20201297T1 HR P20201297 T1 HRP20201297 T1 HR P20201297T1 HR P20201297T T HRP20201297T T HR P20201297TT HR P20201297 T HRP20201297 T HR P20201297T HR P20201297 T1 HRP20201297 T1 HR P20201297T1
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- Prior art keywords
- antibody
- formulation
- formulation according
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- antibody formulation
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- 238000009472 formulation Methods 0.000 title claims 27
- 239000000203 mixture Substances 0.000 title claims 27
- DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.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 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims 3
- QZNNVYOVQUKYSC-JEDNCBNOSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride Chemical compound Cl.OC(=O)[C@@H](N)CC1=CN=CN1 QZNNVYOVQUKYSC-JEDNCBNOSA-N 0.000 claims 3
- 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 claims 3
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 3
- 229950010117 anifrolumab Drugs 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 229960003646 lysine Drugs 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 229940074409 trehalose dihydrate Drugs 0.000 claims 3
- 101000852870 Homo sapiens Interferon alpha/beta receptor 1 Proteins 0.000 claims 1
- 102100036714 Interferon alpha/beta receptor 1 Human genes 0.000 claims 1
- 238000004220 aggregation Methods 0.000 claims 1
- 230000002776 aggregation Effects 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000013467 fragmentation Methods 0.000 claims 1
- 238000006062 fragmentation reaction Methods 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 229920001184 polypeptide Polymers 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
Classifications
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- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
-
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A61P17/06—Antipsoriatics
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- A61P19/00—Drugs for skeletal disorders
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- 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
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
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- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P21/00—Preparation of peptides or proteins
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- Animal Behavior & Ethology (AREA)
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- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Diabetes (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Rheumatology (AREA)
- Wood Science & Technology (AREA)
- Physical Education & Sports Medicine (AREA)
- Zoology (AREA)
- Endocrinology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Hematology (AREA)
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- Emergency Medicine (AREA)
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Claims (15)
1. Formulacija protutijela koja sadrži:
a. 100 mg/mL do 200 mg/mL anifrolumaba;
b. 40 mM do 60 mM lizin HCl;
c. 100 mM do 160 mM trehaloza dihidrata;
d. 0.02% do 0.1% polisorbata 80;
e. 15 mM do 35 mM histidina/histidin HCl,
naznačena time što formulacija ima pH od oko 5.5 do oko 6.5.
2. Formulacija protutijela prema patentnom zahtjevu 1 koja sadrži:
a. 145 mg/mL do 155 mg/mL anifrolumaba ili njegovog ulomka koji veže antigen;
b. 45 mM do 55 mM lizin HCl;
c. 120 mM do 140 mM trehaloza dihidrata;
d. 0.04% do 0.08% polisorbata 80;
e. 20 mM do 30 mM histidina/histidin HCl,
naznačena time što formulacija ima pH od oko 5.8 do 6.1.
3. Formulacija protutijela prema patentnom zahtjevu 2 koja sadrži:
a. 150 mg/mL anifrolumab;
b. 50 mM lizin HCl;
c. 130 mM trehaloza dihidrata;
d. 0.05% polisorbata 80;
e. 25 mM histidina/histidin HCl,
naznačena time što formulacija ima pH od 5.9.
4. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time što navedena formulacija ima viskoznost jednaku ili manju od 20 mPas pri 25° C.
5. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time što je navedena formulacija stabilna nakon skladištenja na oko 40° C tijekom 1 do 24 mjeseca.
6. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time što je navedena formulacija stabilna nakon skladištenja na oko 40° C tijekom 1 do 18 mjeseci.
7. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 6, naznačena time što navedena formulacija ima manje od 700 čestica po većih od ili jednake veličine 10 µm nakon skladištenja na oko 40° C tijekom 18 mjeseci.
8. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time što navedena formulacija ima brzinu gubitka čistoće pri 40°C od 3 do 5% mjesečno tijekom 12 mjeseci kako je određeno pomoću HP-SEC.
9. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time što navedena formulacija ima stopu fragmentacije od 2.0 do 4.0 posto mjesečno tijekom 12 mjeseci kako je određeno pomoću HP-SEC.
10. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time što navedena formulacija ima brzinu agregacije 0.5 do 2.5% mjesečno tijekom 12 mjeseci kako je određeno pomoću HP-SEC.
11. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 10, naznačena time što se 1% do 6% protutijela razgrađuje, denaturira, agregira ili nije smotano mjesečno nakon skladištenja na oko 5° C tijekom 1 do 24 mjeseca.
12. Formulacija protutijela prema bilo kojem od patentnih zahtjeva 1 do 11, naznačena time što protutijelo pohranjeno na oko 5° C tijekom najmanje 6 mjeseci zadržava najmanje 80% sposobnosti vezanja na IFNAR polipeptid u usporedbi s referentnim protutijelom koje nije pohranjeno.
13. Formulacija protutijela prema patentnom zahtjevu 12, naznačena time što je navedena formulacija pogodna za intravensku, potkožnu ili intramuskularnu primjenu.
14. Zatvoreni spremnik naznačen time što sadrži formulaciju protutijela prema bilo kojem od patentnih zahtjeva 1 do 13.
15. Farmaceutski jedinični oblik doziranja pogodan za parenteralnu primjenu čovjeku naznačen time što sadrži formulaciju protutijela prema bilo kojem od patentnih zahtjeva 1 do 14 u prikladnom spremniku.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562207164P | 2015-08-19 | 2015-08-19 | |
EP16837818.0A EP3337502B1 (en) | 2015-08-19 | 2016-08-18 | Stable anti-ifnar1 formulation |
PCT/US2016/047506 WO2017031288A1 (en) | 2015-08-19 | 2016-08-18 | Stable anti-ifnar1 formulation |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20201297T1 true HRP20201297T1 (hr) | 2020-11-27 |
Family
ID=58052002
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230463TT HRP20230463T1 (hr) | 2015-08-19 | 2016-08-18 | Stabilna anti-ifnar1 formulacija |
HRP20201297TT HRP20201297T1 (hr) | 2015-08-19 | 2020-08-19 | Stabilna formulacija anti-ifnar1 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230463TT HRP20230463T1 (hr) | 2015-08-19 | 2016-08-18 | Stabilna anti-ifnar1 formulacija |
Country Status (24)
Country | Link |
---|---|
US (1) | US10125195B2 (hr) |
EP (3) | EP4233892A3 (hr) |
JP (3) | JP6720293B2 (hr) |
KR (3) | KR102168005B1 (hr) |
CN (1) | CN107921109A (hr) |
AU (3) | AU2016308262C1 (hr) |
BR (1) | BR112018002196A8 (hr) |
CA (1) | CA2995222C (hr) |
CY (2) | CY1123657T1 (hr) |
DK (2) | DK3337502T3 (hr) |
ES (2) | ES2818229T3 (hr) |
FI (1) | FI3769781T3 (hr) |
HK (1) | HK1256195A1 (hr) |
HR (2) | HRP20230463T1 (hr) |
HU (2) | HUE051862T2 (hr) |
IL (1) | IL257279B2 (hr) |
LT (2) | LT3769781T (hr) |
PL (2) | PL3337502T3 (hr) |
PT (2) | PT3769781T (hr) |
RS (2) | RS60773B1 (hr) |
RU (1) | RU2731737C2 (hr) |
SG (1) | SG10202106970XA (hr) |
SI (2) | SI3769781T1 (hr) |
WO (1) | WO2017031288A1 (hr) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
HRP20230463T1 (hr) | 2015-08-19 | 2023-07-21 | Astrazeneca Ab | Stabilna anti-ifnar1 formulacija |
GB201719447D0 (en) | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
US20200061015A1 (en) * | 2018-08-23 | 2020-02-27 | Janssen Biotech, Inc. | Lipase Degradation Resistant Surfactants for Use in Large Molecule Therapeutic Formulations |
BR112021015034A2 (pt) | 2019-02-18 | 2021-10-05 | Eli Lilly And Company | Formulação de anticorpo terapêutico |
CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
KR20220099985A (ko) * | 2019-11-11 | 2022-07-14 | 아스트라제네카 아베 | 전신성 홍반성 루푸스에서 i형 인터페론 억제 |
CA3183611A1 (en) | 2020-05-29 | 2021-12-02 | Astrazeneca Ab | Treatment of cardiometabolic disease |
TW202216188A (zh) | 2020-06-25 | 2022-05-01 | 英商梅迪繆思有限公司 | 軸突損傷之預防 |
TW202237647A (zh) | 2020-10-08 | 2022-10-01 | 瑞典商阿斯特捷利康公司 | 狼瘡發作之治療 |
ES2963757T3 (es) | 2021-04-23 | 2024-04-01 | Astrazeneca Ab | Régimen de dosificación de anti-ifnar1 para inyección subcutánea |
CA3216395A1 (en) * | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Treatment of lupus nephritis with anti-type i inf receptor antibody anifrolumab |
BR112023021868A2 (pt) * | 2021-04-23 | 2023-12-19 | Astrazeneca Ab | Tratamento de lúpus eritematoso cutâneo |
CA3219401A1 (en) * | 2021-05-12 | 2022-11-17 | Astrazeneca Ab | Inhibitor of type 1 interferon receptor steroid sparing in systemic lupus erythematosus patients |
CN113521276B (zh) * | 2021-07-13 | 2022-04-12 | 江苏荃信生物医药股份有限公司 | 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂 |
CN113527490B (zh) * | 2021-07-13 | 2022-03-01 | 江苏荃信生物医药股份有限公司 | 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法 |
WO2023284073A1 (zh) * | 2021-07-13 | 2023-01-19 | 江苏荃信生物医药股份有限公司 | 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂 |
KR20240038773A (ko) | 2021-07-27 | 2024-03-25 | 아스트라제네카 아베 | 루푸스의 치료 |
AU2022359684A1 (en) * | 2021-10-04 | 2024-05-09 | Astrazeneca Ab | Treatment of lupus |
WO2023073469A1 (en) * | 2021-10-29 | 2023-05-04 | Intas Pharmaceuticals Ltd. | STABLE LYOPHILIZED FORMULATION OF AN ANTI-α4ß7 ANTIBODY |
TW202337497A (zh) * | 2022-02-18 | 2023-10-01 | 中國大陸商重慶明道浩悅生物科技有限公司 | 鼻內調配物及抗sars-cov-2棘蛋白抗體 |
WO2024009205A1 (en) * | 2022-07-06 | 2024-01-11 | Intas Pharmaceuticals Ltd. | STABLE LIQUID FORMULATION OF AN ANTI-Α4ß7 ANTIBODY |
WO2024079241A1 (en) | 2022-10-13 | 2024-04-18 | Astrazeneca Ab | Treatment of lupus |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
US6713609B1 (en) * | 1996-07-16 | 2004-03-30 | Genentech, Inc. | Monoclonal antibodies to type I interferon receptor |
ES2526194T3 (es) * | 2004-06-21 | 2015-01-08 | E. R. Squibb & Sons, L.L.C. | Anticuerpos del receptor 1 de interferón alfa, y sus usos |
JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
TW200831133A (en) | 2006-12-11 | 2008-08-01 | Hoffmann La Roche | Mab Abeta lyophylized formulation |
JP5513380B2 (ja) | 2007-06-25 | 2014-06-04 | アムジエン・インコーポレーテツド | 肝細胞増殖因子に対する特異的結合剤の組成物 |
EP2225275A4 (en) * | 2007-11-28 | 2013-04-03 | Medimmune Llc | PROTEIN FORMULATION |
CA2713981C (en) * | 2008-02-08 | 2016-11-01 | Medimmune, Llc | Anti-ifnar1 antibodies with reduced fc ligand affinity |
BRPI0921845A2 (pt) | 2008-11-12 | 2019-09-17 | Medimmune Llc | formulação aquosa estéril estável, forma de dosagem unitária farmacêutica, seringa pré-carregada, e, métodos para tratar uma doença ou distúrbio, para tratar ou prevenir rejeição, para esgotar células t que expressam icos em um paciente humano, e para interromper arquitetura central germinal em um órgão linfóide secundário de um primata |
CA2849192C (en) | 2011-10-12 | 2019-09-24 | Ascendis Pharma Ophthalmology Division A/S | Prevention and treatment of ocular conditions |
CN104023748B (zh) | 2011-10-28 | 2018-03-02 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
BR112015008186A2 (pt) * | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
EP2997036B1 (en) * | 2013-05-15 | 2021-03-03 | Medimmune Limited | Purification of recombinantly produced polypeptides |
US20160250329A1 (en) * | 2013-10-29 | 2016-09-01 | Albumedix A/S | Antibody composition |
AU2015310879A1 (en) | 2014-09-03 | 2017-03-02 | Medimmune Limited | Stable anti-IL-4R-alpha antibody formulation |
US20180000932A1 (en) | 2014-12-31 | 2018-01-04 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
HRP20230463T1 (hr) | 2015-08-19 | 2023-07-21 | Astrazeneca Ab | Stabilna anti-ifnar1 formulacija |
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