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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- 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
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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
- 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
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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
- A61K39/39591—Stabilisation, fragmentation
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- 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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- 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
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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
- 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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- 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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- 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
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- C07K2317/524—CH2 domain
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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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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 | |
| PCT/US2016/047506 WO2017031288A1 (en) | 2015-08-19 | 2016-08-18 | Stable anti-ifnar1 formulation |
| EP16837818.0A EP3337502B1 (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 (25)
| Country | Link |
|---|---|
| US (1) | US10125195B2 (hr) |
| EP (3) | EP3337502B1 (hr) |
| JP (4) | JP6720293B2 (hr) |
| KR (4) | KR20240090616A (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) | HUE061985T2 (hr) |
| IL (1) | IL257279B2 (hr) |
| LT (2) | LT3337502T (hr) |
| PL (2) | PL3769781T3 (hr) |
| PT (2) | PT3337502T (hr) |
| RS (2) | RS60773B1 (hr) |
| RU (1) | RU2731737C2 (hr) |
| SG (1) | SG10202106970XA (hr) |
| SI (2) | SI3769781T1 (hr) |
| SM (2) | SMT202300176T1 (hr) |
| WO (1) | WO2017031288A1 (hr) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10125195B2 (en) | 2015-08-19 | 2018-11-13 | Astrazeneca Ab | Stable anti-IFNAR1 formulation |
| 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 |
| AU2020225202B2 (en) | 2019-02-18 | 2023-10-26 | Eli Lilly And Company | Therapeutic antibody formulation |
| 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 |
| DK4058060T3 (da) * | 2019-11-11 | 2025-03-17 | Astrazeneca Ab | Type i-interferon-hæmning ved systemisk lupus erythematosus |
| CN115667309A (zh) * | 2020-05-29 | 2023-01-31 | 阿斯利康(瑞典)有限公司 | 使用i型干扰素信号传导的抑制剂治疗心血管代谢疾病 |
| AU2021295605A1 (en) | 2020-06-25 | 2023-02-16 | Eli Lilly And Company | Prevention of axonal damage using antibody binding to amyloid BETA 1-42 |
| 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 |
| JP2024518735A (ja) * | 2021-04-23 | 2024-05-02 | アストラゼネカ・アクチエボラーグ | 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療 |
| CA3216390A1 (en) * | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Treatment of cutaneous lupus erythematous |
| CN117157099A (zh) * | 2021-04-23 | 2023-12-01 | 阿斯利康(瑞典)有限公司 | 用于皮下注射的抗ifnar1给药方案 |
| CA3216387A1 (en) | 2021-04-23 | 2022-10-27 | Astrazeneca Ab | Anti-ifnar1 dosing regime for subcutaneous injection |
| WO2022238479A1 (en) * | 2021-05-12 | 2022-11-17 | Astrazeneca Ab | Inhibitor of type 1 interferon receptor steroid sparing in systemic lupus erythematosus patients |
| 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 |
| 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 |
| AU2022317215A1 (en) | 2021-07-27 | 2024-02-29 | Astrazeneca Ab | Treatment of lupus |
| AU2022359684A1 (en) * | 2021-10-04 | 2024-05-09 | Astrazeneca Ab | Treatment of lupus |
| EP4422674A1 (en) * | 2021-10-29 | 2024-09-04 | Intas Pharmaceuticals Ltd. | Stable lyophilized formulation of an anti-alpha 4beta7 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 |
| IN202221038828A (hr) * | 2022-07-06 | 2024-01-12 | ||
| WO2024079241A1 (en) | 2022-10-13 | 2024-04-18 | Astrazeneca Ab | Treatment of lupus |
| WO2024241156A1 (en) | 2023-05-19 | 2024-11-28 | Astrazeneca Ab | Treatment of lupus |
| WO2025022280A1 (en) | 2023-07-21 | 2025-01-30 | Astrazeneca Ab | Treatment of neurodegenerative diseases |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN101001878B (zh) * | 2004-06-21 | 2012-09-26 | 米德列斯公司 | 干扰素α受体1抗体及其用途 |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| CN101553504A (zh) | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
| CA2692165A1 (en) | 2007-06-25 | 2008-12-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
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| US10125195B2 (en) | 2015-08-19 | 2018-11-13 | Astrazeneca Ab | Stable anti-IFNAR1 formulation |
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