DK2822590T3 - Il-17-antistofformulering - Google Patents
Il-17-antistofformulering Download PDFInfo
- Publication number
- DK2822590T3 DK2822590T3 DK13710214.1T DK13710214T DK2822590T3 DK 2822590 T3 DK2822590 T3 DK 2822590T3 DK 13710214 T DK13710214 T DK 13710214T DK 2822590 T3 DK2822590 T3 DK 2822590T3
- Authority
- DK
- Denmark
- Prior art keywords
- ser
- antibody
- concentration
- val
- thr
- Prior art date
Links
Classifications
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- 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
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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
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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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
-
- 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
-
- 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
-
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
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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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Rheumatology (AREA)
- Dermatology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (8)
1. Farmaceutisk formulering omfattende et anti-IL-17-antistof i en koncentration i området 80 mg/ml til 150 mg/ml, citratbuffer i en koncentration på 20 mM, natriumchlorid i en koncentration på 200 mM, polysorbat-80 i en koncentration i området 0,02 % (w/v) til 0,03 % (w/v) og pH på 5,7, hvor anti-IL-17-antistoffet omfatter et antistof med en let kæde (LC) og en tung kæde (HC), hvor nævnte LC er aminosyresekvensen med SEQ ID NO: 4, og nævnte HC er aminosyresekvensen med SEQ ID NO: 5.
2. Farmacetisk formulering ifølge krav 1, hvor koncentrationen af anti-IL-17-antistoffet er 80 mg/ml.
3. Farmaceutisk formulering ifølge krav 1 eller krav 2, hvor koncentrationen af polysorbat-80 er 0,03 % (w/v).
4. Farmaceutisk formulering ifølge et hvilket som helst af kravene 1 til 3, hvor formuleringen er en farmaceutisk anti-IL-17-antistofformulering.
5. Farmaceutisk formulering ifølge et hvilket som helst af kravene 1 til 4, omfattende et anti-IL-17-antistof i en koncentration på 80 mg/ml, citratbuffer i en koncentration på 20 mM, natriumchlorid i en koncentration på 200 mM, polysorbat-80 i en koncentration på 0,03% og pH på 5,7, hvor anti-IL-17-antistoffet omfatter et antistof omfattende to lette kæder (LC'er) og to tunge kæder (HC'er), hvor hver LC er aminosyresekvensen med SEQ ID NO: 4, og hver HC er aminosyresekvensen med SEQ ID NO: 5.
6. Formulering ifølge et hvilket som helst af de foregående krav, hvor anti-IL-17-antistoffet omfatter et antistof omfattende to lette kæder (LC'er) og to tunge kæder (HC'er), hvor hver LC er aminosyresekvensen med SEQ ID NO: 4, og hver HC er aminosyresekvensen med SEQ ID NO: 5.
7. Farmaceutisk formulering ifølge et hvilket som helst af de foregående krav til anvendelse i terapi.
8. Farmaceutisk formulering ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandling af reumatoid artritis, psoriasis, ankyloserende spondylitis, psoriasis artritis eller myelomatose.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261607671P | 2012-03-07 | 2012-03-07 | |
| PCT/US2013/028516 WO2013134052A1 (en) | 2012-03-07 | 2013-03-01 | Il-17 antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2822590T3 true DK2822590T3 (da) | 2017-01-23 |
Family
ID=47892018
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13710214.1T DK2822590T3 (da) | 2012-03-07 | 2013-03-01 | Il-17-antistofformulering |
Country Status (34)
| Country | Link |
|---|---|
| US (3) | US9376491B2 (da) |
| EP (2) | EP2822590B1 (da) |
| JP (1) | JP6117252B2 (da) |
| KR (1) | KR101653082B1 (da) |
| CN (1) | CN104159612B (da) |
| AU (1) | AU2013230490B2 (da) |
| BR (1) | BR112014021308B1 (da) |
| CA (1) | CA2866128C (da) |
| CL (1) | CL2014002204A1 (da) |
| CY (1) | CY1118393T1 (da) |
| DK (1) | DK2822590T3 (da) |
| EA (1) | EA030742B1 (da) |
| EC (1) | ECSP14017562A (da) |
| ES (1) | ES2610707T3 (da) |
| HR (1) | HRP20161604T1 (da) |
| HU (1) | HUE031290T2 (da) |
| IL (1) | IL234053B (da) |
| LT (1) | LT2822590T (da) |
| MA (1) | MA37317B1 (da) |
| ME (1) | ME02565B (da) |
| MX (1) | MX362191B (da) |
| MY (1) | MY167233A (da) |
| NZ (1) | NZ627648A (da) |
| PE (1) | PE20142275A1 (da) |
| PH (1) | PH12014501985B1 (da) |
| PL (1) | PL2822590T3 (da) |
| PT (1) | PT2822590T (da) |
| RS (1) | RS55417B1 (da) |
| SG (1) | SG11201404491XA (da) |
| SI (1) | SI2822590T1 (da) |
| TN (1) | TN2014000341A1 (da) |
| UA (1) | UA114620C2 (da) |
| WO (1) | WO2013134052A1 (da) |
| ZA (1) | ZA201405654B (da) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR103173A1 (es) * | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| CA3063324A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| WO2019027828A1 (en) * | 2017-08-04 | 2019-02-07 | Eli Lilly And Company | DOSAGE SCHEME OF ANTI-IL-17 ANTIBODIES |
| CN111032691A (zh) * | 2017-08-23 | 2020-04-17 | 伊莱利利公司 | 生殖器银屑病的治疗 |
| MX2017016884A (es) * | 2017-12-19 | 2019-06-20 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina anti-tnfa. |
| EP3888678A4 (en) * | 2018-11-29 | 2022-02-16 | Harbour Biomed Therapeutics Limited | PREPARATION OF AN ANTI-PD-L1 ANTIBODY |
| CN120241997A (zh) * | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| WO2022135395A1 (zh) * | 2020-12-22 | 2022-06-30 | 百奥泰生物制药股份有限公司 | 稳定的抗体制剂及其制备方法和应用 |
| CN119147687B (zh) * | 2024-11-11 | 2025-03-14 | 智翔（上海）医药科技有限公司 | 用于抗白介素17a抗体质量检测的方法 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2672221T3 (es) * | 2005-12-13 | 2018-06-13 | Eli Lilly And Company | Anticuerpos anti IL-17 |
| JP5410985B2 (ja) * | 2006-12-05 | 2014-02-05 | クルセル ホランド ベー ヴェー | 液体抗狂犬病抗体製剤 |
| WO2011088120A1 (en) * | 2010-01-15 | 2011-07-21 | Amgen Inc. | Antibody formulation and therapeutic regimens |
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2013
- 2013-03-01 SI SI201330364A patent/SI2822590T1/sl unknown
- 2013-03-01 KR KR1020147024733A patent/KR101653082B1/ko active Active
- 2013-03-01 ES ES13710214.1T patent/ES2610707T3/es active Active
- 2013-03-01 MX MX2014010710A patent/MX362191B/es active IP Right Grant
- 2013-03-01 EA EA201491471A patent/EA030742B1/ru not_active IP Right Cessation
- 2013-03-01 UA UAA201409450A patent/UA114620C2/uk unknown
- 2013-03-01 NZ NZ627648A patent/NZ627648A/en unknown
- 2013-03-01 HR HRP20161604TT patent/HRP20161604T1/hr unknown
- 2013-03-01 CN CN201380012452.5A patent/CN104159612B/zh active Active
- 2013-03-01 WO PCT/US2013/028516 patent/WO2013134052A1/en not_active Ceased
- 2013-03-01 RS RS20160994A patent/RS55417B1/sr unknown
- 2013-03-01 US US14/379,755 patent/US9376491B2/en active Active
- 2013-03-01 AU AU2013230490A patent/AU2013230490B2/en active Active
- 2013-03-01 EP EP13710214.1A patent/EP2822590B1/en active Active
- 2013-03-01 MY MYPI2014702489A patent/MY167233A/en unknown
- 2013-03-01 DK DK13710214.1T patent/DK2822590T3/da active
- 2013-03-01 CA CA2866128A patent/CA2866128C/en active Active
- 2013-03-01 EP EP16195503.4A patent/EP3156073A1/en not_active Withdrawn
- 2013-03-01 ME MEP-2016-259A patent/ME02565B/me unknown
- 2013-03-01 LT LTEP13710214.1T patent/LT2822590T/lt unknown
- 2013-03-01 JP JP2014560955A patent/JP6117252B2/ja active Active
- 2013-03-01 BR BR112014021308-9A patent/BR112014021308B1/pt active IP Right Grant
- 2013-03-01 PL PL13710214T patent/PL2822590T3/pl unknown
- 2013-03-01 PT PT137102141T patent/PT2822590T/pt unknown
- 2013-03-01 HU HUE13710214A patent/HUE031290T2/hu unknown
- 2013-03-01 PE PE2014001367A patent/PE20142275A1/es active IP Right Grant
- 2013-03-01 SG SG11201404491XA patent/SG11201404491XA/en unknown
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2014
- 2014-07-30 ZA ZA2014/05654A patent/ZA201405654B/en unknown
- 2014-08-06 TN TNP2014000341A patent/TN2014000341A1/fr unknown
- 2014-08-11 IL IL234053A patent/IL234053B/en active IP Right Grant
- 2014-08-19 CL CL2014002204A patent/CL2014002204A1/es unknown
- 2014-09-02 MA MA37317A patent/MA37317B1/fr unknown
- 2014-09-05 EC ECIEPI201417562A patent/ECSP14017562A/es unknown
- 2014-09-05 PH PH12014501985A patent/PH12014501985B1/en unknown
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2016
- 2016-06-10 US US15/178,583 patent/US9845353B2/en active Active
- 2016-12-23 CY CY20161101339T patent/CY1118393T1/el unknown
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2017
- 2017-11-10 US US15/808,939 patent/US10472416B2/en active Active
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