DK3237001T3 - Farmaceutiske produkter og stabile flydende sammensætninger af il-17-antistoffer - Google Patents
Farmaceutiske produkter og stabile flydende sammensætninger af il-17-antistoffer Download PDFInfo
- Publication number
- DK3237001T3 DK3237001T3 DK15823805.5T DK15823805T DK3237001T3 DK 3237001 T3 DK3237001 T3 DK 3237001T3 DK 15823805 T DK15823805 T DK 15823805T DK 3237001 T3 DK3237001 T3 DK 3237001T3
- Authority
- DK
- Denmark
- Prior art keywords
- antibodies
- liquid compositions
- pharmaceutical products
- stable liquid
- stable
- Prior art date
Links
- 239000007788 liquid Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 title 1
- 229940127557 pharmaceutical product Drugs 0.000 title 1
Classifications
-
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K9/08—Solutions
-
- 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
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
-
- 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]
-
- 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
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Transplantation (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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462095210P | 2014-12-22 | 2014-12-22 | |
| PCT/IB2015/059836 WO2016103153A1 (en) | 2014-12-22 | 2015-12-21 | Pharmaceutical products and stable liquid compositions of il-17 antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3237001T3 true DK3237001T3 (da) | 2024-04-15 |
Family
ID=55135471
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15823805.5T DK3237001T3 (da) | 2014-12-22 | 2015-12-21 | Farmaceutiske produkter og stabile flydende sammensætninger af il-17-antistoffer |
Country Status (27)
| Country | Link |
|---|---|
| US (1) | US11801300B2 (da) |
| EP (1) | EP3237001B1 (da) |
| JP (4) | JP6770974B2 (da) |
| KR (3) | KR20230173742A (da) |
| CN (5) | CN114452381A (da) |
| AR (1) | AR103173A1 (da) |
| AU (1) | AU2015370522B2 (da) |
| BR (1) | BR112017013240A2 (da) |
| CA (1) | CA2971800A1 (da) |
| CL (1) | CL2017001638A1 (da) |
| CO (1) | CO2017005950A2 (da) |
| DK (1) | DK3237001T3 (da) |
| EA (1) | EA033824B1 (da) |
| EC (1) | ECSP17047155A (da) |
| FI (1) | FI3237001T3 (da) |
| HR (1) | HRP20240253T1 (da) |
| IL (3) | IL287328B1 (da) |
| LT (1) | LT3237001T (da) |
| MX (1) | MX2017008412A (da) |
| PE (1) | PE20170952A1 (da) |
| PH (1) | PH12017500966A1 (da) |
| PT (1) | PT3237001T (da) |
| RS (1) | RS65387B1 (da) |
| SG (1) | SG11201703828VA (da) |
| TN (1) | TN2017000181A1 (da) |
| TW (1) | TW201641104A (da) |
| WO (1) | WO2016103153A1 (da) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR103172A1 (es) * | 2014-12-22 | 2017-04-19 | Novartis Ag | Reducción selectiva de residuos de cisteina en anticuerpos il-17 |
| CN109476733A (zh) * | 2016-07-19 | 2019-03-15 | 诺华股份有限公司 | 使用il-17拮抗剂治疗新发斑块型银屑病的方法 |
| TW202348250A (zh) * | 2017-07-24 | 2023-12-16 | 美商再生元醫藥公司 | 穩定化之抗體組合物及其製法 |
| JP2021501752A (ja) * | 2017-11-02 | 2021-01-21 | ノバルティス アーゲー | インターロイキン−１７（ｉｌ−１７）アンタゴニストを使用して腱障害を治療する方法 |
| GB201719447D0 (en) * | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
| CN109350740B (zh) * | 2017-11-30 | 2023-06-20 | 百奥泰生物制药股份有限公司 | 一种治疗il-6相关疾病的人源化抗体的液体制剂 |
| CN111303283A (zh) * | 2018-12-12 | 2020-06-19 | 上海君实生物医药科技股份有限公司 | 抗il-17a抗体及其应用 |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| RU2754760C2 (ru) * | 2019-04-02 | 2021-09-07 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция анти-il17a антитела и ее применение |
| 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 |
| CN110124030A (zh) * | 2019-06-10 | 2019-08-16 | 通化东宝生物科技有限公司 | 一种苏金单抗注射液及其制备方法 |
| CN114981302A (zh) | 2019-09-20 | 2022-08-30 | 诺华股份有限公司 | 使用白细胞介素-17(il-17)拮抗剂治疗自身免疫性疾病的方法 |
| CN110585430B (zh) * | 2019-09-29 | 2023-09-08 | 华博生物医药技术（上海）有限公司 | 一种人源化抗人il-17a单克隆抗体的药物组合物 |
| AU2020386669A1 (en) | 2019-11-19 | 2022-06-02 | Novartis Ag | Methods of treating Lupus Nephritis using interleukin-17 (IL-17) antagonists |
| CN112915201B (zh) * | 2019-12-06 | 2023-06-27 | 珠海市丽珠单抗生物技术有限公司 | 包含抗il-17抗体的液体制剂 |
| CN117529506A (zh) * | 2021-06-11 | 2024-02-06 | 海南先声药业有限公司 | 抗人il-17抗体和taci的双功能融合蛋白分子 |
| CN113999300B (zh) * | 2021-12-13 | 2022-09-13 | 青岛润达生物科技有限公司 | 一种高效提取卵黄抗体的复合沉降剂及方法 |
| CN114452383B (zh) * | 2022-02-17 | 2023-06-06 | 中国中医科学院中药研究所 | 司库奇尤单抗在治疗糖尿病溃疡中的用途 |
| CN117883376A (zh) * | 2024-03-14 | 2024-04-16 | 北京四环生物制药有限公司 | 含重组人白细胞介素-2的药物制剂及其制备方法 |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5272135A (en) | 1991-03-01 | 1993-12-21 | Chiron Ophthalmics, Inc. | Method for the stabilization of methionine-containing polypeptides |
| HUP0203133A3 (en) * | 1999-10-04 | 2005-07-28 | Chiron Corp Emeryville | Stabilized liquid polypeptide-containing pharmaceutical compositions |
| US20030104996A1 (en) * | 2001-08-30 | 2003-06-05 | Tiansheng Li | L-methionine as a stabilizer for NESP/EPO in HSA-free formulations |
| KR100913714B1 (ko) | 2001-11-08 | 2009-08-24 | 패시트 바이오테크 코포레이션 | Ｉｇｇ 항체의 안정한 액상 약학 제형물 |
| GB0417487D0 (en) | 2004-08-05 | 2004-09-08 | Novartis Ag | Organic compound |
| WO2006096490A2 (en) * | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | ANTI-MAdCAM ANTIBODY COMPOSITIONS |
| US7592429B2 (en) | 2005-05-03 | 2009-09-22 | Ucb Sa | Sclerostin-binding antibody |
| WO2007117749A2 (en) | 2006-01-31 | 2007-10-18 | Novartis Ag | Il-17 antagonistic antibodies fpr treating cancer |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| WO2010100179A2 (en) | 2009-03-05 | 2010-09-10 | Novartis Ag | Self-forming gel system for sustained drug delivery |
| CA2765220A1 (en) * | 2009-07-14 | 2011-01-20 | Biogen Idec Ma Inc. | Methods for inhibiting yellow color and peroxide formation in a composition |
| EP2361636A1 (en) * | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| WO2012028683A1 (en) | 2010-09-02 | 2012-03-08 | Novartis Ag | Antibody gel system for sustained drug delivery |
| EP4137514A1 (en) * | 2010-10-08 | 2023-02-22 | Novartis AG | Methods of treating psoriasis using il-17 antagonists |
| KR20180129991A (ko) * | 2010-11-05 | 2018-12-05 | 노파르티스 아게 | Ｉｌ-１７ 길항제를 사용한 류마티스성 관절염의 치료 방법 |
| CA2856252A1 (en) * | 2011-11-21 | 2013-05-30 | Novartis Ag | Methods of treating psoriatic arthritis (psa) using il-17 antagonists and psa response or non-response alleles |
| SI2822590T1 (sl) * | 2012-03-07 | 2017-01-31 | Eli Lilly And Company | Formulacije s protitelesi proti IL-17 |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
-
2015
- 2015-12-18 AR ARP150104193A patent/AR103173A1/es unknown
- 2015-12-21 LT LTEPPCT/IB2015/059836T patent/LT3237001T/lt unknown
- 2015-12-21 AU AU2015370522A patent/AU2015370522B2/en active Active
- 2015-12-21 IL IL287328A patent/IL287328B1/en unknown
- 2015-12-21 EP EP15823805.5A patent/EP3237001B1/en active Active
- 2015-12-21 IL IL310604A patent/IL310604A/en unknown
- 2015-12-21 CN CN202111362326.5A patent/CN114452381A/zh active Pending
- 2015-12-21 HR HRP20240253TT patent/HRP20240253T1/hr unknown
- 2015-12-21 SG SG11201703828VA patent/SG11201703828VA/en unknown
- 2015-12-21 JP JP2017551391A patent/JP6770974B2/ja active Active
- 2015-12-21 RS RS20240422A patent/RS65387B1/sr unknown
- 2015-12-21 CN CN202111362173.4A patent/CN114452380A/zh active Pending
- 2015-12-21 TN TN2017000181A patent/TN2017000181A1/en unknown
- 2015-12-21 PT PT158238055T patent/PT3237001T/pt unknown
- 2015-12-21 CN CN202111362275.6A patent/CN113876947A/zh active Pending
- 2015-12-21 CN CN201580076632.9A patent/CN107257692B/zh active Active
- 2015-12-21 KR KR1020237043038A patent/KR20230173742A/ko not_active Application Discontinuation
- 2015-12-21 KR KR1020177016756A patent/KR102506173B1/ko active IP Right Grant
- 2015-12-21 FI FIEP15823805.5T patent/FI3237001T3/fi active
- 2015-12-21 EA EA201791422A patent/EA033824B1/ru not_active IP Right Cessation
- 2015-12-21 CN CN202111364411.5A patent/CN113855800A/zh active Pending
- 2015-12-21 TW TW104143009A patent/TW201641104A/zh unknown
- 2015-12-21 PE PE2017001096A patent/PE20170952A1/es not_active Application Discontinuation
- 2015-12-21 KR KR1020237007135A patent/KR102614921B1/ko active IP Right Grant
- 2015-12-21 DK DK15823805.5T patent/DK3237001T3/da active
- 2015-12-21 MX MX2017008412A patent/MX2017008412A/es unknown
- 2015-12-21 US US15/538,257 patent/US11801300B2/en active Active
- 2015-12-21 WO PCT/IB2015/059836 patent/WO2016103153A1/en active Application Filing
- 2015-12-21 CA CA2971800A patent/CA2971800A1/en active Pending
- 2015-12-21 BR BR112017013240A patent/BR112017013240A2/pt not_active Application Discontinuation
-
2017
- 2017-05-07 IL IL252141A patent/IL252141B/en unknown
- 2017-05-25 PH PH12017500966A patent/PH12017500966A1/en unknown
- 2017-06-15 CO CONC2017/0005950A patent/CO2017005950A2/es unknown
- 2017-06-21 CL CL2017001638A patent/CL2017001638A1/es unknown
- 2017-07-20 EC ECIEPI201747155A patent/ECSP17047155A/es unknown
-
2019
- 2019-08-16 JP JP2019149368A patent/JP6878524B2/ja active Active
-
2021
- 2021-04-27 JP JP2021074603A patent/JP2021119165A/ja not_active Withdrawn
-
2023
- 2023-06-09 JP JP2023095510A patent/JP2023113906A/ja active Pending
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