HRP20240253T1 - Farmaceutski proizvodi i stabilni tekući pripravci od il-17 protutijela - Google Patents
Farmaceutski proizvodi i stabilni tekući pripravci od il-17 protutijela Download PDFInfo
- Publication number
- HRP20240253T1 HRP20240253T1 HRP20240253TT HRP20240253T HRP20240253T1 HR P20240253 T1 HRP20240253 T1 HR P20240253T1 HR P20240253T T HRP20240253T T HR P20240253TT HR P20240253 T HRP20240253 T HR P20240253T HR P20240253 T1 HRP20240253 T1 HR P20240253T1
- Authority
- HR
- Croatia
- Prior art keywords
- secukinumab
- preparation
- less
- methionine
- gas space
- Prior art date
Links
- 239000000825 pharmaceutical preparation Substances 0.000 title claims 15
- 239000007788 liquid Substances 0.000 title claims 9
- 229940127557 pharmaceutical product Drugs 0.000 title claims 9
- 239000000203 mixture Substances 0.000 title 1
- 229960004540 secukinumab Drugs 0.000 claims 10
- 239000007789 gas Substances 0.000 claims 9
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 7
- 229960004452 methionine Drugs 0.000 claims 7
- 238000000034 method Methods 0.000 claims 7
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 6
- 229930182817 methionine Natural products 0.000 claims 6
- 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 claims 5
- 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 claims 5
- 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 claims 5
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 5
- 239000001301 oxygen Substances 0.000 claims 5
- 229910052760 oxygen Inorganic materials 0.000 claims 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 4
- 229920000053 polysorbate 80 Polymers 0.000 claims 4
- 229940068968 polysorbate 80 Drugs 0.000 claims 4
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 claims 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 2
- 229960002885 histidine Drugs 0.000 claims 2
- 239000011261 inert gas Substances 0.000 claims 2
- 229920001983 poloxamer Polymers 0.000 claims 2
- 229960000502 poloxamer Drugs 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 239000003381 stabilizer Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- FFEARJCKVFRZRR-SCSAIBSYSA-N D-methionine Chemical compound CSCC[C@@H](N)C(O)=O FFEARJCKVFRZRR-SCSAIBSYSA-N 0.000 claims 1
- FFEARJCKVFRZRR-UHFFFAOYSA-N L-Methionine Natural products CSCCC(N)C(O)=O FFEARJCKVFRZRR-UHFFFAOYSA-N 0.000 claims 1
- 229930195722 L-methionine Natural products 0.000 claims 1
- 229910052786 argon Inorganic materials 0.000 claims 1
- 229940090047 auto-injector Drugs 0.000 claims 1
- 238000007664 blowing Methods 0.000 claims 1
- 238000004140 cleaning Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 229910052757 nitrogen Inorganic materials 0.000 claims 1
- 230000003647 oxidation Effects 0.000 claims 1
- 238000007254 oxidation reaction Methods 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (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)
Claims (18)
1. Farmaceutski proizvod, naznačen time, što sadrži:
a. spremnik koji ima plinski prostor, gdje sadržaj kisika u plinskom prostoru iznosi manje od 12%, i
b. stabilni tekući farmaceutski pripravak koji ima pH od 5,2 do 6,2, smješten unutar navedenog spremnika, gdje spomenuti pripravak sadrži:
(i) 20 mg/ml do 175 mg/ml sekukinumaba;
(ii) 2,5 do 20 mM L-metionina; i
(iii) neionski stabilizator, surfaktant odabran od polisorbata i poloksamera, te histidinski pufer.
2. Farmaceutski proizvod prema patentnom zahtjevu 1, naznačen time, što koncentracija metionina iznosi 2,5 mM, 5 mM, 10 mM ili 20 mM.
3. Farmaceutski proizvod prema bilo kojem od gore navedenih patentnih zahtjeva, naznačen time, što sadržaj kisika u plinskom prostoru iznosi manje od 10%, manje od 8%, ili manje od 6%.
4. Farmaceutski proizvod prema bilo kojem od gore navedenih patentnih zahtjeva, naznačen time, što tekući farmaceutski pripravak ima pH od 5,8.
5. Farmaceutski proizvod prema bilo kojem od gore navedenih patentnih zahtjeva, naznačen time, što koncentracija sekukinumaba iznosi 150 mg/ml.
6. Farmaceutski proizvod prema patentnom zahtjevu 1, naznačen time, što sadrži
a. spremnik koji ima plinski prostor, pri čemu sadržaj kisika u plinskom prostoru iznosi manje od 6%; i
b. stabilni tekući farmaceutski pripravak raspoređen unutar navedenog spremnika, gdje spomenuti pripravak sadrži 25 mg/ml do 150 mg/ml sekukinumaba, 10 mM do 30 mM histidina pH 5,2-6,2, 180 mM do 300 mM trehaloze, 0,01% do 0,04% polisorbata 80, i 2,5 mM do 20 mM metionina.
7. Farmaceutski proizvod prema patentnom zahtjevu 6, naznačen time, što sadrži 150 mg/ml sekukinumaba i 200 mM trehaloze.
8. Postupak za smanjenje oksidacije sekukinumaba, naznačen time, što obuhvaća:
a. pripravu stabilnog tekućeg pripravka koji ima pH od 5,2 do 6,2 i sadrži:
(i) 20 mg/ml do 175 mg/ml sekukinumaba;
(ii) 2,5 mM do 20 mM metionina; i
(iii) neionski stabilizator, surfaktant odabran od polisorbata i poloksamera, te histidinski pufer,
b. stavljanje navedenog tekućeg pripravka u spremnik koji ima plinski prostor; i
c. prilagođavanje sadržaja kisika u plinskom prostoru do manje od ili točno 12%.
9. Postupak prema patentnom zahtjevu 8, naznačen time, što se korak prilagođavanja c) izvodi putem propuhivanja i čišćenja plinskog prostora uporabom inertnog plina.
10. Postupak prema patentnom zahtjevu 9, naznačen time, što inertni plin je dušik ili argon.
11. Postupak prema patentnom zahtjevu 8 ili zahtjevu 9, naznačen time, što koncentracija metionina iznosi 2,5 mM, 5 mM, 10 mM ili 20 mM.
12. Postupak prema patentnom zahtjevu 8 ili zahtjevu 9, naznačen time, što se sadržaj kisika u plinskom prostoru podešava na manje od 10%, manje od 8%, ili manje od 6%.
13. Postupak prema patentnom zahtjevu 8 ili zahtjevu 9, naznačen time, što tekući pripravak ima pH od 5,8.
14. Postupak prema patentnom zahtjevu 8 ili zahtjevu 9, naznačen time, što koncentracija sekukinumaba iznosi 150 mg/ml.
15. Stabilni tekući farmaceutski pripravak, naznačen time, što sadrži 25 mg/ml do 150 mg/ml sekukinumaba, 10 mM do 30 mM histidina pH 5,2-6,2, 180 mM do 300 mM trehaloze, 0,01% do 0,04% polisorbata 80, i 2,5 mM do 20 mM metionina.
16. Tekući farmaceutski pripravak prema patentnom zahtjevu 15, naznačen time, što sadrži 25 mg/ml do 150 mg/ml sekukinumaba, 10 mM do 30 mM histidina pH 5,8, 200 mM do 225 mM trehaloze, 0,02% polisorbata 80, i 2,5 mM do 20 mM metionina.
17. Farmaceutski pripravak prema patentnom zahtjevu 15 ili zahtjevu 16, naznačen time, što sadrži 150 mg/ml sekukinumaba, 20 mM histidina pH 5,8, 200 mM trehaloze, 0,02% polisorbata 80, i 5 mM L-metionina.
18. Farmaceutski proizvod prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, što se spremnik bira iz skupine koju čine patrona, štrcaljka, injekcija u obliku penkale, prednapunjena šprica, autoinjektor i fijala.
Applications Claiming Priority (3)
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 |
EP15823805.5A EP3237001B1 (en) | 2014-12-22 | 2015-12-21 | Pharmaceutical products and stable liquid compositions of il-17 antibodies |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20240253T1 true HRP20240253T1 (hr) | 2024-05-10 |
Family
ID=55135471
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20240253TT HRP20240253T1 (hr) | 2014-12-22 | 2015-12-21 | Farmaceutski proizvodi i stabilni tekući pripravci od il-17 protutijela |
Country Status (29)
Country | Link |
---|---|
US (2) | US11801300B2 (hr) |
EP (2) | EP4372005A2 (hr) |
JP (4) | JP6770974B2 (hr) |
KR (3) | KR102614921B1 (hr) |
CN (5) | CN114452380A (hr) |
AR (1) | AR103173A1 (hr) |
AU (1) | AU2015370522B2 (hr) |
BR (1) | BR112017013240A2 (hr) |
CA (1) | CA2971800A1 (hr) |
CL (1) | CL2017001638A1 (hr) |
CO (1) | CO2017005950A2 (hr) |
DK (1) | DK3237001T3 (hr) |
EA (1) | EA033824B1 (hr) |
EC (1) | ECSP17047155A (hr) |
FI (1) | FI3237001T3 (hr) |
HR (1) | HRP20240253T1 (hr) |
IL (3) | IL310604A (hr) |
LT (1) | LT3237001T (hr) |
MX (1) | MX2017008412A (hr) |
PE (1) | PE20170952A1 (hr) |
PH (1) | PH12017500966A1 (hr) |
PL (1) | PL3237001T3 (hr) |
PT (1) | PT3237001T (hr) |
RS (1) | RS65387B1 (hr) |
SG (1) | SG11201703828VA (hr) |
SI (1) | SI3237001T1 (hr) |
TN (1) | TN2017000181A1 (hr) |
TW (1) | TW201641104A (hr) |
WO (1) | WO2016103153A1 (hr) |
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 |
US20190194311A1 (en) * | 2016-07-19 | 2019-06-27 | Novartis Ag | Methods of treating new-onset plaque type psoriasis using il-17 antagonists |
TW201919582A (zh) * | 2017-07-24 | 2019-06-01 | 美商再生元醫藥公司 | 穩定化之抗體組合物及其製法 |
CN111344043A (zh) * | 2017-11-02 | 2020-06-26 | 诺华股份有限公司 | 使用白细胞介素-17(il-17)拮抗剂治疗肌腱病的方法 |
GB201719447D0 (en) * | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
CA3083971A1 (en) * | 2017-11-30 | 2019-06-06 | Bio-Thera Solutions, Ltd. | Liquid formulation of humanized antibody for treating il-6 related diseases |
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 |
AU2020225202B2 (en) | 2019-02-18 | 2023-10-26 | Eli Lilly And Company | Therapeutic antibody formulation |
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 |
KR20220066318A (ko) | 2019-09-20 | 2022-05-24 | 노파르티스 아게 | 인터류킨-17(il-17) 길항제를 사용한 자가면역 질환의 치료 방법 |
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 |
US20230009657A1 (en) | 2019-11-19 | 2023-01-12 | 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 |
WO2022258045A1 (zh) * | 2021-06-11 | 2022-12-15 | 山东先声生物制药有限公司 | 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 |
CN117883376B (zh) * | 2024-03-14 | 2024-06-25 | 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 (32)
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 |
DK1133558T4 (en) | 1998-11-27 | 2016-05-17 | Ucb Sa | Compositions and methods for increasing bone mineralization |
US20040009535A1 (en) | 1998-11-27 | 2004-01-15 | Celltech R&D, Inc. | Compositions and methods for increasing bone mineralization |
HU227347B1 (en) * | 1999-10-04 | 2011-04-28 | Novartis Vaccines & Diagnostic | 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 |
CA2476410C (en) | 2002-03-01 | 2013-09-24 | Celltech R & D, Inc. | Methods to increase or decrease bone density |
US20040023356A1 (en) | 2002-06-14 | 2004-02-05 | Robb Krumlauf | Wise/Sost nucleic acid sequences and amino acid sequences |
JP4688802B2 (ja) | 2003-06-16 | 2011-05-25 | セルテック アール アンド ディー, インコーポレイテッド | 骨の鉱化作用を増大させるためのスクレロスチンに特異的な抗体および方法 |
US8461155B2 (en) | 2003-09-22 | 2013-06-11 | University Of Connecticut | Sclerostin and the inhibition of WNT signaling and bone formation |
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 |
US8003108B2 (en) | 2005-05-03 | 2011-08-23 | Amgen Inc. | Sclerostin epitopes |
US7592429B2 (en) | 2005-05-03 | 2009-09-22 | Ucb Sa | Sclerostin-binding antibody |
RU2430110C2 (ru) | 2006-01-31 | 2011-09-27 | Новартис Аг | Антитела - антагонисты интерлейкина-17 (ил-17) для лечения рака |
US20100036091A1 (en) | 2006-11-10 | 2010-02-11 | Amgen Inc. | Antibody-based diagnostics and therapeutics |
WO2008133722A2 (en) | 2006-11-10 | 2008-11-06 | Ucb Pharma S.A. | Anti human sclerostin antibodies |
EP2114435A1 (en) | 2007-02-02 | 2009-11-11 | Novartis AG | Modulators of sclerostin binding partners for treating bone-related disorders |
EP2131860B1 (en) | 2007-03-20 | 2013-12-18 | Eli Lilly & Company | Anti-sclerostin antibodies |
CL2008002775A1 (es) | 2007-09-17 | 2008-11-07 | Amgen Inc | Uso de un agente de unión a esclerostina para inhibir la resorción ósea. |
TWI489993B (zh) | 2007-10-12 | 2015-07-01 | Novartis Ag | 骨硬化素(sclerostin)抗體組合物及使用方法 |
EA201070740A1 (ru) | 2007-12-14 | 2010-12-30 | Эмджен Инк. | Способ лечения перелома кости антителами против склеростина |
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 |
JP2012533548A (ja) * | 2009-07-14 | 2012-12-27 | バイオジェン・アイデック・エムエイ・インコーポレイテッド | 組成物における黄色形成および過酸化物形成を阻害する方法 |
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 |
CN104800844A (zh) * | 2010-11-05 | 2015-07-29 | 诺华有限公司 | 使用il-17拮抗剂治疗类风湿性关节炎的方法 |
JP2015504430A (ja) * | 2011-11-21 | 2015-02-12 | ノバルティス アーゲー | Il−7アンタゴニスト及びpsa応答又は非応答対立遺伝子を用いた乾癬性関節炎(psa)を治療する方法 |
DK2822590T3 (en) * | 2012-03-07 | 2017-01-23 | Lilly Co Eli | IL-17 antibody formulation |
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 CN CN202111362173.4A patent/CN114452380A/zh active Pending
- 2015-12-21 AU AU2015370522A patent/AU2015370522B2/en active Active
- 2015-12-21 TN TN2017000181A patent/TN2017000181A1/en unknown
- 2015-12-21 CN CN202111364411.5A patent/CN113855800A/zh active Pending
- 2015-12-21 PE PE2017001096A patent/PE20170952A1/es not_active Application Discontinuation
- 2015-12-21 EA EA201791422A patent/EA033824B1/ru not_active IP Right Cessation
- 2015-12-21 MX MX2017008412A patent/MX2017008412A/es unknown
- 2015-12-21 CN CN202111362326.5A patent/CN114452381A/zh active Pending
- 2015-12-21 US US15/538,257 patent/US11801300B2/en active Active
- 2015-12-21 PT PT158238055T patent/PT3237001T/pt unknown
- 2015-12-21 CN CN202111362275.6A patent/CN113876947A/zh active Pending
- 2015-12-21 BR BR112017013240A patent/BR112017013240A2/pt not_active Application Discontinuation
- 2015-12-21 CA CA2971800A patent/CA2971800A1/en active Pending
- 2015-12-21 SI SI201531997T patent/SI3237001T1/sl unknown
- 2015-12-21 LT LTEPPCT/IB2015/059836T patent/LT3237001T/lt unknown
- 2015-12-21 RS RS20240422A patent/RS65387B1/sr unknown
- 2015-12-21 WO PCT/IB2015/059836 patent/WO2016103153A1/en active Application Filing
- 2015-12-21 JP JP2017551391A patent/JP6770974B2/ja active Active
- 2015-12-21 SG SG11201703828VA patent/SG11201703828VA/en unknown
- 2015-12-21 TW TW104143009A patent/TW201641104A/zh unknown
- 2015-12-21 FI FIEP15823805.5T patent/FI3237001T3/fi active
- 2015-12-21 CN CN201580076632.9A patent/CN107257692B/zh active Active
- 2015-12-21 KR KR1020237007135A patent/KR102614921B1/ko active IP Right Grant
- 2015-12-21 HR HRP20240253TT patent/HRP20240253T1/hr unknown
- 2015-12-21 IL IL310604A patent/IL310604A/en unknown
- 2015-12-21 KR KR1020177016756A patent/KR102506173B1/ko active IP Right Grant
- 2015-12-21 PL PL15823805.5T patent/PL3237001T3/pl unknown
- 2015-12-21 DK DK15823805.5T patent/DK3237001T3/da active
- 2015-12-21 KR KR1020237043038A patent/KR20230173742A/ko not_active Application Discontinuation
- 2015-12-21 EP EP24155578.8A patent/EP4372005A2/en active Pending
- 2015-12-21 EP EP15823805.5A patent/EP3237001B1/en active Active
-
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
- 2021-10-17 IL IL287328A patent/IL287328B2/en unknown
-
2023
- 2023-06-09 JP JP2023095510A patent/JP2023113906A/ja active Pending
- 2023-10-04 US US18/481,213 patent/US20240173404A1/en active Pending
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
HRP20240253T1 (hr) | Farmaceutski proizvodi i stabilni tekući pripravci od il-17 protutijela | |
PH12017500844A1 (en) | Stable protein solution formulation containing high concentration of an anti-vegf antibody | |
ZA202102906B (en) | Liquid protein formulations containing viscosity-lowering agents | |
AR107014A1 (es) | Formulación farmacéutica acuosa | |
JP2018502910A5 (hr) | ||
PH12018500422B1 (en) | Rapid-acting insulin compositions | |
EP4233892A3 (en) | Stable anti-ifnar1 formulation | |
MX2017010400A (es) | Formulacion liquida estable para anticuerpos monoclonales. | |
PH12018500690A1 (en) | Novel insulin analogs and use thereof | |
WO2012121523A3 (en) | Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt | |
NZ702342A (en) | Pharmaceutical formulation | |
CL2021001587A1 (es) | Formulación de solución de proteínas que contiene una alta concentración de un anticuerpo anti-vegf | |
AR102572A1 (es) | Formulación de solución de proteína estable que contiene alta concentración de un anticuerpo anti-vegf | |
AR112343A1 (es) | Composiciones de anticuerpos estabilizadas y métodos para producirlas | |
TH170460A (th) | "องค์ประกอบเภสัชภัณฑ์สำหรับการให้ทางปากซึ่งประกอบรวมด้วยแทกเซน" | |
IN2014MU01178A (hr) | ||
TH170460B (th) | "องค์ประกอบเภสัชภัณฑ์สำหรับการให้ทางปากซึ่งประกอบรวมด้วยแทกเซน" | |
EA027609B8 (ru) | Способ получения интерферона бета-1альфа и фармацевтическая композиция, содержащая интерферон бета-1альфа |