RU2019120404A - Составы антител - Google Patents
Составы антител Download PDFInfo
- Publication number
- RU2019120404A RU2019120404A RU2019120404A RU2019120404A RU2019120404A RU 2019120404 A RU2019120404 A RU 2019120404A RU 2019120404 A RU2019120404 A RU 2019120404A RU 2019120404 A RU2019120404 A RU 2019120404A RU 2019120404 A RU2019120404 A RU 2019120404A
- Authority
- RU
- Russia
- Prior art keywords
- composition
- specified
- amount
- trehalose
- composition according
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 74
- 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 26
- 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 26
- 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 26
- 238000000034 method Methods 0.000 claims 26
- 239000004094 surface-active agent Substances 0.000 claims 10
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 9
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 229960003347 obinutuzumab Drugs 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 229920001983 poloxamer Polymers 0.000 claims 4
- 229960000502 poloxamer Drugs 0.000 claims 4
- 229920000136 polysorbate Polymers 0.000 claims 4
- 229950008882 polysorbate Drugs 0.000 claims 4
- 229920001993 poloxamer 188 Polymers 0.000 claims 3
- 229940044519 poloxamer 188 Drugs 0.000 claims 3
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- 238000004220 aggregation Methods 0.000 claims 2
- 230000002776 aggregation Effects 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- 229940126622 therapeutic monoclonal antibody Drugs 0.000 claims 2
- 208000028018 Lymphocytic leukaemia Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 230000004071 biological effect Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 208000003747 lymphoid leukemia Diseases 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical group [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
Classifications
-
- 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
-
- 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
- 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
- A61K47/02—Inorganic compounds
-
- 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
- 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
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- 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
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/54—F(ab')2
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
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)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Endocrinology (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361780899P | 2013-03-13 | 2013-03-13 | |
| US61/780,899 | 2013-03-13 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015143607A Division RU2694055C2 (ru) | 2013-03-13 | 2014-03-13 | Составы антител |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2019120404A true RU2019120404A (ru) | 2019-08-06 |
Family
ID=51625441
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019120404A RU2019120404A (ru) | 2013-03-13 | 2014-03-13 | Составы антител |
| RU2015143607A RU2694055C2 (ru) | 2013-03-13 | 2014-03-13 | Составы антител |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015143607A RU2694055C2 (ru) | 2013-03-13 | 2014-03-13 | Составы антител |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US10010611B2 (OSRAM) |
| EP (2) | EP3744345B1 (OSRAM) |
| JP (2) | JP6511609B2 (OSRAM) |
| KR (2) | KR102048512B1 (OSRAM) |
| CN (2) | CN110538322A (OSRAM) |
| AR (1) | AR095396A1 (OSRAM) |
| AU (2) | AU2014243783B2 (OSRAM) |
| BR (1) | BR112015022210A8 (OSRAM) |
| CA (1) | CA2906057A1 (OSRAM) |
| IL (2) | IL240886B (OSRAM) |
| MX (2) | MX365567B (OSRAM) |
| MY (2) | MY185551A (OSRAM) |
| NZ (2) | NZ711567A (OSRAM) |
| RU (2) | RU2019120404A (OSRAM) |
| SG (2) | SG11201507475UA (OSRAM) |
| WO (1) | WO2014160490A1 (OSRAM) |
| ZA (2) | ZA201506981B (OSRAM) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX365567B (es) | 2013-03-13 | 2019-06-07 | Genentech Inc | Formulaciones de anticuerpo. |
| EP3193932B1 (en) | 2014-09-15 | 2023-04-26 | F. Hoffmann-La Roche AG | Antibody formulations |
| TWI806150B (zh) | 2014-11-07 | 2023-06-21 | 瑞士商諾華公司 | 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物 |
| US10894083B2 (en) * | 2015-01-28 | 2021-01-19 | Pfizer Inc. | Stable aqueous anti-vascular endothelial growth factor (VEGF) antibody formulation |
| US11149091B2 (en) * | 2015-12-09 | 2021-10-19 | Cedars-Sinai Medical Center | Methods for treating nephrotic syndrome |
| CN105920600A (zh) * | 2016-04-19 | 2016-09-07 | 上海景泽生物技术有限公司 | 一种稳定的抗vegf抗体制剂及其用途 |
| SG10201912369QA (en) | 2016-06-27 | 2020-02-27 | Morphosys Ag | Anti-cd19 antibody formulations |
| CN107384932B (zh) * | 2016-08-31 | 2020-10-20 | 北京天广实生物技术股份有限公司 | 抗人cd20人源化单克隆抗体mil62、其制备方法及用途 |
| EP3541413A2 (en) | 2016-11-21 | 2019-09-25 | Polpharma Biologics S.A. | Aqueous pharmaceutical formulations |
| CN108686204A (zh) * | 2017-04-07 | 2018-10-23 | 浙江海正药业股份有限公司 | 包含组氨酸缓冲体系的英夫利西单抗组合物 |
| US11865175B1 (en) | 2017-04-28 | 2024-01-09 | Cedars-Sinai Medical Center | Post-transplantation prophylaxis and treatments for antibody-mediated rejection of solid organ transplant |
| CN107881160A (zh) * | 2017-08-11 | 2018-04-06 | 百奥泰生物科技(广州)有限公司 | 一种由基因组被编辑的cho宿主细胞产生的具有独特糖谱的重组抗体及其制备方法 |
| CN107899020A (zh) * | 2017-08-11 | 2018-04-13 | 百奥泰生物科技(广州)有限公司 | Cd20阳性疾病治疗的化合物及方法 |
| US20190099489A1 (en) * | 2017-09-29 | 2019-04-04 | Janssen Biotech, Inc. | Novel Formulations Which Stabilize Low Dose Antibody Compositions |
| CA3189025A1 (en) * | 2017-12-22 | 2019-06-27 | Samsung Bioepis Co., Ltd. | Liquid composition comprising vegf antagonist |
| SG11202100699WA (en) | 2018-08-16 | 2021-02-25 | Emd Millipore Corp | Closed bioprocessing device |
| JP7266108B2 (ja) | 2019-02-18 | 2023-04-27 | イーライ リリー アンド カンパニー | 治療用抗体製剤 |
| EP4025250A4 (en) * | 2019-10-12 | 2024-01-17 | Bio-Thera Solutions, Ltd. | FORMULATION OF ANTI-CD20 ANTIBODIES AND USE OF ANTI-CD20 ANTIBODIES FOR THE TREATMENT OF CD20-POSITIVE DISEASES |
| AU2021232369B2 (en) * | 2020-03-04 | 2025-06-05 | Shanghai Henlius Biotech, Inc. | Pharmaceutical formulation comprising bevacizumab |
| WO2022265591A1 (en) * | 2021-06-18 | 2022-12-22 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Pharmaceutical compositions of bevacizumab |
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