BR112019011769A2 - composição de anticorpo anti-c5 aquosa estável - Google Patents
composição de anticorpo anti-c5 aquosa estávelInfo
- Publication number
- BR112019011769A2 BR112019011769A2 BR112019011769-5A BR112019011769A BR112019011769A2 BR 112019011769 A2 BR112019011769 A2 BR 112019011769A2 BR 112019011769 A BR112019011769 A BR 112019011769A BR 112019011769 A2 BR112019011769 A2 BR 112019011769A2
- Authority
- BR
- Brazil
- Prior art keywords
- stable aqueous
- antibody composition
- aqueous anti
- aqueous composition
- stabilizer
- Prior art date
Links
- 239000003381 stabilizer Substances 0.000 abstract 3
- 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 abstract 2
- 239000004475 Arginine Substances 0.000 abstract 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 abstract 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 2
- 229930006000 Sucrose Natural products 0.000 abstract 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 2
- 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 abstract 2
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 2
- 239000000600 sorbitol Substances 0.000 abstract 2
- 239000005720 sucrose Substances 0.000 abstract 2
- 239000004094 surface-active agent Substances 0.000 abstract 2
- 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 abstract 1
- 230000001627 detrimental effect Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 125000000647 trehalose group Chemical group 0.000 abstract 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- 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
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
trata-se de uma composição aquosa estável que compreende (a) cerca de 10 a cerca de 100 mg/ml de um anticorpo anti-c5, (b) um tensoativo, (c) um estabilizante, e (d) um tampão que tem um ph de cerca de 5,0 a cerca de 7,8, em que o estabilizante é trealose, sacarose, sorbitol, arginina, ou uma combinação dos mesmos. em uma modalidade específica, a composição aquosa estável consiste essencialmente em (a) cerca de 10 ou cerca de 50 mg/ml de um anticorpo anti-c5, (b) cerca de 0,01 a cerca de 0,1 % (p/v) de um tensoativo, (c) cerca de 1 a cerca de 20 mm de tampão que tem um ph de 5,5 a 7,5, e (d) um estabilizante selecionado a partir do grupo que consiste em trealose, sacarose, sorbitol, arginina, ou uma combinação dos mesmos. trata-se também de um método de tratamento de um transtorno em que a atividade de c5 é prejudicial em um indivíduo que compreende administrar a composição aquosa estável ao indivíduo.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662435476P | 2016-12-16 | 2016-12-16 | |
| PCT/IB2017/057348 WO2018109588A2 (en) | 2016-12-16 | 2017-11-22 | Stable aqueous anti-c5 antibody composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112019011769A2 true BR112019011769A2 (pt) | 2019-11-12 |
Family
ID=62558093
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112019011769-5A BR112019011769A2 (pt) | 2016-12-16 | 2017-11-22 | composição de anticorpo anti-c5 aquosa estável |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20190330319A1 (pt) |
| EP (1) | EP3554543A4 (pt) |
| KR (1) | KR102579940B1 (pt) |
| CN (1) | CN110087683A (pt) |
| AU (1) | AU2017376884A1 (pt) |
| BR (1) | BR112019011769A2 (pt) |
| CA (1) | CA3044502A1 (pt) |
| WO (1) | WO2018109588A2 (pt) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL309975A (en) | 2016-06-14 | 2024-03-01 | Regeneron Pharma | Antibodies against C5 and their uses |
| CN111630065A (zh) | 2017-12-13 | 2020-09-04 | 瑞泽恩制药公司 | 抗c5抗体组合及其用途 |
| KR20210059646A (ko) * | 2019-11-15 | 2021-05-25 | 삼성바이오에피스 주식회사 | 항체 의약품용 액상 조성물 |
| CN113274494B (zh) * | 2021-06-07 | 2022-09-20 | 武汉生物制品研究所有限责任公司 | 一种抗SARS-CoV-2的重组全人源单克隆抗体的液体制剂 |
| WO2022261716A1 (en) * | 2021-06-16 | 2022-12-22 | Exopharm Limited | Aqueous formulations for preservation of extracellular vesicles |
| CN116712390B (zh) * | 2023-08-04 | 2023-11-14 | 上海览屹医药科技有限公司 | 一种高浓度高稳定性的抗体制剂及其制备方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US9415102B2 (en) * | 2002-09-06 | 2016-08-16 | Alexion Pharmaceuticals, Inc. | High concentration formulations of anti-C5 antibodies |
| DK2359834T5 (en) * | 2006-03-15 | 2017-02-06 | Alexion Pharma Inc | Treatment of paroxysmal nocturnal hemoglobinuria patients with a complement inhibitor |
| CN104768578A (zh) * | 2012-10-25 | 2015-07-08 | 米迪缪尼有限公司 | 稳定的低粘度抗体配制品 |
| NZ631007A (en) * | 2014-03-07 | 2015-10-30 | Alexion Pharma Inc | Anti-c5 antibodies having improved pharmacokinetics |
| WO2016061066A1 (en) * | 2014-10-15 | 2016-04-21 | Alexion Pharmaceuticals, Inc. | Methods of replicating a large scale eculizumab production cell culture |
| LT3233921T (lt) * | 2014-12-19 | 2021-12-10 | Chugai Seiyaku Kabushiki Kaisha | Anti-c5 antikūnai ir panaudojimo būdai |
-
2017
- 2017-11-22 WO PCT/IB2017/057348 patent/WO2018109588A2/en unknown
- 2017-11-22 AU AU2017376884A patent/AU2017376884A1/en active Pending
- 2017-11-22 CN CN201780078107.XA patent/CN110087683A/zh active Pending
- 2017-11-22 KR KR1020197020716A patent/KR102579940B1/ko active IP Right Grant
- 2017-11-22 BR BR112019011769-5A patent/BR112019011769A2/pt unknown
- 2017-11-22 CA CA3044502A patent/CA3044502A1/en active Pending
- 2017-11-22 EP EP17880002.5A patent/EP3554543A4/en active Pending
- 2017-11-22 US US16/470,047 patent/US20190330319A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3554543A4 (en) | 2020-09-02 |
| US20190330319A1 (en) | 2019-10-31 |
| KR20190088081A (ko) | 2019-07-25 |
| CN110087683A (zh) | 2019-08-02 |
| WO2018109588A2 (en) | 2018-06-21 |
| WO2018109588A3 (en) | 2018-08-02 |
| CA3044502A1 (en) | 2018-06-21 |
| AU2017376884A1 (en) | 2019-05-30 |
| KR102579940B1 (ko) | 2023-09-15 |
| EP3554543A2 (en) | 2019-10-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
| B06W | Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette] |