AU2020334880A1 - High concentration anti-C5 formulations - Google Patents
High concentration anti-C5 formulations Download PDFInfo
- Publication number
- AU2020334880A1 AU2020334880A1 AU2020334880A AU2020334880A AU2020334880A1 AU 2020334880 A1 AU2020334880 A1 AU 2020334880A1 AU 2020334880 A AU2020334880 A AU 2020334880A AU 2020334880 A AU2020334880 A AU 2020334880A AU 2020334880 A1 AU2020334880 A1 AU 2020334880A1
- Authority
- AU
- Australia
- Prior art keywords
- water
- arginine
- histidine
- h4h12166p
- sucrose
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/0012—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
-
- 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
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Endocrinology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962888086P | 2019-08-16 | 2019-08-16 | |
| US62/888,086 | 2019-08-16 | ||
| PCT/US2020/046314 WO2021034639A1 (en) | 2019-08-16 | 2020-08-14 | High concentration anti-c5 formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2020334880A1 true AU2020334880A1 (en) | 2022-03-24 |
Family
ID=72560889
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2020334880A Pending AU2020334880A1 (en) | 2019-08-16 | 2020-08-14 | High concentration anti-C5 formulations |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20210046182A1 (https=) |
| EP (1) | EP4013784A1 (https=) |
| JP (2) | JP7813222B2 (https=) |
| KR (1) | KR20220047826A (https=) |
| CN (1) | CN116782876A (https=) |
| AU (1) | AU2020334880A1 (https=) |
| BR (1) | BR112022002831A2 (https=) |
| CA (1) | CA3145621A1 (https=) |
| CL (1) | CL2022000340A1 (https=) |
| CO (1) | CO2022001097A2 (https=) |
| IL (1) | IL290034A (https=) |
| JO (1) | JOP20220030A1 (https=) |
| MX (1) | MX2022001896A (https=) |
| PH (1) | PH12022550167A1 (https=) |
| WO (1) | WO2021034639A1 (https=) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL288931B2 (en) | 2013-03-14 | 2025-05-01 | Alnylam Pharmaceuticals Inc | Compositions comprising a complementary portion of C5 IRNA and methods of using them |
| CN107635527B (zh) | 2015-03-10 | 2021-04-23 | 里珍纳龙药品有限公司 | 无菌刺穿系统和方法 |
| CN116769024A (zh) | 2016-06-14 | 2023-09-19 | 瑞泽恩制药公司 | 抗c5抗体及其用途 |
| IL308643B2 (en) | 2017-05-05 | 2025-02-01 | Regeneron Pharma | Auto-injector |
| CA3274059A1 (en) | 2017-12-13 | 2026-03-02 | Regeneron Pharmaceuticals, Inc. | Anti-c5 antibody combinations and uses thereof |
| US20240415980A1 (en) | 2021-10-28 | 2024-12-19 | Regeneron Pharmaceuticals, Inc. | Crispr/cas-related methods and compositions for knocking out c5 |
| USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
| KR20250044336A (ko) * | 2022-07-27 | 2025-03-31 | 세파론 엘엘씨 | 궤양성 결장염 및 크론병의 치료를 위한 항-tl1a 항체 |
| IL318297A (en) * | 2022-07-27 | 2025-03-01 | Cephalon Llc | Anti-TL1A antibody formulations |
| JP2025536552A (ja) * | 2022-10-28 | 2025-11-07 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 抗Ｃ５抗体／Ｃ５ ｉＲＮＡ合剤および併用療法 |
| CN121548440A (zh) | 2023-06-16 | 2026-02-17 | 里珍纳龙药品有限公司 | 医疗装置包装及相关方法 |
| 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 |
| WO2025075970A1 (en) | 2023-10-02 | 2025-04-10 | Regeneron Pharmaceuticals, Inc. | Drug delivery device safety system |
| CN118460651B (zh) * | 2024-07-10 | 2025-03-18 | 凯莱英医药集团（天津）股份有限公司 | 制备Cemdisiran的方法 |
| CN119454939A (zh) * | 2024-11-28 | 2025-02-18 | 北海康成(苏州)生物制药有限公司 | 一种欧莫扑拜单抗原液及其制备方法 |
Family Cites Families (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US5981501A (en) | 1995-06-07 | 1999-11-09 | Inex Pharmaceuticals Corp. | Methods for encapsulating plasmids in lipid bilayers |
| AU733310C (en) | 1997-05-14 | 2001-11-29 | University Of British Columbia, The | High efficiency encapsulation of charged therapeutic agents in lipid vesicles |
| US8101348B2 (en) | 2002-07-10 | 2012-01-24 | Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften E.V. | RNA-interference by single-stranded RNA molecules |
| ITMI20021527A1 (it) | 2002-07-11 | 2004-01-12 | Consiglio Nazionale Ricerche | Anticorpi anti componente c5 del complemento e loro uso |
| CA2638811A1 (en) * | 2006-02-03 | 2007-08-16 | Medimmune, Llc | Protein formulations |
| CA2674608A1 (en) * | 2007-01-09 | 2008-07-17 | Wyeth | Anti-il-13 antibody formulations and uses thereof |
| CA2721333C (en) | 2008-04-15 | 2020-12-01 | Protiva Biotherapeutics, Inc. | Novel lipid formulations for nucleic acid delivery |
| PY09026846A (es) | 2008-08-05 | 2015-09-01 | Novartis Ag | Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5 |
| AU2010221156A1 (en) * | 2009-03-06 | 2011-09-22 | Genentech, Inc. | Antibody formulation |
| KR101766408B1 (ko) | 2009-06-10 | 2017-08-10 | 알닐람 파마슈티칼스 인코포레이티드 | 향상된 지질 조성물 |
| IL288931B2 (en) | 2013-03-14 | 2025-05-01 | Alnylam Pharmaceuticals Inc | Compositions comprising a complementary portion of C5 IRNA and methods of using them |
| US10238700B2 (en) * | 2014-01-02 | 2019-03-26 | Genelux Corporation | Oncolytic virus adjunct therapy with agents that increase virus infectivity |
| CA2940319A1 (en) | 2014-03-20 | 2015-09-24 | Inflarx Gmbh | Inhibitors of c5a for the treatment of viral pneumonia |
| WO2017055966A1 (en) * | 2015-10-01 | 2017-04-06 | Pfizer Inc. | Low viscosity antibody compositions |
| EP3464351A1 (en) | 2016-06-07 | 2019-04-10 | Novartis AG | Anti-c5 antibody for treating patients with complement c5 polymorphism |
| CN116769024A (zh) * | 2016-06-14 | 2023-09-19 | 瑞泽恩制药公司 | 抗c5抗体及其用途 |
| EP3522918A1 (en) * | 2016-10-06 | 2019-08-14 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| DK3658184T5 (da) * | 2017-07-27 | 2024-08-26 | Alexion Pharma Inc | Højkoncentrerede anti-c5-antistofformuleringer |
| CN118512588A (zh) * | 2017-10-26 | 2024-08-20 | 亚力兄制药公司 | 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用 |
| CA3274059A1 (en) * | 2017-12-13 | 2026-03-02 | Regeneron Pharmaceuticals, Inc. | Anti-c5 antibody combinations and uses thereof |
-
2020
- 2020-08-14 WO PCT/US2020/046314 patent/WO2021034639A1/en not_active Ceased
- 2020-08-14 US US16/993,434 patent/US20210046182A1/en active Pending
- 2020-08-14 AU AU2020334880A patent/AU2020334880A1/en active Pending
- 2020-08-14 BR BR112022002831A patent/BR112022002831A2/pt unknown
- 2020-08-14 CA CA3145621A patent/CA3145621A1/en active Pending
- 2020-08-14 JP JP2022509593A patent/JP7813222B2/ja active Active
- 2020-08-14 KR KR1020227008645A patent/KR20220047826A/ko active Pending
- 2020-08-14 PH PH1/2022/550167A patent/PH12022550167A1/en unknown
- 2020-08-14 JO JOP/2022/0030A patent/JOP20220030A1/ar unknown
- 2020-08-14 MX MX2022001896A patent/MX2022001896A/es unknown
- 2020-08-14 CN CN202080069383.1A patent/CN116782876A/zh active Pending
- 2020-08-14 EP EP20775090.2A patent/EP4013784A1/en active Pending
-
2022
- 2022-01-23 IL IL290034A patent/IL290034A/en unknown
- 2022-02-02 CO CONC2022/0001097A patent/CO2022001097A2/es unknown
- 2022-02-09 CL CL2022000340A patent/CL2022000340A1/es unknown
-
2025
- 2025-09-12 JP JP2025151837A patent/JP2026003133A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA3145621A1 (en) | 2021-02-25 |
| JP2022544589A (ja) | 2022-10-19 |
| US20210046182A1 (en) | 2021-02-18 |
| MX2022001896A (es) | 2022-06-02 |
| BR112022002831A2 (pt) | 2022-06-28 |
| PH12022550167A1 (en) | 2023-05-08 |
| CO2022001097A2 (es) | 2022-03-08 |
| KR20220047826A (ko) | 2022-04-19 |
| CN116782876A (zh) | 2023-09-19 |
| JP2026003133A (ja) | 2026-01-09 |
| JOP20220030A1 (ar) | 2023-01-30 |
| IL290034A (en) | 2022-03-01 |
| CL2022000340A1 (es) | 2022-10-07 |
| WO2021034639A1 (en) | 2021-02-25 |
| JP7813222B2 (ja) | 2026-02-12 |
| WO2021034639A4 (en) | 2021-04-15 |
| EP4013784A1 (en) | 2022-06-22 |
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