CO2020001960A2 - Formulaciones de anticuerpos anti-c5 de alta concentración - Google Patents
Formulaciones de anticuerpos anti-c5 de alta concentraciónInfo
- Publication number
- CO2020001960A2 CO2020001960A2 CONC2020/0001960A CO2020001960A CO2020001960A2 CO 2020001960 A2 CO2020001960 A2 CO 2020001960A2 CO 2020001960 A CO2020001960 A CO 2020001960A CO 2020001960 A2 CO2020001960 A2 CO 2020001960A2
- Authority
- CO
- Colombia
- Prior art keywords
- solutions
- high concentration
- antibody formulations
- concentration anti
- antibody
- Prior art date
Links
Classifications
-
- 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
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- 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
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- 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
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Inorganic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762537741P | 2017-07-27 | 2017-07-27 | |
| PCT/US2018/044071 WO2019023564A1 (en) | 2017-07-27 | 2018-07-27 | ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO2020001960A2 true CO2020001960A2 (es) | 2020-04-13 |
Family
ID=63209670
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CONC2020/0001960A CO2020001960A2 (es) | 2017-07-27 | 2020-02-24 | Formulaciones de anticuerpos anti-c5 de alta concentración |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US11365241B2 (https=) |
| EP (2) | EP3658184B1 (https=) |
| JP (4) | JP7079844B2 (https=) |
| KR (2) | KR102576012B1 (https=) |
| CN (2) | CN116271012A (https=) |
| AU (3) | AU2018306612C1 (https=) |
| BR (1) | BR112020001703B1 (https=) |
| CA (1) | CA3069756C (https=) |
| CO (1) | CO2020001960A2 (https=) |
| DK (1) | DK3658184T5 (https=) |
| ES (1) | ES2965486T3 (https=) |
| FI (1) | FI3658184T3 (https=) |
| HU (1) | HUE064436T2 (https=) |
| LT (1) | LT3658184T (https=) |
| MX (2) | MX392444B (https=) |
| PL (1) | PL3658184T3 (https=) |
| PT (1) | PT3658184T (https=) |
| SI (1) | SI3658184T1 (https=) |
| WO (1) | WO2019023564A1 (https=) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019517473A (ja) | 2016-05-27 | 2019-06-24 | アレクシオン ファーマシューティカルズ インコーポレイテッドAlexion Pharmaceuticals, Inc. | 難治性全身型重症筋無力症の処置のための方法 |
| SI3658184T1 (sl) | 2017-07-27 | 2024-01-31 | Alexion Pharmaceuticals, Inc., | Formulacije z visoko koncentracijo protiteles proti-C5 |
| CA3080187A1 (en) | 2017-10-26 | 2019-05-02 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) |
| JP7577542B2 (ja) | 2018-06-04 | 2024-11-05 | アレクシオン ファーマシューティカルズ, インコーポレイテッド | 小児患者における非典型溶血性尿毒症症候群(aHUS)の治療のための抗C5抗体の用量および投与 |
| WO2020006266A1 (en) | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| CN112996561A (zh) * | 2018-10-30 | 2021-06-18 | 亚力兄制药公司 | 用于治疗阵发性睡眠性血红蛋白尿症(pnh)的抗c5抗体的皮下剂量和施用 |
| CA3127797A1 (en) * | 2019-01-25 | 2020-07-30 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) |
| MX2021009789A (es) * | 2019-02-14 | 2021-11-17 | Alexion Pharma Inc | Dosificacion y administracion de anticuerpos anti-c5 para el tratamiento de miastenia gravis generalizada. |
| JP7813222B2 (ja) * | 2019-08-16 | 2026-02-12 | 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 | 高濃度抗c5製剤 |
| AU2020337093B2 (en) * | 2019-08-30 | 2025-02-27 | Kashiv Biosciences, Llc | Novel formulation of highly concentrated pharmacologically active antibody |
| WO2021067526A1 (en) * | 2019-10-02 | 2021-04-08 | Alexion Pharmaceuticals, Inc. | Complement inhibitors for treating drug-induced complement-mediated response |
| EP4054634A1 (en) * | 2019-11-08 | 2022-09-14 | Alexion Pharmaceuticals, Inc. | High concentration anti-c5 antibody formulations |
| JP2023520249A (ja) * | 2020-05-15 | 2023-05-16 | エフ. ホフマン-ラ ロシュ アーゲー | 非経口タンパク質溶液中の可視粒子形成の防止方法 |
| CN116261569A (zh) * | 2020-09-21 | 2023-06-13 | 阿雷克森制药公司 | 用于治疗包括狼疮性肾炎(LN)和/或IgA肾病(IgAN)的C5介导的肾小球肾炎(GN)的抗C5抗体的剂量和施用 |
| KR20230134533A (ko) * | 2021-01-22 | 2023-09-21 | 알렉시온 파마슈티칼스, 인코포레이티드 | 항-c5 항체를 이용한 보체 매개 혈전성 미세혈관병증의치료 방법 |
| TW202404632A (zh) * | 2022-04-04 | 2024-02-01 | 瑞士商赫孚孟拉羅股份公司 | 用於藉由使用抗c5抗體克羅伐單抗治療或預防格林-巴利症候群之劑量及投予方案 |
| TW202423479A (zh) * | 2022-09-28 | 2024-06-16 | 美商阿雷希昂製藥公司 | 用於預防或最小化患有慢性腎病的患者中的心臟手術相關急性腎損傷(csa-aki)和/或隨後的主要不良腎事件(make)的抗c5抗體之劑量及投與 |
| 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 |
| CN118604345A (zh) * | 2024-05-31 | 2024-09-06 | 上海览屹医药科技有限公司 | 酶联免疫方法测定单克隆抗体浓度 |
| CN121186347B (zh) * | 2025-11-24 | 2026-02-24 | 国家心血管病中心 | 一种利用动脉血对目标物质进行免疫检测的方法和试剂盒 |
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