PL2616090T3 - Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego - Google Patents
Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnegoInfo
- Publication number
- PL2616090T3 PL2616090T3 PL11764040.9T PL11764040T PL2616090T3 PL 2616090 T3 PL2616090 T3 PL 2616090T3 PL 11764040 T PL11764040 T PL 11764040T PL 2616090 T3 PL2616090 T3 PL 2616090T3
- Authority
- PL
- Poland
- Prior art keywords
- immunoglobulins
- histidine
- stabilization
- neutral
- aqueous formulation
- Prior art date
Links
- 108060003951 Immunoglobulin Proteins 0.000 title 1
- 230000002378 acidificating effect Effects 0.000 title 1
- 239000013011 aqueous formulation Substances 0.000 title 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 title 1
- 102000018358 immunoglobulin Human genes 0.000 title 1
- 229940072221 immunoglobulins Drugs 0.000 title 1
- 230000007935 neutral effect Effects 0.000 title 1
- 230000006641 stabilisation Effects 0.000 title 1
- 238000011105 stabilization Methods 0.000 title 1
Classifications
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- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K47/16—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
- A61K9/0012—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US38420910P | 2010-09-17 | 2010-09-17 | |
| PCT/US2011/052053 WO2012037534A1 (en) | 2010-09-17 | 2011-09-16 | Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL2616090T3 true PL2616090T3 (pl) | 2023-12-18 |
Family
ID=44721088
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL11764040.9T PL2616090T3 (pl) | 2010-09-17 | 2011-09-16 | Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego |
Country Status (23)
| Country | Link |
|---|---|
| US (4) | US8795658B2 (pl) |
| EP (3) | EP4289445A3 (pl) |
| JP (4) | JP2013544762A (pl) |
| KR (1) | KR101879885B1 (pl) |
| CN (2) | CN103282042B (pl) |
| AR (3) | AR083034A1 (pl) |
| AU (2) | AU2011301803A1 (pl) |
| BR (1) | BR112013006308B1 (pl) |
| CA (2) | CA2810734A1 (pl) |
| CL (1) | CL2013000724A1 (pl) |
| CO (1) | CO6660498A2 (pl) |
| DK (1) | DK2616090T3 (pl) |
| EA (2) | EA027353B1 (pl) |
| ES (1) | ES2959479T3 (pl) |
| FI (1) | FI2616090T3 (pl) |
| IL (1) | IL225093B (pl) |
| MX (1) | MX351706B (pl) |
| MY (1) | MY188828A (pl) |
| PL (1) | PL2616090T3 (pl) |
| PT (1) | PT2616090T (pl) |
| SG (1) | SG188487A1 (pl) |
| TW (2) | TW201213342A (pl) |
| WO (2) | WO2012037530A1 (pl) |
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| US20140186361A1 (en) | 2012-09-07 | 2014-07-03 | Coherus Biosciences, Inc. | Stable Aqueous Formulations of Adalimumab |
| TWI489994B (zh) | 2008-03-17 | 2015-07-01 | Baxter Healthcare Sa | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
| PT2477603E (pt) * | 2009-09-17 | 2016-06-16 | Baxalta Inc | Co-formulação estável de hialuronidase e imunoglobulina e métodos para a sua utilização |
| PL2616090T3 (pl) * | 2010-09-17 | 2023-12-18 | Takeda Pharmaceutical Company Limited | Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego |
| HUE044737T2 (hu) * | 2013-05-06 | 2019-11-28 | Baxalta Inc | Alzheimer-kór szubpopulációk kezelése egyesített immunglubulin G-vel |
| JP6516829B2 (ja) | 2014-08-04 | 2019-05-22 | シーエスエル、リミテッド | 第viii因子製剤 |
| PY1577621A (es) * | 2014-12-19 | 2017-10-02 | Prometic Biotherapeutics Inc | Composicion farmaceutica que comprende plasminogeno y uso para el mismo |
| CN104826117B (zh) * | 2015-05-05 | 2017-11-14 | 广东卫伦生物制药有限公司 | 用于人体血清免疫球蛋白溶液制剂的储存稳定剂 |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| JP2019505520A (ja) * | 2016-01-13 | 2019-02-28 | ゲンマブ エー/エス | 抗体およびその薬物コンジュゲートの製剤 |
| US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
| JPWO2018079570A1 (ja) * | 2016-10-26 | 2019-09-19 | アステラス製薬株式会社 | 安定な医薬組成物 |
| WO2018181876A1 (ja) * | 2017-03-31 | 2018-10-04 | Meiji Seikaファルマ株式会社 | 水性製剤及び注射器入り水性製剤、並びに、抗体タンパク脱凝集剤及び抗体タンパク脱凝集方法 |
| EP3774894A1 (en) | 2018-04-12 | 2021-02-17 | Amgen Inc. | Methods for making stable protein compositions |
| WO2021001522A1 (en) | 2019-07-04 | 2021-01-07 | CSL Behring Lengnau AG | A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii |
| US20240052020A1 (en) * | 2020-09-27 | 2024-02-15 | Emergent Biosolutions Canada Inc. | Hyperimmune globulin formulations |
| EP4240757A2 (en) | 2020-11-09 | 2023-09-13 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
| WO2026060350A1 (en) * | 2024-09-13 | 2026-03-19 | Regeneron Pharmaceuticals, Inc. | Methods of improving photo stability and controlling formation of hmw species in biologic formulations, and biologic formulations produced by the methods |
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| JO3417B1 (ar) | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| KR20130031247A (ko) | 2010-03-17 | 2013-03-28 | 애보트 리서치 비.브이. | 항―신경 성장 인자(ngf) 항체 조성물 |
| PL2616090T3 (pl) | 2010-09-17 | 2023-12-18 | Takeda Pharmaceutical Company Limited | Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego |
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2011
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2013
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2021
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