PL3892292T3 - Stabilizowane ciekłe preparaty zawierające przeciwciało - Google Patents
Stabilizowane ciekłe preparaty zawierające przeciwciałoInfo
- Publication number
- PL3892292T3 PL3892292T3 PL21159453.6T PL21159453T PL3892292T3 PL 3892292 T3 PL3892292 T3 PL 3892292T3 PL 21159453 T PL21159453 T PL 21159453T PL 3892292 T3 PL3892292 T3 PL 3892292T3
- Authority
- PL
- Poland
- Prior art keywords
- containing liquid
- liquid formulations
- stabilized antibody
- antibody
- stabilized
- Prior art date
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
-
- 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
- A61K47/06—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
-
- 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
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
- C07K16/248—IL-6
-
- 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
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)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2010010060 | 2010-01-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL3892292T3 true PL3892292T3 (pl) | 2024-10-07 |
Family
ID=44306888
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL11734694T PL2526963T3 (pl) | 2010-01-20 | 2011-01-20 | Stabilizowane ciekłe preparaty zawierające przeciwciało |
| PL21159453.6T PL3892292T3 (pl) | 2010-01-20 | 2011-01-20 | Stabilizowane ciekłe preparaty zawierające przeciwciało |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL11734694T PL2526963T3 (pl) | 2010-01-20 | 2011-01-20 | Stabilizowane ciekłe preparaty zawierające przeciwciało |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US10022319B2 (pl) |
| EP (4) | EP3892292B1 (pl) |
| JP (2) | JP5939799B2 (pl) |
| KR (5) | KR101944211B1 (pl) |
| CN (2) | CN105944099B (pl) |
| AR (2) | AR080428A1 (pl) |
| AU (5) | AU2011208075B2 (pl) |
| BR (1) | BR112012018023A2 (pl) |
| CA (2) | CA2786981C (pl) |
| DK (1) | DK2526963T3 (pl) |
| ES (2) | ES2671224T3 (pl) |
| IL (3) | IL296486A (pl) |
| MX (1) | MX349560B (pl) |
| MY (1) | MY185867A (pl) |
| NZ (1) | NZ601374A (pl) |
| PL (2) | PL2526963T3 (pl) |
| RU (1) | RU2653447C2 (pl) |
| SG (2) | SG182517A1 (pl) |
| TR (1) | TR201807401T4 (pl) |
| TW (2) | TWI505838B (pl) |
| WO (1) | WO2011090088A1 (pl) |
| ZA (1) | ZA201205446B (pl) |
Families Citing this family (88)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2401040A (en) | 2003-04-28 | 2004-11-03 | Chugai Pharmaceutical Co Ltd | Method for treating interleukin-6 related diseases |
| EP3623473A1 (en) | 2005-03-31 | 2020-03-18 | Chugai Seiyaku Kabushiki Kaisha | Process for production of polypeptide by regulation of assembly |
| CN101479381B (zh) | 2006-03-31 | 2015-04-29 | 中外制药株式会社 | 调控抗体血液动力学的方法 |
| ES2654040T3 (es) | 2006-03-31 | 2018-02-12 | Chugai Seiyaku Kabushiki Kaisha | Método de modificación de anticuerpos para la purificación de anticuerpos biespecíficos |
| EP3127921A1 (en) | 2007-09-26 | 2017-02-08 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substition in cdr |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| PL3202785T3 (pl) | 2009-10-26 | 2024-08-12 | F. Hoffmann-La Roche Ag | Sposób wytwarzania glikozylowanej immunoglobuliny |
| AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| KR20130086628A (ko) | 2010-11-08 | 2013-08-02 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| KR102099580B1 (ko) | 2010-11-17 | 2020-04-10 | 추가이 세이야쿠 가부시키가이샤 | 혈액응고 제viii 인자의 기능을 대체하는 기능을 갖는 다중특이성 항원 결합 분자 |
| US9574005B2 (en) | 2011-07-19 | 2017-02-21 | Chugai Seiyaku Kabushiki Kaisha | Stable Protein-containing preparation containing argininamide or analogous compound thereof |
| EP3235557B1 (en) | 2011-09-01 | 2025-04-30 | Chugai Seiyaku Kabushiki Kaisha | PROCESS FOR PREPARING A COMPOSITION COMPRISING HIGHLY CONCENTRATED ANTIBODIES BY ULTRAFILTRATION |
| EP3782653B1 (en) | 2012-04-04 | 2025-03-19 | Polaris Group | Composition comprising pegylated arginine deiminase |
| US9969794B2 (en) | 2012-05-10 | 2018-05-15 | Visterra, Inc. | HA binding agents |
| US20150157619A1 (en) * | 2012-07-10 | 2015-06-11 | Takeda Pharmaceutical Company Limited | Pharmaceutical preparation for injection |
| JP6411891B2 (ja) | 2012-10-03 | 2018-10-24 | 協和発酵キリン株式会社 | 培養液にアミノ酸を添加することによるポリペプチドの還元防止方法 |
| EP2727602A1 (en) * | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| HUE056580T2 (hu) | 2013-05-30 | 2022-02-28 | Kiniksa Pharmaceuticals Ltd | Onkosztatin-M-receptor antigénjét kötõ fehérjék |
| CA2925256C (en) | 2013-09-27 | 2023-08-15 | Chugai Seiyaku Kabushiki Kaisha | Method for producing polypeptide heteromultimer |
| AU2014354384B2 (en) | 2013-11-29 | 2018-11-08 | Ares Trading S.A. | A liquid formulation of a fusion protein comprising TNFR and Fc region |
| US10323095B2 (en) * | 2014-03-17 | 2019-06-18 | Mitsubishi Tanabe Pharma Corporation | Antibody-fynomer conjugates |
| TW201625299A (zh) | 2014-06-20 | 2016-07-16 | Chugai Pharmaceutical Co Ltd | 用於因第ｖｉｉｉ凝血因子及／或活化的第ｖｉｉｉ凝血因子的活性降低或欠缺而發病及／或進展的疾病之預防及／或治療之醫藥組成物 |
| TWI701435B (zh) | 2014-09-26 | 2020-08-11 | 日商中外製藥股份有限公司 | 測定ｆｖｉｉｉ的反應性之方法 |
| TWI700300B (zh) | 2014-09-26 | 2020-08-01 | 日商中外製藥股份有限公司 | 中和具有第ｖｉｉｉ凝血因子（ｆｖｉｉｉ）機能替代活性的物質之抗體 |
| CN107073113A (zh) * | 2014-10-18 | 2017-08-18 | 辉瑞大药厂 | 抗il‑7r抗体组合物 |
| US20180133375A1 (en) * | 2014-10-30 | 2018-05-17 | Chugai Seiyaku Kabushiki Kaisha | Pre-Filled Syringe Formulation With Needle, Which Is Equipped With Syringe Cap |
| EP3224359B1 (en) * | 2014-11-25 | 2023-10-25 | Bio-Rad Laboratories, Inc. | Arginine improves polymerase storage stability |
| SG11201705093UA (en) | 2015-02-27 | 2017-07-28 | Chugai Pharmaceutical Co Ltd | Composition for treating il-6-related diseases |
| US11142587B2 (en) | 2015-04-01 | 2021-10-12 | Chugai Seiyaku Kabushiki Kaisha | Method for producing polypeptide hetero-oligomer |
| JP6954842B2 (ja) | 2015-12-25 | 2021-10-27 | 中外製薬株式会社 | 増強された活性を有する抗体及びその改変方法 |
| KR102784832B1 (ko) | 2015-12-28 | 2025-03-21 | 추가이 세이야쿠 가부시키가이샤 | Fc 영역 함유 폴리펩타이드의 정제를 효율화하기 위한 방법 |
| CN108778261A (zh) * | 2016-01-12 | 2018-11-09 | 雷迪博士实验室有限公司 | 稳定的药物组合物 |
| WO2017121867A1 (en) * | 2016-01-13 | 2017-07-20 | Genmab A/S | Formulation for antibody and drug conjugate thereof |
| JP7104629B2 (ja) * | 2016-02-24 | 2022-07-21 | ビステラ， インコーポレイテッド | インフルエンザウイルスに対する抗体分子の製剤 |
| JP2019511531A (ja) * | 2016-04-13 | 2019-04-25 | メディミューン，エルエルシー | 高濃度のタンパク質ベース治療薬を含有する医薬組成物における安定化化合物としてのアミノ酸の使用 |
| WO2017188356A1 (ja) * | 2016-04-28 | 2017-11-02 | 中外製薬株式会社 | 抗体含有製剤 |
| TW202440153A (zh) | 2016-07-05 | 2024-10-16 | 開曼群島商北極星藥業集團股份有限公司 | 用精胺酸耗盡劑進行之組合癌症免疫療法 |
| KR102591955B1 (ko) | 2016-07-29 | 2023-10-19 | 추가이 세이야쿠 가부시키가이샤 | 증강된 fviii 보인자 기능 대체 활성을 갖는 이중특이성 항체 |
| UA129116C2 (uk) | 2016-09-06 | 2025-01-22 | Чугаі Сейяку Кабусікі Кайся | Спосіб лікування хвороби та/або зменшення частоти епізодів кровотечі, пов'язаних з хворобою, яка розвивається та/або прогресує внаслідок зниження або дефіциту активності фактора згортання крові viii та/або активованого фактора згортання крові viii |
| EP3534963B1 (en) | 2016-11-02 | 2024-04-17 | Polaris Group | Formulations of pegylated arginine deiminase |
| JP2020509025A (ja) * | 2017-03-01 | 2020-03-26 | メドイミューン・リミテッドＭｅｄＩｍｍｕｎｅ Ｌｉｍｉｔｅｄ | モノクローナル抗体製剤 |
| JPWO2018179138A1 (ja) * | 2017-03-29 | 2020-02-06 | 持田製薬株式会社 | 抗体含有液体製剤 |
| US20200093927A1 (en) | 2017-03-31 | 2020-03-26 | Meiji Seika Pharma Co., Ltd. | Aqueous formulation and in-syringe aqueous formulation, and antibody protein deaggregation agent and antibody protein deaggregation method |
| KR102687774B1 (ko) | 2017-03-31 | 2024-07-24 | 고리츠다이가쿠호징 나라켕리츠 이카다이가쿠 | 혈액 응고 제viii 인자의 기능을 대체하는 다중 특이성 항원 결합 분자를 함유하는, 혈액 응고 제ix 인자 이상증의 예방 및/또는 치료에 이용되는 의약 조성물 |
| US10493149B2 (en) | 2017-04-11 | 2019-12-03 | Kiniksa Pharmaceuticals, Ltd. | Stable anti-OSMR antibody formulation |
| WO2018200533A1 (en) * | 2017-04-28 | 2018-11-01 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| CN110913906A (zh) | 2017-05-02 | 2020-03-24 | 默沙东公司 | 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂 |
| SG11201810270SA (en) | 2017-09-29 | 2019-04-29 | Chugai Pharmaceutical Co Ltd | Multispecific antigen-binding molecules having blood coagulation factor viii (fviii) cofactor function-substituting activity and pharmaceutical formulations containing such a molecule as an active ing |
| WO2019078344A1 (ja) | 2017-10-20 | 2019-04-25 | 学校法人兵庫医科大学 | 抗ｉｌ－６受容体抗体を含有する術後の癒着を抑制するための医薬組成物 |
| MX2020003472A (es) | 2017-11-01 | 2020-08-03 | Chugai Pharmaceutical Co Ltd | Variante e isoforma de anticuerpos con actividad biologica reducida. |
| CA3083971A1 (en) * | 2017-11-30 | 2019-06-06 | Bio-Thera Solutions, Ltd. | Liquid formulation of humanized antibody for treating il-6 related diseases |
| TWI822728B (zh) | 2018-01-31 | 2023-11-21 | 加藤元一 | 含有il-6抑制劑的哮喘治療劑 |
| US20210101929A1 (en) * | 2018-04-16 | 2021-04-08 | Merck Patent Gmbh | Method for stabilizing protein comprising formulations by using a meglumine salt |
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| KR102750533B1 (ko) | 2019-01-29 | 2025-01-06 | 현대자동차 주식회사 | 엔진 시스템 |
| KR20210144795A (ko) | 2019-03-29 | 2021-11-30 | 추가이 세이야쿠 가부시키가이샤 | 항il-6 수용체 항체를 함유하는 bbb 기능 저하의 억제제 |
| TWI868126B (zh) | 2019-04-17 | 2025-01-01 | 國立大學法人廣島大學 | 以組合投予il-6 抑制劑與ccr2 抑制劑為特徵之泌尿器官癌的治療劑 |
| MA55750A (fr) * | 2019-04-23 | 2022-03-02 | Sanofi Sa | Formulations d'anticorps stables et à faible viscosité et leurs utilisations |
| JP2022536855A (ja) | 2019-06-19 | 2022-08-19 | シルバーバック セラピューティックス インコーポレイテッド | 抗メソテリン抗体およびそのイムノコンジュゲート |
| CN112206319B (zh) * | 2019-07-12 | 2025-03-18 | 鲁南制药集团股份有限公司 | 一种cd47单克隆抗体制剂及其制备方法 |
| WO2021011404A1 (en) * | 2019-07-12 | 2021-01-21 | Contrafect Corporation | Therapeutic protein formulations comprising antibodies and uses thereof |
| TW202207984A (zh) | 2019-10-11 | 2022-03-01 | 日商中外製藥股份有限公司 | 用於後天性血友病a之預防及/或治療之醫藥組成物、及包含該醫藥組成物之製品 |
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