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 [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IG], 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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Mycology (AREA)
- Microbiology (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) | EP4442277A3 (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) | CA3115615C (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) | SG10202003196SA (pl) |
| TR (1) | TR201807401T4 (pl) |
| TW (2) | TWI505838B (pl) |
| WO (1) | WO2011090088A1 (pl) |
| ZA (1) | ZA201205446B (pl) |
Families Citing this family (89)
| 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 |
| TWI544076B (zh) | 2005-03-31 | 2016-08-01 | 中外製藥股份有限公司 | A method of manufacturing a polypeptide that controls assembly |
| JP5144499B2 (ja) | 2006-03-31 | 2013-02-13 | 中外製薬株式会社 | 二重特異性抗体を精製するための抗体改変方法 |
| CA2647846C (en) | 2006-03-31 | 2016-06-21 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
| RU2510400C9 (ru) | 2007-09-26 | 2014-07-20 | Чугаи Сейяку Кабусики Кайся | Способ модификации изоэлектрической точки антитела с помощью аминокислотных замен в cdr |
| PE20091174A1 (es) † | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| HUE067718T2 (hu) | 2009-10-26 | 2024-11-28 | Hoffmann La Roche | Eljárás glikozilált immunglobulin elõállítására |
| TWI505838B (zh) | 2010-01-20 | 2015-11-01 | 中外製藥股份有限公司 | Stabilized antibody solution containing |
| KR102116202B1 (ko) | 2010-11-08 | 2020-05-28 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| KR101398290B1 (ko) | 2010-11-17 | 2014-05-22 | 추가이 세이야쿠 가부시키가이샤 | 혈액응고 제viii 인자의 기능을 대체하는 기능을 갖는 다중특이성 항원 결합 분자 |
| EP2735315B1 (en) | 2011-07-19 | 2019-10-02 | Chugai Seiyaku Kabushiki Kaisha | Stable protein-containing preparation containing argininamide or valinamide |
| SG11201400260TA (en) | 2011-09-01 | 2014-03-28 | Chugai Pharmaceutical Co Ltd | Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration |
| TW201735943A (zh) | 2012-04-04 | 2017-10-16 | 普拉瑞斯集團 | 利用精胺酸去亞胺酶之治療方法 |
| US9969794B2 (en) | 2012-05-10 | 2018-05-15 | Visterra, Inc. | HA binding agents |
| EP2873422A4 (en) * | 2012-07-10 | 2015-12-30 | Takeda Pharmaceutical | PHARMACEUTICAL PREPARATION FOR INJECTION |
| WO2014054744A1 (ja) * | 2012-10-03 | 2014-04-10 | 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 |
| IL317484A (en) | 2013-05-30 | 2025-02-01 | Kiniksa Pharmaceuticals Ltd | Oncostatin M receptor antigen-binding proteins |
| AU2014325063B2 (en) | 2013-09-27 | 2019-10-31 | Chugai Seiyaku Kabushiki Kaisha | Method for producing polypeptide heteromultimer |
| KR101712245B1 (ko) * | 2013-11-29 | 2017-03-06 | 아레스 트레이딩 에스.에이. | TNFR 및 면역글로블린 Fc 영역을 포함하는 융합 단백질을 포함하는 액상 제제 |
| US10323095B2 (en) | 2014-03-17 | 2019-06-18 | Mitsubishi Tanabe Pharma Corporation | Antibody-fynomer conjugates |
| TWI831106B (zh) | 2014-06-20 | 2024-02-01 | 日商中外製藥股份有限公司 | 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 |
| 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 |
| 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 |
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| EP3224359B1 (en) * | 2014-11-25 | 2023-10-25 | Bio-Rad Laboratories, Inc. | Arginine improves polymerase storage stability |
| TWI805046B (zh) | 2015-02-27 | 2023-06-11 | 日商中外製藥股份有限公司 | Il-6受體抗體用於製備醫藥組成物的用途 |
| JP7082484B2 (ja) | 2015-04-01 | 2022-06-08 | 中外製薬株式会社 | ポリペプチド異種多量体の製造方法 |
| US20200270363A1 (en) | 2015-12-25 | 2020-08-27 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| AU2016381992B2 (en) | 2015-12-28 | 2024-01-04 | Chugai Seiyaku Kabushiki Kaisha | Method for promoting efficiency of purification of Fc region-containing polypeptide |
| BR112018014123A2 (pt) * | 2016-01-12 | 2018-12-11 | Dr. Reddy's Laboratories Limited | formulação farmacêutica aquosa estável. |
| US12115227B2 (en) * | 2016-01-13 | 2024-10-15 | Genmab A/S | Formulation for antibody and drug conjugate thereof |
| EP3419663A1 (en) * | 2016-02-24 | 2019-01-02 | Visterra, Inc. | Formulations of antibody molecules to influenza virus |
| EP3443346B1 (en) * | 2016-04-13 | 2023-08-30 | Medimmune, LLC | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| CR20180554A (es) * | 2016-04-28 | 2019-01-10 | Chugai Pharmaceutical Co Ltd | Preparaciones que contienen anticuerpos |
| 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 |
| EP3492496A4 (en) | 2016-07-29 | 2020-07-29 | Chugai Seiyaku Kabushiki Kaisha | BISPECIFIC ANTIBODIES PRESENTING AN INCREASED ALTERNATIVE FUNCTIONAL ACTIVITY OF COFACTOR FVIII |
| AU2017325240B9 (en) | 2016-09-06 | 2025-02-13 | Chugai Seiyaku Kabushiki Kaisha | Methods of using a bispecific antibody that recognizes coagulation factor IX and/or activated coagulation factor IX and coagulation factor X and/or activated coagulation factor X |
| EP3534963B1 (en) | 2016-11-02 | 2024-04-17 | Polaris Group | Formulations of pegylated arginine deiminase |
| CN110366429B (zh) * | 2017-03-01 | 2024-10-11 | 免疫医疗有限公司 | 单克隆抗体的配制品 |
| WO2018179138A1 (ja) * | 2017-03-29 | 2018-10-04 | 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 |
| CN110461358A (zh) | 2017-03-31 | 2019-11-15 | 公立大学法人奈良县立医科大学 | 可用于预防和/或治疗凝血因子ⅸ异常、包含代替凝血因子ⅷ的功能的多特异性抗原结合分子的药物组合物 |
| MA53466A (fr) * | 2017-04-11 | 2021-09-08 | Kiniksa Pharmaceuticals Ltd | Formulation stable d'anticorps anti-osmr |
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| EP3618871A4 (en) | 2017-05-02 | 2021-01-06 | Merck Sharp & Dohme Corp. | FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| CN111108202B (zh) | 2017-09-29 | 2024-10-22 | 中外制药株式会社 | 具有凝血因子viii(fviii)辅因子功能替代活性的多特异性抗原结合分子及含有所述分子作为活性成分的药物制剂 |
| KR102771895B1 (ko) | 2017-10-20 | 2025-02-21 | 가꼬우호우징 효고 이카다이가쿠 | 항il-6 수용체 항체를 함유하는 수술 후의 유착을 억제하기 위한 의약 조성물 |
| CN119161488A (zh) | 2017-11-01 | 2024-12-20 | 中外制药株式会社 | 具有降低的生物活性的抗体变体和同种型 |
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| JPWO2020202839A1 (pl) | 2019-03-29 | 2020-10-08 | ||
| JP7501876B2 (ja) | 2019-04-17 | 2024-06-18 | 国立大学法人広島大学 | Ｉｌ－６阻害剤及びｃｃｒ２阻害剤を組み合わせて投与することを特徴とする泌尿器がんの治療剤 |
| JP7671697B2 (ja) * | 2019-04-23 | 2025-05-02 | サノフイ | 安定な低粘度抗体製剤およびその使用 |
| US20220249685A1 (en) | 2019-06-19 | 2022-08-11 | Silverback Therapeutics, Inc. | Anti-mesothelin antibodies and immunoconjugates thereof |
| 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 |
| WO2021070885A1 (ja) | 2019-10-11 | 2021-04-15 | 中外製薬株式会社 | 後天性血友病ａの予防および／または治療に用いられる医薬組成物、および当該医薬組成物を含む製品 |
| EP3808777A1 (en) | 2019-10-16 | 2021-04-21 | Glenmark Specialty S.A. | Stable liquid antibody formulations |
| JP7525254B2 (ja) * | 2019-11-14 | 2024-07-30 | ミヨシ油脂株式会社 | 有機アンモニウム塩とそれを用いた生体試料処理剤 |
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| GB201008358D0 (en) | Formulations | |
| GB201007702D0 (en) | Formulations | |
| GB201007959D0 (en) | Formulations | |
| GB201012589D0 (en) | Formulations | |
| GB201018645D0 (en) | Formulations | |
| GB201018647D0 (en) | Formulations | |
| GB201018648D0 (en) | Formulations |