ES2985395T3 - Formulaciones líquidas que contienen anticuerpos estabilizados - Google Patents
Formulaciones líquidas que contienen anticuerpos estabilizados Download PDFInfo
- Publication number
- ES2985395T3 ES2985395T3 ES21159453T ES21159453T ES2985395T3 ES 2985395 T3 ES2985395 T3 ES 2985395T3 ES 21159453 T ES21159453 T ES 21159453T ES 21159453 T ES21159453 T ES 21159453T ES 2985395 T3 ES2985395 T3 ES 2985395T3
- Authority
- ES
- Spain
- Prior art keywords
- formulations containing
- liquid formulations
- containing stabilized
- stabilized antibodies
- antibodies
- 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.)
- Active
Links
- 239000012669 liquid formulation Substances 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
-
- 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)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (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 |
---|---|
ES2985395T3 true ES2985395T3 (es) | 2024-11-05 |
Family
ID=44306888
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES21159453T Active ES2985395T3 (es) | 2010-01-20 | 2011-01-20 | Formulaciones líquidas que contienen anticuerpos estabilizados |
ES11734694.0T Active ES2671224T3 (es) | 2010-01-20 | 2011-01-20 | Formulaciones líquidas que contienen anticuerpos estabilizados |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES11734694.0T Active ES2671224T3 (es) | 2010-01-20 | 2011-01-20 | Formulaciones líquidas que contienen anticuerpos estabilizados |
Country Status (22)
Country | Link |
---|---|
US (3) | US10022319B2 (es) |
EP (4) | EP4442277A3 (es) |
JP (2) | JP5939799B2 (es) |
KR (4) | KR20190011326A (es) |
CN (2) | CN102858366B (es) |
AR (2) | AR080428A1 (es) |
AU (5) | AU2011208075B2 (es) |
BR (1) | BR112012018023A2 (es) |
CA (2) | CA3115615C (es) |
DK (1) | DK2526963T3 (es) |
ES (2) | ES2985395T3 (es) |
IL (3) | IL296486A (es) |
MX (1) | MX349560B (es) |
MY (1) | MY185867A (es) |
NZ (1) | NZ601374A (es) |
PL (2) | PL2526963T3 (es) |
RU (1) | RU2653447C2 (es) |
SG (2) | SG10202003196SA (es) |
TR (1) | TR201807401T4 (es) |
TW (2) | TWI505838B (es) |
WO (1) | WO2011090088A1 (es) |
ZA (1) | ZA201205446B (es) |
Families Citing this family (74)
Publication number | Priority date | Publication date | Assignee | Title |
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GB2401040A (en) | 2003-04-28 | 2004-11-03 | Chugai Pharmaceutical Co Ltd | Method for treating interleukin-6 related diseases |
JP5620626B2 (ja) | 2005-03-31 | 2014-11-05 | 中外製薬株式会社 | 会合制御によるポリペプチド製造方法 |
DK2009101T3 (en) | 2006-03-31 | 2018-01-15 | Chugai Pharmaceutical Co Ltd | Antibody modification method for purification of a bispecific antibody |
CA2647846C (en) | 2006-03-31 | 2016-06-21 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
JP5334319B2 (ja) | 2007-09-26 | 2013-11-06 | 中外製薬株式会社 | Cdrのアミノ酸置換により抗体の等電点を改変する方法 |
PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
SG10201510640QA (en) | 2009-10-26 | 2016-01-28 | Hoffmann La Roche | Method For The Production Of A Glycosylated Immunoglobulin |
AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
EP2638067A2 (en) | 2010-11-08 | 2013-09-18 | Genentech, Inc. | Subcutaneously administered anti-il-6 receptor antibody |
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 |
JP6363017B2 (ja) | 2011-09-01 | 2018-07-25 | 中外製薬株式会社 | 限外ろ過によって高度に濃縮された抗体を含む組成物を調製するための方法 |
US9731028B2 (en) | 2012-04-04 | 2017-08-15 | Polaris Group | Methods of treatment with arginine deiminase |
US9969794B2 (en) | 2012-05-10 | 2018-05-15 | Visterra, Inc. | HA binding agents |
WO2014010586A1 (ja) * | 2012-07-10 | 2014-01-16 | 武田薬品工業株式会社 | 注射用製剤 |
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 |
CN107513105B (zh) | 2013-05-30 | 2019-08-16 | 基尼克萨制药有限公司 | 制瘤素m受体抗原结合蛋白 |
MX2016003616A (es) | 2013-09-27 | 2016-07-21 | Chugai Pharmaceutical Co Ltd | Metodo para producir heteromultimeros de polipeptidos. |
CN106061468B (zh) | 2013-11-29 | 2020-10-02 | 阿雷斯贸易股份有限公司 | 包含TNFR和Fc区的融合蛋白的液体制剂 |
EP3119885B1 (en) | 2014-03-17 | 2021-06-02 | 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 |
RU2017111228A (ru) * | 2014-10-18 | 2018-11-21 | Пфайзер Инк. | Композиции антитела против IL-7R |
WO2016068333A1 (ja) * | 2014-10-30 | 2016-05-06 | 中外製薬株式会社 | シリンジキャップを具備した、針付プレフィルドシリンジ製剤 |
EP3224359B1 (en) * | 2014-11-25 | 2023-10-25 | Bio-Rad Laboratories, Inc. | Arginine improves polymerase storage stability |
CN107249637A (zh) | 2015-02-27 | 2017-10-13 | 中外制药株式会社 | 用于治疗il‑6相关疾病的组合物 |
EP3279216A4 (en) | 2015-04-01 | 2019-06-19 | Chugai Seiyaku Kabushiki Kaisha | PROCESS FOR PREPARING POLYPEPTIDE HETERO OLIGOMER |
SG11201803989WA (en) | 2015-12-28 | 2018-06-28 | Chugai Pharmaceutical Co Ltd | Method for promoting efficiency of purification of fc region-containing polypeptide |
EP3402470A4 (en) * | 2016-01-12 | 2019-11-13 | Dr. Reddy's Laboratories Limited | STABLE PHARMACEUTICAL COMPOSITION |
ES2983242T3 (es) * | 2016-01-13 | 2024-10-22 | Genmab As | Formulación para anticuerpo y conjugado de fármaco del mismo |
AU2017222564A1 (en) * | 2016-02-24 | 2018-09-06 | 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 |
CN116059353A (zh) * | 2016-04-28 | 2023-05-05 | 中外制药株式会社 | 含抗体制剂 |
US11352438B2 (en) | 2016-09-06 | 2022-06-07 | 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 |
BR112019018022A2 (pt) * | 2017-03-01 | 2020-06-02 | Medimmune Limited | Formulações de anticorpos monoclonais |
WO2018179138A1 (ja) * | 2017-03-29 | 2018-10-04 | 持田製薬株式会社 | 抗体含有液体製剤 |
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 |
TWI775827B (zh) | 2017-03-31 | 2022-09-01 | 日商明治製菓藥業股份有限公司 | 水性製劑及裝入注射器之水性製劑以及抗體蛋白去凝集劑及抗體蛋白去凝集方法 |
WO2018191414A1 (en) | 2017-04-11 | 2018-10-18 | Kiniksa Pharmaceuticals, Ltd. | Stable anti-osmr antibody formulation |
MA48461A (fr) * | 2017-04-28 | 2020-03-04 | Amgen Inc | Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation |
BR112019022873A8 (pt) | 2017-05-02 | 2023-04-11 | Merck Sharp & Dohme | Formulação, e, vaso ou dispositivo de injeção. |
JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
KR102078957B1 (ko) | 2017-09-29 | 2020-02-20 | 추가이 세이야쿠 가부시키가이샤 | 혈액 응고 제 viii 인자(fviii) 보인자 기능 대체 활성을 갖는 다중특이성 항원 결합 분자 및 당해 분자를 유효 성분으로서 함유하는 약학적 제제 |
US11692037B2 (en) | 2017-10-20 | 2023-07-04 | Hyogo College Of Medicine | Anti-IL-6 receptor antibody-containing medicinal composition for preventing post-surgical adhesion |
MX2020005630A (es) * | 2017-11-30 | 2020-08-20 | Bio Thera Solutions Ltd | Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6. |
JP7458790B2 (ja) | 2018-01-31 | 2024-04-01 | 元一 加藤 | Il-6阻害剤を含有する喘息の治療剤 |
BR112020020910A2 (pt) * | 2018-04-16 | 2021-01-26 | Merck Patent Gmbh | método para estabilização de formulações compreendendo proteína para uso de sal meglumina |
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CA3115708A1 (en) * | 2018-10-18 | 2020-04-23 | Merck Sharp & Dohme Corp. | Formulations of anti-rsv antibodies and methods of use thereof |
MX2021005015A (es) * | 2018-10-31 | 2021-07-21 | Richter Gedeon Nyrt | Formulaciones farmaceuticas acuosas. |
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US20220220210A1 (en) | 2019-03-29 | 2022-07-14 | Chugai Seiyaku Kabushiki Kaisha | Anti-il-6 receptor antibody-containing inhibitor for inhibiting deterioration of bbb function |
EP3957324A4 (en) | 2019-04-17 | 2023-02-08 | Hiroshima University | THERAPEUTIC AGENT FOR UROLOGICAL CANCER CHARACTERIZED IN THAT IT IS ADMINISTERED WITH AN IL-6 INHIBITOR AND A CCR2 INHIBITOR IN COMBINATION |
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TWI745114B (zh) | 2019-10-11 | 2021-11-01 | 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 |
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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AU2021281152A1 (en) * | 2020-05-28 | 2022-12-22 | Kashiv Biosciences, Llc | An improved process of storing and preparing the protein |
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CN116209678A (zh) | 2020-07-01 | 2023-06-02 | 安尔士制药公司 | 抗asgr1抗体缀合物及其用途 |
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CN112798720B (zh) * | 2021-01-11 | 2022-04-19 | 苏州药明生物技术有限公司 | 组氨酸缓冲液在减少蛋白聚体中的应用 |
IL305793A (en) | 2021-03-12 | 2023-11-01 | Hoffmann La Roche | A pharmaceutical preparation for the treatment or prevention of myasthenia gravis |
CN117858722A (zh) * | 2021-08-18 | 2024-04-09 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
USD987969S1 (en) * | 2022-02-24 | 2023-06-06 | L'atelier De Chaussures, S.L | Heel for footwear |
CN117007791B (zh) * | 2023-07-18 | 2024-08-09 | 广州市进德生物科技有限公司 | 一种辣根过氧化物酶偶联物稀释保存液 |
JP7545553B1 (ja) | 2023-10-13 | 2024-09-04 | シャープ株式会社 | 送風装置 |
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