JOP20170017B1 - تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص - Google Patents
تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاصInfo
- Publication number
- JOP20170017B1 JOP20170017B1 JOP/2017/0017A JOP20170017A JOP20170017B1 JO P20170017 B1 JOP20170017 B1 JO P20170017B1 JO P20170017 A JOP20170017 A JO P20170017A JO P20170017 B1 JOP20170017 B1 JO P20170017B1
- Authority
- JO
- Jordan
- Prior art keywords
- antibody constructs
- pharmaceutical composition
- bispecific antibody
- constructs
- cyclodextrins
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- 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
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2315/00—Details relating to the membrane module operation
- B01D2315/16—Diafiltration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Dermatology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
يعمل هذا الاختراع على إعداد تركيبات صيدلية جديدة وثابتة تتضمن تركيبات جسم مضاد ثنائية الاختصاص ذات سلسلة واحدة، دكسترينات حلقية ومحلول منظم.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662286552P | 2016-01-25 | 2016-01-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JOP20170017B1 true JOP20170017B1 (ar) | 2021-08-17 |
Family
ID=57960407
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JOP/2017/0017A JOP20170017B1 (ar) | 2016-01-25 | 2017-01-24 | تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص |
Country Status (33)
| Country | Link |
|---|---|
| US (2) | US11419933B2 (ar) |
| EP (1) | EP3408295B1 (ar) |
| JP (1) | JP7168451B2 (ar) |
| KR (1) | KR102843708B1 (ar) |
| CN (1) | CN109071657B (ar) |
| AR (1) | AR107444A1 (ar) |
| AU (1) | AU2017213050B2 (ar) |
| CA (1) | CA3011082A1 (ar) |
| CL (1) | CL2018001953A1 (ar) |
| CO (1) | CO2018008754A2 (ar) |
| CR (1) | CR20180408A (ar) |
| DK (1) | DK3408295T5 (ar) |
| EA (1) | EA201891694A1 (ar) |
| ES (1) | ES2959257T3 (ar) |
| FI (1) | FI3408295T3 (ar) |
| HU (1) | HUE063319T2 (ar) |
| IL (1) | IL260753B2 (ar) |
| JO (1) | JOP20170017B1 (ar) |
| LT (1) | LT3408295T (ar) |
| MA (1) | MA46820A (ar) |
| MX (1) | MX2018009060A (ar) |
| MY (1) | MY207039A (ar) |
| PH (1) | PH12018501419B1 (ar) |
| PL (1) | PL3408295T3 (ar) |
| PT (1) | PT3408295T (ar) |
| SG (1) | SG11201805738QA (ar) |
| SI (1) | SI3408295T1 (ar) |
| TN (1) | TN2018000260A1 (ar) |
| TW (1) | TWI797073B (ar) |
| UA (1) | UA126279C2 (ar) |
| UY (1) | UY37092A (ar) |
| WO (1) | WO2017129585A1 (ar) |
| ZA (1) | ZA201804354B (ar) |
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| EP3050963B1 (en) | 2005-03-31 | 2019-09-18 | Chugai Seiyaku Kabushiki Kaisha | Process for production of polypeptide by regulation of assembly |
| ES2892925T3 (es) | 2006-03-31 | 2022-02-07 | Chugai Pharmaceutical Co Ltd | Métodos para controlar la farmacocinética en sangre de anticuerpos |
| CN101874042B9 (zh) | 2007-09-26 | 2019-01-01 | 中外制药株式会社 | 利用cdr的氨基酸取代来改变抗体等电点的方法 |
| NL2011406C2 (en) | 2013-09-06 | 2015-03-10 | Bionovion Holding B V | Method for obtaining april-binding peptides, process for producing the peptides, april-binding peptides obtainable with said method/process and use of the april-binding peptides. |
| JP6534615B2 (ja) | 2013-09-27 | 2019-06-26 | 中外製薬株式会社 | ポリペプチド異種多量体の製造方法 |
| 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 |
| NL2014108B1 (en) | 2015-01-09 | 2016-09-30 | Aduro Biotech Holdings Europe B V | Altered april binding antibodies. |
| 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 |
| TWI796283B (zh) * | 2015-07-31 | 2023-03-21 | 德商安美基研究(慕尼黑)公司 | Msln及cd3抗體構築體 |
| EP3359555B1 (en) | 2015-10-07 | 2023-12-20 | Apellis Pharmaceuticals, Inc. | Dosing regimens |
| US20200270363A1 (en) | 2015-12-25 | 2020-08-27 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| CN108368166B (zh) | 2015-12-28 | 2023-03-28 | 中外制药株式会社 | 提高含fc区多肽纯化效率的方法 |
| JOP20170017B1 (ar) * | 2016-01-25 | 2021-08-17 | Amgen Res Munich Gmbh | تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص |
| EP3411404B1 (en) | 2016-02-03 | 2022-11-09 | Amgen Research (Munich) GmbH | Psma and cd3 bispecific t cell engaging antibody constructs |
| MA44780A (fr) | 2016-04-28 | 2019-03-06 | Chugai Pharmaceutical Co Ltd | Préparation contenant un anticorps |
| KR102591955B1 (ko) | 2016-07-29 | 2023-10-19 | 추가이 세이야쿠 가부시키가이샤 | 증강된 fviii 보인자 기능 대체 활성을 갖는 이중특이성 항체 |
| RU2766233C2 (ru) | 2016-09-06 | 2022-02-10 | Чугаи Сейяку Кабусики Кайся | Способы применения биспецифического антитела, которое распознает фактор свертывания ix и/или активированный фактор свертывания ix и фактор свертывания x и/или активированный фактор свертывания x |
| TN2019000225A1 (en) * | 2017-02-02 | 2021-01-07 | Amgen Res Munich Gmbh | Low ph pharmaceutical composition comprising t cell engaging antibody constructs |
| CN106800598B (zh) * | 2017-02-09 | 2020-08-07 | 广州桂雨生物科技有限公司 | 一种抗体保存液及其制备方法 |
| 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 |
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| AR113142A1 (es) | 2017-09-29 | 2020-01-29 | Chugai Pharmaceutical Co Ltd | Moléculas de unión al antígeno multiespecíficas que tienen actividad de sustitución de la función de cofactor del factor viii de coagulación de sangre (fviii), y formulaciones farmacéuticas que contienen dicha molécula como ingrediente activo |
| AU2018361430B2 (en) | 2017-11-01 | 2025-08-14 | Chugai Seiyaku Kabushiki Kaisha | Antibody variant and isoform with lowered biological activity |
| AU2018386304B2 (en) | 2017-12-15 | 2023-12-07 | Apellis Pharmaceuticals, Inc. | Dosing regimens and related compositions and methods |
| UY38080A (es) * | 2018-02-08 | 2019-08-30 | Amgen Inc | FORMULACIÓN FARMACÉUTICA DE pH BAJO |
| BR112020015052A2 (pt) * | 2018-02-09 | 2020-12-08 | Genmab A/S | Composição farmacêutica, uso da composição farmacêutica, métodos para tratar câncer em um sujeito, para preparar uma composição farmacêutica e para preparar uma forma de dosagem unitária, forma de dosagem unitária, recipiente, e, kit-de-partes |
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