BR112018067792A2 - preparação contendo o anticorpo - Google Patents
preparação contendo o anticorpoInfo
- Publication number
- BR112018067792A2 BR112018067792A2 BR112018067792-2A BR112018067792A BR112018067792A2 BR 112018067792 A2 BR112018067792 A2 BR 112018067792A2 BR 112018067792 A BR112018067792 A BR 112018067792A BR 112018067792 A2 BR112018067792 A2 BR 112018067792A2
- Authority
- BR
- Brazil
- Prior art keywords
- antibody
- preparation containing
- relates
- present
- mentioned
- Prior art date
Links
Classifications
-
- 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
- C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
-
- 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
- A61K47/10—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
- A61K47/16—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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- 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
- 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
-
- 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
-
- 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
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
a presente invenção refere-se a formulações de soluções contendo anticorpos estáveis nas quais a formação de agregado de emicizumab (ace910) que é um anticorpo biespecífico de forma funcional substituindo fviii, é suprimida. especificamente, a presente invenção refere-se às formulações de soluções contendo anticorpo acima mencionadas de ph 4,5 a 6,5 que contêm anticorpo biespecífico acima mencionado a 20 a 180 mg/ml, tampão de histidina-aspartato a 10 mm a 40 mm, poloxâmero 188 a 0,2 a 1 mg/ml e arginina a 100 mm a 300 mm.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2016-090590 | 2016-04-28 | ||
| JP2016090590 | 2016-04-28 | ||
| PCT/JP2017/016658 WO2017188356A1 (ja) | 2016-04-28 | 2017-04-27 | 抗体含有製剤 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112018067792A2 true BR112018067792A2 (pt) | 2019-02-12 |
Family
ID=60160798
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112018067792-2A BR112018067792A2 (pt) | 2016-04-28 | 2017-04-27 | preparação contendo o anticorpo |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20210189006A1 (pt) |
| EP (1) | EP3449940A4 (pt) |
| JP (3) | JP7320943B2 (pt) |
| KR (1) | KR102456742B1 (pt) |
| CN (2) | CN108883178B (pt) |
| AR (1) | AR108240A1 (pt) |
| AU (1) | AU2017255077B2 (pt) |
| BR (1) | BR112018067792A2 (pt) |
| CA (1) | CA3016301A1 (pt) |
| CL (1) | CL2018003022A1 (pt) |
| CR (1) | CR20180554A (pt) |
| HK (1) | HK1257953A1 (pt) |
| IL (1) | IL262589A (pt) |
| MA (1) | MA44780A (pt) |
| MX (1) | MX2018012648A (pt) |
| PE (1) | PE20181889A1 (pt) |
| RU (1) | RU2748046C2 (pt) |
| SG (1) | SG11201807765PA (pt) |
| TW (2) | TW202402326A (pt) |
| UA (1) | UA126900C2 (pt) |
| WO (1) | WO2017188356A1 (pt) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| JP5624276B2 (ja) | 2006-03-31 | 2014-11-12 | 中外製薬株式会社 | 抗体の血中動態を制御する方法 |
| CN105177091A (zh) | 2006-03-31 | 2015-12-23 | 中外制药株式会社 | 用于纯化双特异性抗体的抗体修饰方法 |
| EP3689912A1 (en) | 2007-09-26 | 2020-08-05 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substitution in cdr |
| TWI505838B (zh) | 2010-01-20 | 2015-11-01 | Chugai Pharmaceutical Co Ltd | Stabilized antibody solution containing |
| TWI629355B (zh) | 2010-11-17 | 2018-07-11 | 中外製藥股份有限公司 | 具有替代血液凝固第ｖｉｉｉ因子之功能的多重專一性抗原結合分子 |
| RU2730594C2 (ru) | 2013-09-27 | 2020-08-24 | Чугаи Сейяку Кабусики Кайся | Способ получения полипептидного гетеромультимера |
| 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 |
| EP3279216A4 (en) | 2015-04-01 | 2019-06-19 | Chugai Seiyaku Kabushiki Kaisha | PROCESS FOR PREPARING POLYPEPTIDE HETERO OLIGOMER |
| FR3038517B1 (fr) | 2015-07-06 | 2020-02-28 | Laboratoire Francais Du Fractionnement Et Des Biotechnologies | Utilisation de fragments fc modifies en immunotherapie |
| US20200270363A1 (en) | 2015-12-25 | 2020-08-27 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| JP7219005B2 (ja) | 2015-12-28 | 2023-02-07 | 中外製薬株式会社 | Ｆｃ領域含有ポリペプチドの精製を効率化するための方法 |
| 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 |
| TW202423960A (zh) | 2017-09-29 | 2024-06-16 | 日商中外製藥股份有限公司 | 具有第viii凝血因子(fviii)輔因子機能替代活性的多重特異性抗原結合分子及含有此分子作為有效成分之藥學製劑 |
| FR3082427B1 (fr) | 2018-06-14 | 2020-09-25 | Lab Francais Du Fractionnement | Combinaison de facteur vii et d'un anticorps bispecifique anti-facteurs ix et x |
| EP3849513A1 (en) * | 2018-09-11 | 2021-07-21 | Ichnos Sciences SA | Compositions comprising a bispecific antibody, bufffer and one or more stabilizing agents |
| CN111665352B (zh) * | 2020-06-23 | 2024-05-17 | 广州市丹蓝生物科技有限公司 | 一种储存剂及由其制备的抗体溶液制剂及其应用 |
| EP4272756A4 (en) * | 2021-02-05 | 2024-12-11 | Bio-Thera Solutions, Ltd. | ANTI-IL-5 ANTIBODY FORMULATION, MANUFACTURING METHOD AND USE THEREOF |
| IL311956A (en) * | 2021-10-08 | 2024-06-01 | Chugai Pharmaceutical Co Ltd | Method for preparing prefilled syringe formulation |
| CN118414166A (zh) | 2021-12-01 | 2024-07-30 | 中外制药株式会社 | 含有抗体的制剂的制备方法 |
| CN114544839B (zh) * | 2022-01-20 | 2024-08-20 | 未名生物医药有限公司 | 一种抗人神经生长因子抗体的电荷变异体检测方法 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5530101A (en) * | 1988-12-28 | 1996-06-25 | Protein Design Labs, Inc. | Humanized immunoglobulins |
| EP2116265B1 (en) | 2000-10-12 | 2020-12-23 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| AU2003271174A1 (en) | 2003-10-10 | 2005-04-27 | Chugai Seiyaku Kabushiki Kaisha | Double specific antibodies substituting for functional protein |
| US20100003254A1 (en) | 2005-04-08 | 2010-01-07 | Chugai Seiyaku Kabushiki Kaisha | Antibody Substituting for Function of Blood Coagulation Factor VIII |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| TWI505838B (zh) | 2010-01-20 | 2015-11-01 | Chugai Pharmaceutical Co Ltd | Stabilized antibody solution containing |
| TWI629355B (zh) | 2010-11-17 | 2018-07-11 | 中外製藥股份有限公司 | 具有替代血液凝固第ｖｉｉｉ因子之功能的多重專一性抗原結合分子 |
| BR112014019667B1 (pt) | 2012-03-08 | 2022-11-01 | F. Hoffmann-La Roche Ag | Formulação farmacêutica líquida estável de anticorpo abeta |
| 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 |
-
2017
- 2017-04-27 AU AU2017255077A patent/AU2017255077B2/en active Active
- 2017-04-27 JP JP2018514687A patent/JP7320943B2/ja active Active
- 2017-04-27 UA UAA201811471A patent/UA126900C2/uk unknown
- 2017-04-27 EP EP17789638.8A patent/EP3449940A4/en active Pending
- 2017-04-27 TW TW112137276A patent/TW202402326A/zh unknown
- 2017-04-27 US US16/093,495 patent/US20210189006A1/en active Pending
- 2017-04-27 AR ARP170101082A patent/AR108240A1/es unknown
- 2017-04-27 MX MX2018012648A patent/MX2018012648A/es unknown
- 2017-04-27 KR KR1020187033718A patent/KR102456742B1/ko active Active
- 2017-04-27 SG SG11201807765PA patent/SG11201807765PA/en unknown
- 2017-04-27 PE PE2018001975A patent/PE20181889A1/es unknown
- 2017-04-27 CR CR20180554A patent/CR20180554A/es unknown
- 2017-04-27 WO PCT/JP2017/016658 patent/WO2017188356A1/ja active Application Filing
- 2017-04-27 RU RU2018141173A patent/RU2748046C2/ru active
- 2017-04-27 TW TW106114061A patent/TWI820000B/zh active
- 2017-04-27 MA MA044780A patent/MA44780A/fr unknown
- 2017-04-27 CN CN201780020233.XA patent/CN108883178B/zh active Active
- 2017-04-27 CN CN202310130344.3A patent/CN116059353A/zh active Pending
- 2017-04-27 BR BR112018067792-2A patent/BR112018067792A2/pt unknown
- 2017-04-27 CA CA3016301A patent/CA3016301A1/en active Pending
-
2018
- 2018-10-24 CL CL2018003022A patent/CL2018003022A1/es unknown
- 2018-10-25 IL IL262589A patent/IL262589A/en unknown
-
2019
- 2019-01-09 HK HK19100315.7A patent/HK1257953A1/zh unknown
-
2021
- 2021-12-09 JP JP2021199702A patent/JP2022037069A/ja active Pending
-
2023
- 2023-08-08 JP JP2023129455A patent/JP7544932B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| UA126900C2 (uk) | 2023-02-22 |
| JP7320943B2 (ja) | 2023-08-04 |
| RU2018141173A3 (pt) | 2020-06-11 |
| MA44780A (fr) | 2019-03-06 |
| CN116059353A (zh) | 2023-05-05 |
| AU2017255077B2 (en) | 2024-05-16 |
| JP7544932B2 (ja) | 2024-09-03 |
| KR102456742B1 (ko) | 2022-10-19 |
| RU2748046C2 (ru) | 2021-05-19 |
| JP2022037069A (ja) | 2022-03-08 |
| JP2023145766A (ja) | 2023-10-11 |
| CR20180554A (es) | 2019-01-10 |
| US20210189006A1 (en) | 2021-06-24 |
| TW201737942A (zh) | 2017-11-01 |
| CA3016301A1 (en) | 2017-11-02 |
| CN108883178B (zh) | 2023-03-14 |
| TW202402326A (zh) | 2024-01-16 |
| JPWO2017188356A1 (ja) | 2019-03-07 |
| CL2018003022A1 (es) | 2019-01-18 |
| MX2018012648A (es) | 2019-01-30 |
| CN108883178A (zh) | 2018-11-23 |
| PE20181889A1 (es) | 2018-12-11 |
| AR108240A1 (es) | 2018-08-01 |
| HK1257953A1 (zh) | 2019-11-01 |
| EP3449940A4 (en) | 2020-01-22 |
| EP3449940A1 (en) | 2019-03-06 |
| KR20190003596A (ko) | 2019-01-09 |
| AU2017255077A1 (en) | 2018-10-04 |
| WO2017188356A1 (ja) | 2017-11-02 |
| SG11201807765PA (en) | 2018-10-30 |
| TWI820000B (zh) | 2023-11-01 |
| IL262589A (en) | 2018-12-31 |
| RU2018141173A (ru) | 2020-05-28 |
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