ES2564281T3 - Formulación de anticuerpos Abeta - Google Patents
Formulación de anticuerpos Abeta Download PDFInfo
- Publication number
- ES2564281T3 ES2564281T3 ES13707176.7T ES13707176T ES2564281T3 ES 2564281 T3 ES2564281 T3 ES 2564281T3 ES 13707176 T ES13707176 T ES 13707176T ES 2564281 T3 ES2564281 T3 ES 2564281T3
- Authority
- ES
- Spain
- Prior art keywords
- seq
- amino acid
- acid sequence
- abeta antibody
- sequence
- 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.)
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Classifications
-
- 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
- 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
- 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
- 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
- A61K47/34—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- 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)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Endocrinology (AREA)
- Inorganic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hospice & Palliative Care (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
Abstract
Una formulación farmacéutica líquida estable de anticuerpo que contiene: - de 50 mg/ml a 200 mg/ml de un anticuerpo Abeta, - del 0,01 % al 0,1% de un poloxámero, con preferencia del poloxámero 188, - de 5 mM a 50 mM de un tampón, - de 100 mM a 300 mM de un estabilizante, de un pH comprendido aprox. entre 4,5 y 7,0, en la que el anticuerpo Abeta es un anticuerpo monoclonal que contiene una cadena larga y una cadena corta, dicha cadena larga del anticuerpo Abeta contiene un dominio VH que contiene: - una CDR1 que contiene la secuencia de aminoácidos de la Seq. Id. No. 4, - una CDR2 que contiene la secuencia de aminoácidos de la Seq. Id. No. 5, - una secuencia CDR3 que contiene la secuencia de aminoácidos de la Seq. Id. No. 6. y dicha cadena corta del anticuerpo Abeta contiene un dominio VL que contiene: - una CDR1 que contiene la secuencia de aminoácidos de la Seq. Id. No. 7, - una CDR2 que contiene la secuencia de aminoácidos de la Seq. Id. No. 8, - una secuencia CDR3 que contiene la secuencia de aminoácidos de la Seq. Id. No. 9.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12158602 | 2012-03-08 | ||
| EP12158602 | 2012-03-08 | ||
| PCT/EP2013/054313 WO2013131866A1 (en) | 2012-03-08 | 2013-03-05 | Abeta antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2564281T3 true ES2564281T3 (es) | 2016-03-21 |
Family
ID=47780075
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES13707176.7T Active ES2564281T3 (es) | 2012-03-08 | 2013-03-05 | Formulación de anticuerpos Abeta |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20150030589A1 (es) |
| EP (1) | EP2822587B1 (es) |
| JP (1) | JP5859148B2 (es) |
| KR (1) | KR101666289B1 (es) |
| CN (1) | CN104159613B (es) |
| AR (2) | AR090272A1 (es) |
| AU (1) | AU2013229613B2 (es) |
| BR (1) | BR112014019667B1 (es) |
| CA (1) | CA2860543C (es) |
| CY (1) | CY1117363T1 (es) |
| DK (1) | DK2822587T3 (es) |
| ES (1) | ES2564281T3 (es) |
| HR (1) | HRP20160434T1 (es) |
| HU (1) | HUE028440T2 (es) |
| IL (1) | IL234120B (es) |
| MX (1) | MX351148B (es) |
| MY (1) | MY166045A (es) |
| NZ (1) | NZ626955A (es) |
| PL (1) | PL2822587T3 (es) |
| RS (1) | RS54644B1 (es) |
| RU (1) | RU2014140137A (es) |
| SG (1) | SG11201404481RA (es) |
| SI (1) | SI2822587T1 (es) |
| WO (1) | WO2013131866A1 (es) |
| ZA (1) | ZA201405103B (es) |
Families Citing this family (32)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101198698B (zh) | 2005-03-31 | 2014-03-19 | 中外制药株式会社 | 通过调节多肽缔合制备多肽的方法 |
| EP2009101B1 (en) | 2006-03-31 | 2017-10-25 | Chugai Seiyaku Kabushiki Kaisha | Antibody modification method for purifying bispecific antibody |
| CN104761637B (zh) | 2006-03-31 | 2021-10-15 | 中外制药株式会社 | 调控抗体血液动力学的方法 |
| 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 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| CN106267189B (zh) | 2010-10-06 | 2021-02-26 | 瑞泽恩制药公司 | 含有抗白介素-4受体(il-4r)的抗体的稳定制剂 |
| KR101962483B1 (ko) | 2010-11-17 | 2019-03-29 | 추가이 세이야쿠 가부시키가이샤 | 혈액응고 제viii 인자의 기능을 대체하는 기능을 갖는 다중특이성 항원 결합 분자 |
| MX385311B (es) | 2011-01-28 | 2025-03-18 | Sanofi Biotechnology | Anticuerpos humanos frente a pcsk9 para su uso en métodos de tratamiento de grupos concretos de pacientes. |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CN105764922B (zh) | 2013-09-27 | 2020-07-17 | 中外制药株式会社 | 多肽异源多聚体的制备方法 |
| EP3068803B1 (en) | 2013-11-12 | 2021-01-20 | Sanofi Biotechnology | Dosing regimens for use with pcsk9 inhibitors |
| 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 |
| US11142587B2 (en) | 2015-04-01 | 2021-10-12 | Chugai Seiyaku Kabushiki Kaisha | Method for producing polypeptide hetero-oligomer |
| CR20210429A (es) | 2015-06-24 | 2021-09-24 | Hoffmann La Roche | ANTICUERPOS ANTI-RECEPTOR DE TRANSFERRINA CON AFINIDAD DISEÑADA (Divisional 2017-0562) |
| KR20240172758A (ko) | 2015-08-18 | 2024-12-10 | 리제너론 파아마슈티컬스, 인크. | 지단백질 분리반출술을 경험하고 있는 고지혈증을 갖는 환자를 치료하기 위한 항-pcsk9 억제성 항체 |
| AR106189A1 (es) | 2015-10-02 | 2017-12-20 | Hoffmann La Roche | ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO |
| TWI819458B (zh) | 2015-10-02 | 2023-10-21 | 瑞士商赫孚孟拉羅股份公司 | 雙特異性抗‐人類cd20/人類轉鐵蛋白受體抗體及使用方法 |
| WO2017110980A1 (ja) | 2015-12-25 | 2017-06-29 | 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 |
| SG11201803989WA (en) | 2015-12-28 | 2018-06-28 | Chugai Pharmaceutical Co Ltd | Method for promoting efficiency of purification of fc region-containing polypeptide |
| ES3055961T3 (en) | 2016-04-28 | 2026-02-17 | Chugai Pharmaceutical Co Ltd | Antibody-containing preparation |
| CN109415444B (zh) | 2016-07-29 | 2024-03-01 | 中外制药株式会社 | 显示增加的备选fviii辅因子功能活性的双特异性抗体 |
| EP3509637B1 (en) | 2016-09-06 | 2024-11-27 | 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 |
| EP3603670A4 (en) | 2017-03-31 | 2021-03-10 | Public University Corporation Nara Medical University | MEDICAL COMPOSITION FOR THE PREVENTION AND / OR TREATMENT OF BLOOD CLOG FACTOR IX ANOMALY WITH A MULTI-SPECIFIC ANTIGIBINDING MOLECULAR FUNCTION OF BLOOD CLOTHING FACTOR VIII |
| ES3038711T3 (en) * | 2017-05-30 | 2025-10-14 | Morinaga Milk Industry Co Ltd | Acetic acid and/or an acetic acid salt for use in the treatment of alzheimer-type dementia |
| AU2018321335B2 (en) * | 2017-08-22 | 2025-08-14 | Biogen Ma Inc. | Pharmaceutical compositions containing anti-beta amyloid antibodies |
| JP6496095B1 (ja) | 2017-09-29 | 2019-04-03 | 中外製薬株式会社 | 血液凝固第ｖｉｉｉ因子（ｆｖｉｉｉ）補因子機能代替活性を有する多重特異性抗原結合分子および当該分子を有効成分として含有する薬学的製剤 |
| TW202600611A (zh) | 2017-11-01 | 2026-01-01 | 日商中外製藥股份有限公司 | 生物活性降低之抗體變異體與同功型 |
| US20240277839A1 (en) * | 2020-07-03 | 2024-08-22 | Csl Innovation Pty Ltd. | High concentration formulation and uses thereof |
| WO2023115112A1 (en) * | 2021-12-20 | 2023-06-29 | CSL Innovation Pty Ltd | Protein formulations and uses thereof |
| IL316264A (en) * | 2022-05-02 | 2024-12-01 | Regeneron Pharma | Antibody formulations against interleukin-4 receptor (IL-4R) |
| CN121263206A (zh) | 2023-05-31 | 2026-01-02 | 豪夫迈·罗氏有限公司 | 双特异性抗Aβ/TfR抗体的治疗性用途 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US5204244A (en) | 1987-10-27 | 1993-04-20 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5202238A (en) | 1987-10-27 | 1993-04-13 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5959177A (en) | 1989-10-27 | 1999-09-28 | The Scripps Research Institute | Transgenic plants expressing assembled secretory antibodies |
| CA2116774C (en) | 1991-09-19 | 2003-11-11 | Paul J. Carter | Expression in e. coli antibody fragments having at least a cysteine present as a free thiol. use for the production of bifunctional f(ab') 2 antibodies |
| US5789199A (en) | 1994-11-03 | 1998-08-04 | Genentech, Inc. | Process for bacterial production of polypeptides |
| US5840523A (en) | 1995-03-01 | 1998-11-24 | Genetech, Inc. | Methods and compositions for secretion of heterologous polypeptides |
| US6040498A (en) | 1998-08-11 | 2000-03-21 | North Caroline State University | Genetically engineered duckweed |
| PT1222292E (pt) | 1999-10-04 | 2005-11-30 | Medicago Inc | Metodo para regulacao da transcricao de genes exogenos na presenca de azoto |
| US7125978B1 (en) | 1999-10-04 | 2006-10-24 | Medicago Inc. | Promoter for regulating expression of foreign genes |
| CA2632828C (en) * | 2005-12-12 | 2012-07-10 | F. Hoffmann-La Roche Ag | Antibodies against amyloid beta with glycosylation in the variable region |
| CN101553504A (zh) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
-
2013
- 2013-03-05 AU AU2013229613A patent/AU2013229613B2/en active Active
- 2013-03-05 PL PL13707176T patent/PL2822587T3/pl unknown
- 2013-03-05 ES ES13707176.7T patent/ES2564281T3/es active Active
- 2013-03-05 SG SG11201404481RA patent/SG11201404481RA/en unknown
- 2013-03-05 MX MX2014009662A patent/MX351148B/es active IP Right Grant
- 2013-03-05 WO PCT/EP2013/054313 patent/WO2013131866A1/en not_active Ceased
- 2013-03-05 HR HRP20160434TT patent/HRP20160434T1/hr unknown
- 2013-03-05 EP EP13707176.7A patent/EP2822587B1/en active Active
- 2013-03-05 CN CN201380012493.4A patent/CN104159613B/zh active Active
- 2013-03-05 NZ NZ626955A patent/NZ626955A/en unknown
- 2013-03-05 HU HUE13707176A patent/HUE028440T2/en unknown
- 2013-03-05 US US14/381,849 patent/US20150030589A1/en not_active Abandoned
- 2013-03-05 KR KR1020147025086A patent/KR101666289B1/ko active Active
- 2013-03-05 DK DK13707176.7T patent/DK2822587T3/en active
- 2013-03-05 RS RS20160187A patent/RS54644B1/sr unknown
- 2013-03-05 JP JP2014560323A patent/JP5859148B2/ja active Active
- 2013-03-05 SI SI201330150T patent/SI2822587T1/sl unknown
- 2013-03-05 BR BR112014019667-2A patent/BR112014019667B1/pt active IP Right Grant
- 2013-03-05 RU RU2014140137A patent/RU2014140137A/ru not_active Application Discontinuation
- 2013-03-05 CA CA2860543A patent/CA2860543C/en active Active
- 2013-03-05 MY MYPI2014002221A patent/MY166045A/en unknown
- 2013-03-07 AR ARP130100743A patent/AR090272A1/es not_active Application Discontinuation
-
2014
- 2014-07-11 ZA ZA2014/05103A patent/ZA201405103B/en unknown
- 2014-08-14 IL IL234120A patent/IL234120B/en active IP Right Grant
-
2016
- 2016-04-12 CY CY20161100295T patent/CY1117363T1/el unknown
-
2021
- 2021-06-25 AR ARP210101758A patent/AR122746A2/es unknown
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