AR090272A1 - FORMULACION DE ANTICUERPOS Ab - Google Patents
FORMULACION DE ANTICUERPOS AbInfo
- Publication number
- AR090272A1 AR090272A1 ARP130100743A ARP130100743A AR090272A1 AR 090272 A1 AR090272 A1 AR 090272A1 AR P130100743 A ARP130100743 A AR P130100743A AR P130100743 A ARP130100743 A AR P130100743A AR 090272 A1 AR090272 A1 AR 090272A1
- Authority
- AR
- Argentina
- Prior art keywords
- antibody
- approx
- pharmaceutical formulation
- antibodies
- seq
- Prior art date
Links
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
- 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
- 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
- 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
-
- 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
-
- 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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Endocrinology (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
Reivindicación 1: Una formulación farmacéutica líquida estable de anticuerpo que contiene: aprox. de 50 mg/ml a 200 mg/ml de un anticuerpo Ab, aprox. del 0,01 % al 0,1% de un poloxámero, con preferencia del poloxámero 188, aprox. de 5 mM a 50 mM de un tampón, aprox. de 100 mM a 300 mM de un estabilizante, de un pH comprendido aprox. entre 4,5 y 7,0. Reivindicación 7: La formulación farmacéutica de las reivindicaciones de 1 a 6, cuyo estabilizante se elige entre azúcares y aminoácidos. Reivindicación 8: La formulación farmacéutica de la reivindicación 7, cuyo estabilizante se elige entre trehalosa y arginina. Reivindicación 12: La formulación farmacéutica de las reivindicaciones de 1 a 10, en la que el anticuerpo Ab es un anticuerpo monoclonal que tiene una cadena larga y una cadena corta. Reivindicación 18: La formulación farmacéutica de las reivindicaciones de 11 a 16, en la que el anticuerpo monoclonal Ab es una mezcla de anticuerpos Ab monoglicosilados y anticuerpos Ab biglicosilados, dicho anticuerpo monoglicosilado contiene una asparagina glicosilada (Asn) en la posición 52 de la Seq. Id. Nº 2 en el dominio VH de un sitio de unión de anticuerpo y en la que el anticuerpo biglicosilado contiene una asparagina glicosilada (Asn) en la posición 52 de la Seq. Id. Nº 2 en el dominio VH de los dos sitios de unión del anticuerpo y dicha mezcla contiene menos del 5% de un anticuerpo no glicosilado en la posición 52 de la Seq. Id. Nº 2 en el dominio VH.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12158602 | 2012-03-08 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR090272A1 true AR090272A1 (es) | 2014-10-29 |
Family
ID=47780075
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP130100743A AR090272A1 (es) | 2012-03-08 | 2013-03-07 | FORMULACION DE ANTICUERPOS Ab |
| ARP210101758A AR122746A2 (es) | 2012-03-08 | 2021-06-25 | Una formulación farmacéutica líquida estable de anticuerpo |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP210101758A AR122746A2 (es) | 2012-03-08 | 2021-06-25 | Una formulación farmacéutica líquida estable de anticuerpo |
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 (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006106905A1 (ja) | 2005-03-31 | 2006-10-12 | Chugai Seiyaku Kabushiki Kaisha | 会合制御によるポリペプチド製造方法 |
| 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 |
| DK2006381T3 (en) | 2006-03-31 | 2016-02-22 | Chugai Pharmaceutical Co Ltd | PROCEDURE FOR REGULATING ANTIBODIES BLOOD PHARMACOKINETICS |
| DK2202245T3 (en) | 2007-09-26 | 2016-11-21 | Chugai Pharmaceutical Co Ltd | A method of modifying an antibody isoelectric point VIA amino acid substitution in CDR |
| 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). |
| PT2624865T (pt) * | 2010-10-06 | 2018-11-05 | Regeneron Pharma | Formulações estabilizadas que contêm anticorpos anti-recetor de interleucina-4 (il-4r) |
| PH12013500974A1 (en) | 2010-11-17 | 2013-07-08 | Chugai Pharmaceutical Co Ltd | Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii |
| PL2668212T3 (pl) | 2011-01-28 | 2018-08-31 | Sanofi Biotechnology | Ludzkie przeciwciała przeciwko pcsk9 do zastosowania w sposobach leczenia konkretnych grup osobników |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| SG10201803449VA (en) | 2013-09-27 | 2018-05-30 | Chugai Pharmaceutical Co Ltd | Method for producing polypeptide heteromultimer |
| 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 |
| 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 |
| DK3313879T3 (da) | 2015-06-24 | 2022-03-14 | Hoffmann La Roche | Anti-transferrinreceptor-antistoffer med tilpasset affinitet |
| AU2016308111A1 (en) | 2015-08-18 | 2018-03-01 | Regeneron Pharmaceuticals, Inc. | Anti-PCSK9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis |
| EP3356406A1 (en) | 2015-10-02 | 2018-08-08 | H. Hoffnabb-La Roche Ag | Bispecific anti-human cd20/human transferrin receptor antibodies and methods of use |
| 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 |
| US20200270363A1 (en) | 2015-12-25 | 2020-08-27 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| WO2017115773A1 (ja) | 2015-12-28 | 2017-07-06 | 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 |
| UA126900C2 (uk) | 2016-04-28 | 2023-02-22 | Чугаі Сейяку Кабусікі Кайся | Антитіловмісний препарат |
| 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 |
| WO2018221244A1 (ja) * | 2017-05-30 | 2018-12-06 | 森永乳業株式会社 | 脳機能改善用組成物 |
| WO2019040612A1 (en) | 2017-08-22 | 2019-02-28 | Biogen Ma Inc. | PHARMACEUTICAL COMPOSITIONS CONTAINING ANTI-BETA-AMYLOID ANTIBODIES |
| IL273592B2 (en) | 2017-09-29 | 2025-11-01 | Chugai Pharmaceutical Co Ltd | Multispecific antigen-binding molecule having blood coagulation factor viii (fviii) cofactor function-substituting activity, and pharmaceutical formulation containing said molecule as active ingredient |
| JPWO2019088143A1 (ja) | 2017-11-01 | 2020-11-12 | 中外製薬株式会社 | 生物活性が低下した抗体バリアントおよびアイソフォーム |
| CN116322764A (zh) * | 2020-07-03 | 2023-06-23 | 杰特创新股份有限公司 | 因子xii抗原结合蛋白的高浓度制剂 |
| US20250042984A1 (en) * | 2021-12-20 | 2025-02-06 | CSL Innovation Pty Ltd | Protein formulations and uses thereof |
| WO2023215267A1 (en) * | 2022-05-02 | 2023-11-09 | Regeneron Pharmaceuticals, Inc. | Anti-interleukin-4 receptor (il-4r) antibody formulations |
| WO2024246085A1 (en) | 2023-05-31 | 2024-12-05 | F. Hoffmann-La Roche Ag | Therapeutic use of bispecific anti-abeta/tfr antibodies |
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 |
| WO1993006217A1 (en) | 1991-09-19 | 1993-04-01 | Genentech, Inc. | EXPRESSION IN E. COLI OF 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 |
| US7125978B1 (en) | 1999-10-04 | 2006-10-24 | Medicago Inc. | Promoter for regulating expression of foreign genes |
| KR100797667B1 (ko) | 1999-10-04 | 2008-01-23 | 메디카고 인코포레이티드 | 외래 유전자의 전사를 조절하는 방법 |
| CA2632828C (en) * | 2005-12-12 | 2012-07-10 | F. Hoffmann-La Roche Ag | Antibodies against amyloid beta with glycosylation in the variable region |
| CA2671968A1 (en) * | 2006-12-11 | 2008-06-19 | F. Hoffmann-La Roche Ag | Abeta antibody parenteral formulation |
-
2013
- 2013-03-05 RS RS20160187A patent/RS54644B1/sr unknown
- 2013-03-05 JP JP2014560323A patent/JP5859148B2/ja active Active
- 2013-03-05 ES ES13707176.7T patent/ES2564281T3/es active Active
- 2013-03-05 HU HUE13707176A patent/HUE028440T2/en unknown
- 2013-03-05 MY MYPI2014002221A patent/MY166045A/en unknown
- 2013-03-05 KR KR1020147025086A patent/KR101666289B1/ko active Active
- 2013-03-05 CA CA2860543A patent/CA2860543C/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 BR BR112014019667-2A patent/BR112014019667B1/pt active IP Right Grant
- 2013-03-05 US US14/381,849 patent/US20150030589A1/en not_active Abandoned
- 2013-03-05 AU AU2013229613A patent/AU2013229613B2/en active Active
- 2013-03-05 DK DK13707176.7T patent/DK2822587T3/en active
- 2013-03-05 EP EP13707176.7A patent/EP2822587B1/en active Active
- 2013-03-05 HR HRP20160434TT patent/HRP20160434T1/hr unknown
- 2013-03-05 PL PL13707176T patent/PL2822587T3/pl unknown
- 2013-03-05 RU RU2014140137A patent/RU2014140137A/ru not_active Application Discontinuation
- 2013-03-05 SG SG11201404481RA patent/SG11201404481RA/en unknown
- 2013-03-05 SI SI201330150T patent/SI2822587T1/sl 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
- 2013-03-07 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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