MX2017003121A - Formulaciones de anticuerpos. - Google Patents
Formulaciones de anticuerpos.Info
- Publication number
- MX2017003121A MX2017003121A MX2017003121A MX2017003121A MX2017003121A MX 2017003121 A MX2017003121 A MX 2017003121A MX 2017003121 A MX2017003121 A MX 2017003121A MX 2017003121 A MX2017003121 A MX 2017003121A MX 2017003121 A MX2017003121 A MX 2017003121A
- Authority
- MX
- Mexico
- Prior art keywords
- formulations
- antibody formulations
- methods
- provides
- trehalose
- Prior art date
Links
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
- 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
- A61K47/16—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
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- 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
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- 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
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- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
-
- 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
- C07K2317/90—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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Urology & Nephrology (AREA)
- Pulmonology (AREA)
- Rheumatology (AREA)
- Analytical Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Endocrinology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
Abstract
La invención proporciona formulaciones farmacéuticas acuosas estables que comprenden un anticuerpo terapéutico, trehalosa, un amortiguador, un tensioactivo opcional y tener un pH en el intervalo de alrededor de 5,5 a alrededor de 7,0. La invención también proporciona métodos para hacer tales formulaciones y métodos para utilizar tales formulaciones.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462050739P | 2014-09-15 | 2014-09-15 | |
PCT/US2015/050278 WO2016044334A1 (en) | 2014-09-15 | 2015-09-15 | Antibody formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2017003121A true MX2017003121A (es) | 2017-08-02 |
Family
ID=54238581
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2017003121A MX2017003121A (es) | 2014-09-15 | 2015-09-15 | Formulaciones de anticuerpos. |
Country Status (15)
Country | Link |
---|---|
US (2) | US20160137727A1 (es) |
EP (1) | EP3193932B1 (es) |
JP (3) | JP7072384B2 (es) |
KR (1) | KR20170057339A (es) |
CN (1) | CN106794247B (es) |
AU (1) | AU2015318001B2 (es) |
BR (1) | BR112017004393A2 (es) |
CA (1) | CA2959545A1 (es) |
ES (1) | ES2949173T3 (es) |
IL (1) | IL250731B (es) |
MX (1) | MX2017003121A (es) |
RU (1) | RU2704611C2 (es) |
SG (1) | SG11201701821QA (es) |
WO (1) | WO2016044334A1 (es) |
ZA (1) | ZA201701461B (es) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102127085B1 (ko) | 2013-03-13 | 2020-06-26 | 제넨테크, 인크. | 항체 제제 |
EP3193932B1 (en) | 2014-09-15 | 2023-04-26 | F. Hoffmann-La Roche AG | Antibody formulations |
CN107206080B (zh) | 2015-01-28 | 2022-07-08 | 辉瑞公司 | 稳定的水性抗血管内皮细胞生长因子(vegf)抗体制剂 |
MX2019007564A (es) | 2016-12-23 | 2019-09-06 | Serum Institute Of India Pvt Ltd | Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion corriente abajo y formulaciones de anticuerpos estables obtenidas a partir de los mismos. |
EP3570884B1 (en) | 2017-01-17 | 2020-09-30 | Genentech, Inc. | Subcutaneous her2 antibody formulations |
PE20200738A1 (es) * | 2017-08-08 | 2020-07-23 | Hoffmann La Roche | Tratamiento con obinutuzumab nuevo subgrupo de pacientes con nuevo linfoma de celulas b grandes difusas (dlbcl) |
CR20210435A (es) | 2019-02-18 | 2021-09-20 | Lilly Co Eli | Formulación de anticuerpos terapéuticos |
TW202126284A (zh) * | 2019-09-30 | 2021-07-16 | 美商百歐維拉提夫治療公司 | 慢病毒載體配製物 |
CN112675126A (zh) * | 2019-10-18 | 2021-04-20 | 百奥泰生物制药股份有限公司 | 抗cd20抗体制剂及其应用 |
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-
2015
- 2015-09-15 EP EP15772124.2A patent/EP3193932B1/en active Active
- 2015-09-15 MX MX2017003121A patent/MX2017003121A/es unknown
- 2015-09-15 KR KR1020177010007A patent/KR20170057339A/ko active IP Right Grant
- 2015-09-15 JP JP2017514450A patent/JP7072384B2/ja active Active
- 2015-09-15 AU AU2015318001A patent/AU2015318001B2/en not_active Ceased
- 2015-09-15 US US14/855,325 patent/US20160137727A1/en not_active Abandoned
- 2015-09-15 WO PCT/US2015/050278 patent/WO2016044334A1/en active Application Filing
- 2015-09-15 BR BR112017004393A patent/BR112017004393A2/pt not_active Application Discontinuation
- 2015-09-15 CA CA2959545A patent/CA2959545A1/en not_active Abandoned
- 2015-09-15 ES ES15772124T patent/ES2949173T3/es active Active
- 2015-09-15 CN CN201580054042.6A patent/CN106794247B/zh active Active
- 2015-09-15 SG SG11201701821QA patent/SG11201701821QA/en unknown
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- 2017-02-27 ZA ZA2017/01461A patent/ZA201701461B/en unknown
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Also Published As
Publication number | Publication date |
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US11370833B2 (en) | 2022-06-28 |
WO2016044334A1 (en) | 2016-03-24 |
CN106794247A (zh) | 2017-05-31 |
BR112017004393A2 (pt) | 2018-02-27 |
ES2949173T3 (es) | 2023-09-26 |
CN106794247B (zh) | 2022-12-02 |
JP7072384B2 (ja) | 2022-05-20 |
ZA201701461B (en) | 2022-07-27 |
EP3193932A1 (en) | 2017-07-26 |
AU2015318001B2 (en) | 2021-03-25 |
JP2017528480A (ja) | 2017-09-28 |
KR20170057339A (ko) | 2017-05-24 |
JP2022084590A (ja) | 2022-06-07 |
EP3193932B1 (en) | 2023-04-26 |
IL250731A0 (en) | 2017-04-30 |
IL250731B (en) | 2021-03-25 |
US20190161541A1 (en) | 2019-05-30 |
CA2959545A1 (en) | 2016-03-24 |
SG11201701821QA (en) | 2017-04-27 |
RU2017112703A3 (es) | 2019-04-23 |
RU2017112703A (ru) | 2018-10-17 |
RU2704611C2 (ru) | 2019-10-30 |
US20160137727A1 (en) | 2016-05-19 |
JP2020189842A (ja) | 2020-11-26 |
AU2015318001A1 (en) | 2017-03-23 |
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