BR112012021873A2 - composições de matéria, artigo de manufatura, método de preparação de uma formulação contendo proteína estabilizada, método para aumentar a estabilidade de uma proteína em solução aquosa e método de prevenção ou redução da agregação de uma proteína em solução aquosa - Google Patents
composições de matéria, artigo de manufatura, método de preparação de uma formulação contendo proteína estabilizada, método para aumentar a estabilidade de uma proteína em solução aquosa e método de prevenção ou redução da agregação de uma proteína em solução aquosaInfo
- Publication number
- BR112012021873A2 BR112012021873A2 BR112012021873A BR112012021873A BR112012021873A2 BR 112012021873 A2 BR112012021873 A2 BR 112012021873A2 BR 112012021873 A BR112012021873 A BR 112012021873A BR 112012021873 A BR112012021873 A BR 112012021873A BR 112012021873 A2 BR112012021873 A2 BR 112012021873A2
- Authority
- BR
- Brazil
- Prior art keywords
- protein
- aqueous solution
- aggregation
- article
- preparing
- Prior art date
Links
- 238000000034 method Methods 0.000 title 3
- 102000004169 proteins and genes Human genes 0.000 title 3
- 108090000623 proteins and genes Proteins 0.000 title 3
- 239000007864 aqueous solution Substances 0.000 title 2
- 239000000203 mixture Substances 0.000 title 2
- 238000004220 aggregation Methods 0.000 title 1
- 230000002776 aggregation Effects 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
-
- 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
-
- 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
- A61K47/08—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
- A61K47/26—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
- C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
- C07K16/4291—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
-
- 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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Pathology (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)
- Compositions Of Macromolecular Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US31632610P | 2010-03-22 | 2010-03-22 | |
| US61/316,326 | 2010-03-22 | ||
| PCT/US2011/029206 WO2011119487A2 (en) | 2010-03-22 | 2011-03-21 | Compositions and methods useful for stabilizing protein-containing formulations |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR112012021873A2 true BR112012021873A2 (pt) | 2016-05-24 |
| BR112012021873B1 BR112012021873B1 (pt) | 2021-05-11 |
| BR112012021873B8 BR112012021873B8 (pt) | 2021-09-14 |
Family
ID=43977896
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112012021873A BR112012021873B8 (pt) | 2010-03-22 | 2011-03-21 | composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato |
Country Status (16)
| Country | Link |
|---|---|
| US (3) | US9662395B2 (pt) |
| EP (2) | EP2550018B1 (pt) |
| JP (3) | JP5937059B2 (pt) |
| KR (3) | KR20180000342A (pt) |
| CN (3) | CN104998269B (pt) |
| BR (1) | BR112012021873B8 (pt) |
| CA (2) | CA2792125C (pt) |
| ES (1) | ES2722201T3 (pt) |
| HK (1) | HK1216842A1 (pt) |
| HR (1) | HRP20190751T1 (pt) |
| MX (1) | MX354867B (pt) |
| PL (1) | PL2550018T3 (pt) |
| RU (1) | RU2584232C2 (pt) |
| SI (1) | SI2550018T1 (pt) |
| TR (1) | TR201905081T4 (pt) |
| WO (1) | WO2011119487A2 (pt) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112012021873B8 (pt) | 2010-03-22 | 2021-09-14 | Genentech Inc | composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato |
| EP4218937A3 (en) * | 2011-10-31 | 2023-10-25 | F. Hoffmann-La Roche AG | Anti-il13 antibody formulations |
| EP3071237A1 (en) * | 2013-11-21 | 2016-09-28 | Genmab A/S | Antibody-drug conjugate lyophilised formulation |
| MX2016013559A (es) * | 2014-04-16 | 2017-04-27 | Biocon Ltd | Formulaciones de proteina estables que comprenden un exceso molar de sorbitol. |
| IS3008B (is) | 2014-05-14 | 2018-12-15 | Calor ehf | Stöðgandi lausnir fyrir prótín og peptíð |
| ES2600488T3 (es) | 2014-05-23 | 2017-02-09 | Ares Trading S.A. | Composición farmacéutica líquida |
| ES2572919T3 (es) | 2014-05-23 | 2016-06-03 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3053572A1 (en) * | 2015-02-06 | 2016-08-10 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2017121867A1 (en) * | 2016-01-13 | 2017-07-20 | Genmab A/S | Formulation for antibody and drug conjugate thereof |
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| CN106771148B (zh) * | 2016-12-28 | 2018-03-06 | 广州华弘生物科技有限公司 | 一种免疫球蛋白m检测试剂盒及检测方法 |
| US20200408688A1 (en) * | 2018-03-23 | 2020-12-31 | Konica Minolta, Inc. | Labeled antibody dispersion liquid and kit for spfs |
| MX2021012032A (es) * | 2019-04-01 | 2021-11-03 | Genentech Inc | Composiciones y metodos para estabilizar formulaciones que contienen proteinas. |
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| CN111964942A (zh) * | 2020-08-28 | 2020-11-20 | 湖南海尚仪器设备有限公司 | 基于工业环境污染物检测的采样方法 |
| AU2021379990A1 (en) * | 2020-11-16 | 2023-06-29 | W. L. Gore & Associates, Inc. | Formulations, methods, and pre-filled multi-dose injection devices without cloud point |
| CN112816684A (zh) * | 2021-01-07 | 2021-05-18 | 武汉华美生物工程有限公司 | 血清淀粉样蛋白a的校准品稀释液、其制备方法及其应用 |
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| BR112012021873B8 (pt) | 2010-03-22 | 2021-09-14 | Genentech Inc | composição de matéria, artigo de manufatura, métodos para preparar uma composição, para aumentar a estabilidade de uma proteína em solução aquosa livre de polissorbato e para prevenir ou reduzir a agregação de uma proteína em solução aquosa livre de polissorbato |
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2011
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2017
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2018
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