MX2016000405A - Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico. - Google Patents
Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico.Info
- Publication number
- MX2016000405A MX2016000405A MX2016000405A MX2016000405A MX2016000405A MX 2016000405 A MX2016000405 A MX 2016000405A MX 2016000405 A MX2016000405 A MX 2016000405A MX 2016000405 A MX2016000405 A MX 2016000405A MX 2016000405 A MX2016000405 A MX 2016000405A
- Authority
- MX
- Mexico
- Prior art keywords
- methods
- administration
- modulation
- immune responses
- responses related
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 5
- 229960000074 biopharmaceutical Drugs 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 abstract 6
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 abstract 4
- 150000003839 salts Chemical class 0.000 abstract 4
- 229960000250 adipic acid Drugs 0.000 abstract 2
- 235000011037 adipic acid Nutrition 0.000 abstract 2
- 230000028993 immune response Effects 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 230000005847 immunogenicity Effects 0.000 abstract 1
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
-
- 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
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- C07K16/241—Tumor Necrosis 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising 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
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55511—Organic adjuvants
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (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)
Abstract
La presente invención se refiere a métodos de preparación de una formulación farmacéutica que comprende un fármaco biofarmacéutico, dichos métodos permite la modulación de las respuestas inmunitarias relacionadas con la administración de la misma. La formulación comprende un regulador de pH que comprende ácido hexanodioico o por lo menos una sal del mismo, y/o ácido cítrico o por lo menos una sal del mismo. La presente invención se refiere además a un método de uso de ácido hexanodioico o por lo menos una sal del mismo, y/o ácido cítrico o por lo menos una sal del mismo, para modular la inmunogenicidad de una formulación farmacéutica, a una formulación farmacéutica como tal, y a métodos de modulación o determinación de respuestas inmunitarias relacionadas con la administración de una formulación farmacéutica (Figura 4).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13177259 | 2013-07-19 | ||
| PCT/EP2014/065612 WO2015007912A1 (en) | 2013-07-19 | 2014-07-21 | Methods and formulations which allow the modulation of immune responses related to the administration of a biopharmaceutical drug |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2016000405A true MX2016000405A (es) | 2016-09-09 |
| MX380569B MX380569B (es) | 2025-03-12 |
Family
ID=48794008
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2016000405A MX380569B (es) | 2013-07-19 | 2014-07-21 | Métodos y formulaciones que permiten la modulación de respuestas inmunitarias relacionadas con la administración de un fármaco biofarmacéutico. |
| MX2020005247A MX2020005247A (es) | 2013-07-19 | 2016-01-12 | Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico. |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2020005247A MX2020005247A (es) | 2013-07-19 | 2016-01-12 | Metodos y formulaciones que permiten la modulacion de respuestas inmunitarias relacionadas con la administracion de un farmaco biofarmaceutico. |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20160151484A1 (es) |
| EP (1) | EP3021833B2 (es) |
| JP (2) | JP2016525110A (es) |
| CN (1) | CN105377237B (es) |
| AU (1) | AU2014291970B2 (es) |
| BR (1) | BR112016000563A2 (es) |
| CA (1) | CA2914776C (es) |
| ES (1) | ES2688726T5 (es) |
| MX (2) | MX380569B (es) |
| RU (1) | RU2662558C2 (es) |
| SI (1) | SI3021833T2 (es) |
| WO (1) | WO2015007912A1 (es) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9062106B2 (en) | 2011-04-27 | 2015-06-23 | Abbvie Inc. | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
| US9334319B2 (en) | 2012-04-20 | 2016-05-10 | Abbvie Inc. | Low acidic species compositions |
| US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
| US9181572B2 (en) | 2012-04-20 | 2015-11-10 | Abbvie, Inc. | Methods to modulate lysine variant distribution |
| US9249182B2 (en) | 2012-05-24 | 2016-02-02 | Abbvie, Inc. | Purification of antibodies using hydrophobic interaction chromatography |
| US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
| SG11201507230PA (en) | 2013-03-12 | 2015-10-29 | Abbvie Inc | Human antibodies that bind human tnf-alpha and methods of preparing the same |
| US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
| WO2014151878A2 (en) | 2013-03-14 | 2014-09-25 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides |
| WO2015051293A2 (en) | 2013-10-04 | 2015-04-09 | Abbvie, Inc. | Use of metal ions for modulation of protein glycosylation profiles of recombinant proteins |
| US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
| US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
| US20150139988A1 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| CN100522998C (zh) * | 2003-10-01 | 2009-08-05 | 协和发酵麒麟株式会社 | 抗体的稳定化方法和被稳定的溶液状抗体制剂 |
| GB0503337D0 (en) * | 2005-02-17 | 2005-03-23 | Glaxosmithkline Biolog Sa | Compositions |
| KR20110096553A (ko) * | 2008-11-28 | 2011-08-30 | 아보트 러보러터리즈 | 안정한 항체 조성물 및 이의 안정화 방법 |
| NZ613809A (en) * | 2009-05-04 | 2015-02-27 | Abbvie Biotechnology Ltd | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| PL2637690T3 (pl) | 2010-11-11 | 2017-03-31 | Abbvie Biotechnology Ltd | Płynne formulacje zawierające przeciwciało anty-tnf alfa o wysokim stężeniu |
| EP2471554A1 (en) * | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| GB201112429D0 (en) * | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| RU2683020C2 (ru) * | 2014-11-11 | 2019-03-26 | Петр Иванович Никитин | Субстанция и способ для модуляции активности агента в организме |
-
2014
- 2014-07-21 EP EP14744505.0A patent/EP3021833B2/en active Active
- 2014-07-21 CN CN201480040059.1A patent/CN105377237B/zh active Active
- 2014-07-21 RU RU2016105462A patent/RU2662558C2/ru active
- 2014-07-21 US US14/905,689 patent/US20160151484A1/en not_active Abandoned
- 2014-07-21 BR BR112016000563A patent/BR112016000563A2/pt not_active Application Discontinuation
- 2014-07-21 MX MX2016000405A patent/MX380569B/es unknown
- 2014-07-21 JP JP2016526663A patent/JP2016525110A/ja active Pending
- 2014-07-21 SI SI201430872T patent/SI3021833T2/sl unknown
- 2014-07-21 WO PCT/EP2014/065612 patent/WO2015007912A1/en not_active Ceased
- 2014-07-21 AU AU2014291970A patent/AU2014291970B2/en not_active Ceased
- 2014-07-21 ES ES14744505T patent/ES2688726T5/es active Active
- 2014-07-21 CA CA2914776A patent/CA2914776C/en not_active Expired - Fee Related
-
2016
- 2016-01-12 MX MX2020005247A patent/MX2020005247A/es unknown
-
2017
- 2017-08-24 JP JP2017160728A patent/JP6797767B2/ja not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015007912A1 (en) | 2015-01-22 |
| EP3021833A1 (en) | 2016-05-25 |
| BR112016000563A2 (pt) | 2017-09-05 |
| JP6797767B2 (ja) | 2020-12-09 |
| SI3021833T1 (sl) | 2018-10-30 |
| CN105377237A (zh) | 2016-03-02 |
| ES2688726T3 (es) | 2018-11-06 |
| AU2014291970A1 (en) | 2016-01-28 |
| JP2016525110A (ja) | 2016-08-22 |
| AU2014291970B2 (en) | 2017-09-28 |
| ES2688726T5 (es) | 2022-06-27 |
| SI3021833T2 (sl) | 2022-08-31 |
| MX380569B (es) | 2025-03-12 |
| EP3021833B2 (en) | 2022-03-30 |
| US20160151484A1 (en) | 2016-06-02 |
| CA2914776A1 (en) | 2015-01-22 |
| MX2020005247A (es) | 2020-08-24 |
| JP2018012716A (ja) | 2018-01-25 |
| CN105377237B (zh) | 2019-04-19 |
| EP3021833B1 (en) | 2018-06-27 |
| RU2016105462A (ru) | 2017-08-24 |
| CA2914776C (en) | 2018-08-07 |
| RU2662558C2 (ru) | 2018-07-26 |
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