SI3021833T1 - Postopki in formulacije, ki dopuščajo modulacijo imunskih odzivov, povezanih z dajanjem biofarmacevtskega zdravila - Google Patents
Postopki in formulacije, ki dopuščajo modulacijo imunskih odzivov, povezanih z dajanjem biofarmacevtskega zdravilaInfo
- Publication number
- SI3021833T1 SI3021833T1 SI201430872T SI201430872T SI3021833T1 SI 3021833 T1 SI3021833 T1 SI 3021833T1 SI 201430872 T SI201430872 T SI 201430872T SI 201430872 T SI201430872 T SI 201430872T SI 3021833 T1 SI3021833 T1 SI 3021833T1
- Authority
- SI
- Slovenia
- Prior art keywords
- formulations
- administration
- modulation
- allow
- methods
- Prior art date
Links
- 229960000074 biopharmaceutical Drugs 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- 239000003814 drug Substances 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 230000028993 immune response Effects 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
Classifications
-
- 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
- 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
- A61K39/395—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)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (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)
Applications Claiming Priority (3)
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 |
EP14744505.0A EP3021833B2 (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 |
---|---|
SI3021833T1 true SI3021833T1 (sl) | 2018-10-30 |
SI3021833T2 SI3021833T2 (sl) | 2022-08-31 |
Family
ID=48794008
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SI201430872T SI3021833T2 (sl) | 2013-07-19 | 2014-07-21 | Postopki in formulacije, ki dopuščajo modulacijo imunskih odzivov, povezanih z dajanjem biofarmacevtskega zdravila |
Country Status (12)
Country | Link |
---|---|
US (1) | US20160151484A1 (sl) |
EP (1) | EP3021833B2 (sl) |
JP (2) | JP2016525110A (sl) |
CN (1) | CN105377237B (sl) |
AU (1) | AU2014291970B2 (sl) |
BR (1) | BR112016000563A2 (sl) |
CA (1) | CA2914776C (sl) |
ES (1) | ES2688726T5 (sl) |
MX (2) | MX2016000405A (sl) |
RU (1) | RU2662558C2 (sl) |
SI (1) | SI3021833T2 (sl) |
WO (1) | WO2015007912A1 (sl) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2702077A2 (en) | 2011-04-27 | 2014-03-05 | AbbVie Inc. | Methods for controlling the galactosylation profile of recombinantly-expressed proteins |
US9150645B2 (en) | 2012-04-20 | 2015-10-06 | Abbvie, Inc. | Cell culture methods to reduce acidic species |
US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
WO2013158273A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Methods to modulate c-terminal 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 |
CA2905010A1 (en) | 2013-03-12 | 2014-09-18 | Abbvie Inc. | Human antibodies that bind human tnf-alpha and methods of preparing the same |
WO2014151878A2 (en) | 2013-03-14 | 2014-09-25 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides |
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 |
EP3052640A2 (en) | 2013-10-04 | 2016-08-10 | 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 |
WO2015073884A2 (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 |
US8496930B2 (en) * | 2003-10-01 | 2013-07-30 | Kyowa Hakko Kirin Co., Ltd | Method of stabilizing antibody and stabilized solution-type antibody preparation |
GB0503337D0 (en) * | 2005-02-17 | 2005-03-23 | Glaxosmithkline Biolog Sa | Compositions |
NZ592644A (en) * | 2008-11-28 | 2013-09-27 | Abbott Lab | Stable antibody compositions and methods for stabilizing same |
KR20120038406A (ko) * | 2009-05-04 | 2012-04-23 | 애보트 바이오테크놀로지 리미티드 | 인간 항?TNF?α 항체의 안정한 고 단백질 농도 제형 |
TWI606840B (zh) | 2010-11-11 | 2017-12-01 | 艾伯維生物技術有限責任公司 | 具有增進高濃度之抗-TNFα抗體之液體調配物 |
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 RU RU2016105462A patent/RU2662558C2/ru active
- 2014-07-21 US US14/905,689 patent/US20160151484A1/en not_active Abandoned
- 2014-07-21 JP JP2016526663A patent/JP2016525110A/ja active Pending
- 2014-07-21 WO PCT/EP2014/065612 patent/WO2015007912A1/en active Application Filing
- 2014-07-21 CN CN201480040059.1A patent/CN105377237B/zh active Active
- 2014-07-21 CA CA2914776A patent/CA2914776C/en not_active Expired - Fee Related
- 2014-07-21 MX MX2016000405A patent/MX2016000405A/es unknown
- 2014-07-21 ES ES14744505T patent/ES2688726T5/es active Active
- 2014-07-21 BR BR112016000563A patent/BR112016000563A2/pt active Search and Examination
- 2014-07-21 SI SI201430872T patent/SI3021833T2/sl unknown
- 2014-07-21 EP EP14744505.0A patent/EP3021833B2/en active Active
- 2014-07-21 AU AU2014291970A patent/AU2014291970B2/en active Active
-
2016
- 2016-01-12 MX MX2020005247A patent/MX2020005247A/es unknown
-
2017
- 2017-08-24 JP JP2017160728A patent/JP6797767B2/ja active Active
Also Published As
Publication number | Publication date |
---|---|
MX2020005247A (es) | 2020-08-24 |
EP3021833A1 (en) | 2016-05-25 |
BR112016000563A2 (pt) | 2017-09-05 |
RU2662558C2 (ru) | 2018-07-26 |
CA2914776A1 (en) | 2015-01-22 |
ES2688726T3 (es) | 2018-11-06 |
EP3021833B2 (en) | 2022-03-30 |
ES2688726T5 (es) | 2022-06-27 |
WO2015007912A1 (en) | 2015-01-22 |
EP3021833B1 (en) | 2018-06-27 |
US20160151484A1 (en) | 2016-06-02 |
JP6797767B2 (ja) | 2020-12-09 |
CN105377237B (zh) | 2019-04-19 |
MX2016000405A (es) | 2016-09-09 |
CN105377237A (zh) | 2016-03-02 |
JP2018012716A (ja) | 2018-01-25 |
JP2016525110A (ja) | 2016-08-22 |
AU2014291970A1 (en) | 2016-01-28 |
SI3021833T2 (sl) | 2022-08-31 |
RU2016105462A (ru) | 2017-08-24 |
CA2914776C (en) | 2018-08-07 |
AU2014291970B2 (en) | 2017-09-28 |
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