BR112015008186A2 - formulação de um anticorpo estável e de baixa viscosidade - Google Patents
formulação de um anticorpo estável e de baixa viscosidadeInfo
- Publication number
- BR112015008186A2 BR112015008186A2 BR112015008186A BR112015008186A BR112015008186A2 BR 112015008186 A2 BR112015008186 A2 BR 112015008186A2 BR 112015008186 A BR112015008186 A BR 112015008186A BR 112015008186 A BR112015008186 A BR 112015008186A BR 112015008186 A2 BR112015008186 A2 BR 112015008186A2
- Authority
- BR
- Brazil
- Prior art keywords
- formulation
- antibody
- stable
- low viscosity
- viscosity antibody
- Prior art date
Links
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]
- C07K16/248—IL-6
-
- 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
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61P19/00—Drugs for skeletal disorders
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- 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]
Abstract
resumo patente de invenção: "formulação de um anticorpo estável e de baixa viscosidade". a presente invenção refere-se a uma formulação de um anticorpo estável e de baixa viscosidade, em que a formulação compreende uma elevada concentração de um anticorpo anti-il6. em algumas modalidades, a invenção refere-se a uma formulação de anticorpo estável e de baixa viscosidade, que compreende cerca de 50 mg/ml a cerca de 400 mg/ml de um anticorpo anti-il6, e arginina, em que a formulação do anticorpo está em uma solução aquosa e tem uma viscosidade de menos de 20 cp a 23 oc. são também fornecidos métodos para preparar e métodos para usar essas formulações do anticorpo.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261718379P | 2012-10-25 | 2012-10-25 | |
| PCT/US2013/066313 WO2014066468A1 (en) | 2012-10-25 | 2013-10-23 | Stable, low viscosity antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112015008186A2 true BR112015008186A2 (pt) | 2017-09-19 |
Family
ID=50545202
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112015008186A BR112015008186A2 (pt) | 2012-10-25 | 2013-10-23 | formulação de um anticorpo estável e de baixa viscosidade |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US20150239970A1 (pt) |
| EP (1) | EP2911693A4 (pt) |
| JP (1) | JP2015536934A (pt) |
| KR (1) | KR20150070384A (pt) |
| CN (2) | CN106421782A (pt) |
| AU (1) | AU2013334740A1 (pt) |
| BR (1) | BR112015008186A2 (pt) |
| CA (1) | CA2885862A1 (pt) |
| HK (2) | HK1211840A1 (pt) |
| MX (1) | MX2015004668A (pt) |
| RU (1) | RU2015119547A (pt) |
| SG (1) | SG11201502659YA (pt) |
| WO (1) | WO2014066468A1 (pt) |
Families Citing this family (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6480338B2 (ja) | 2012-11-08 | 2019-03-06 | セセン バイオ， インコーポレイテッド | Ｉｌ−６アンタゴニストおよびその使用 |
| WO2014186350A1 (en) * | 2013-05-15 | 2014-11-20 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| US11548940B2 (en) | 2014-05-15 | 2023-01-10 | Rani Therapeutics, Llc | Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| TWI694836B (zh) | 2014-05-16 | 2020-06-01 | 英商葛蘭素史克智慧財產管理有限公司 | 抗體調配物 |
| PL2946765T3 (pl) | 2014-05-23 | 2017-08-31 | Ares Trading S.A. | Ciekła kompozycja farmaceutyczna |
| EP2946767B1 (en) | 2014-05-23 | 2016-10-05 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2572919T3 (es) | 2014-05-23 | 2016-06-03 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3215530B9 (en) | 2014-11-07 | 2020-09-09 | Sesen Bio, Inc. | Improved il-6 antibodies |
| AU2016261599B2 (en) * | 2015-05-08 | 2021-08-26 | Rani Therapeutics, Llc | Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device |
| JP2018529756A (ja) * | 2015-07-31 | 2018-10-11 | メディミューン リミテッド | ヘプシジン媒介性障害を治療するための方法 |
| KR102168005B1 (ko) * | 2015-08-19 | 2020-10-21 | 아스트라제네카 아베 | 안정한 항-ｉｆｎａｒ1 제형 |
| CN108718522A (zh) * | 2016-02-23 | 2018-10-30 | 赛森生物股份有限公司 | Il-6拮抗剂制剂及其用途 |
| US20190060241A1 (en) * | 2016-04-13 | 2019-02-28 | Medimmune, Llc | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| PE20190448A1 (es) * | 2016-06-30 | 2019-03-29 | Celltrion Inc | Formulacion farmaceutica liquida estable |
| CN109803640B (zh) * | 2016-08-10 | 2022-01-04 | 赛特瑞恩股份有限公司 | 稳定的液体抗流感病毒抗体医药调配物 |
| EP3518891A1 (en) * | 2016-09-27 | 2019-08-07 | Fresenius Kabi Deutschland GmbH | Liquid pharmaceutical composition |
| CN110177805B (zh) | 2016-10-19 | 2024-04-02 | 英温拉公司 | 抗体构建体 |
| EP3554543A4 (en) * | 2016-12-16 | 2020-09-02 | Samsung Bioepis Co., Ltd. | STABLE AQUEOUS COMPOSITION OF ANTI-C5 ANTIBODIES |
| WO2018115485A1 (en) | 2016-12-22 | 2018-06-28 | Pierfrancesco Tassone | A monoclonal antibody targeting a unique sialoglycosilated cancer-associated epitope of cd43 |
| SG11201906852XA (en) | 2017-02-01 | 2019-08-27 | Univ Yale | Treatment of diuretic resistance |
| BR112019018022A2 (pt) * | 2017-03-01 | 2020-06-02 | Medimmune Limited | Formulações de anticorpos monoclonais |
| CA3063324A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| RU2020125805A (ru) | 2018-01-05 | 2022-02-07 | Ново Нордиск А/С | Способы лечения опосредованного il-6 воспаления без иммунодепрессии |
| EP3802580A1 (en) | 2018-06-05 | 2021-04-14 | King's College London | Btnl3/8 targeting constructs for delivery of payloads to the gastrointestinal system |
| AU2019297498A1 (en) | 2018-07-05 | 2021-01-21 | Bayer Aktiengesellschaft | Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (FXIa) antibody |
| US20200061015A1 (en) * | 2018-08-23 | 2020-02-27 | Janssen Biotech, Inc. | Lipase Degradation Resistant Surfactants for Use in Large Molecule Therapeutic Formulations |
| CA3129901A1 (en) | 2019-02-18 | 2020-08-27 | Eli Lilly And Company | Therapeutic antibody formulation |
| CN111686247B (zh) * | 2019-03-13 | 2022-07-29 | 苏州康乃德生物医药有限公司 | 包含人白介素-4受体α的抗体的液体组合物 |
| MA55809A (fr) * | 2019-05-01 | 2022-03-09 | Novo Nordisk As | Formulation d'anticorps anti-il-6 |
| CN112915201B (zh) * | 2019-12-06 | 2023-06-27 | 珠海市丽珠单抗生物技术有限公司 | 包含抗il-17抗体的液体制剂 |
| WO2023169986A1 (en) * | 2022-03-07 | 2023-09-14 | Mabxience Research, S.L. | Stable formulations for antibodies |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2004229335C1 (en) * | 2003-04-04 | 2010-06-17 | Genentech, Inc. | High concentration antibody and protein formulations |
| JO3058B1 (ar) * | 2005-04-29 | 2017-03-15 | Applied Molecular Evolution Inc | الاجسام المضادة لمضادات -اي ال-6,تركيباتها طرقها واستعمالاتها |
| EP2314626A1 (en) * | 2005-12-09 | 2011-04-27 | UCB Pharma, S.A. | Antibody molecules having specificity for human IL-6 |
| JP5231810B2 (ja) * | 2005-12-28 | 2013-07-10 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| TW200831528A (en) * | 2006-11-30 | 2008-08-01 | Astrazeneca Ab | Compounds |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| TWI440469B (zh) * | 2008-09-26 | 2014-06-11 | Chugai Pharmaceutical Co Ltd | Improved antibody molecules |
| RU2650594C1 (ru) * | 2009-01-29 | 2018-04-17 | Медиммун, Ллк | Человеческие анти-il-6 антитела с пролонгированным периодом выведения in vivo и их применение при лечении онкологических, аутоиммунных заболеваний и воспалительных заболеваний |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| PL2624865T3 (pl) * | 2010-10-06 | 2018-11-30 | Regeneron Pharmaceuticals, Inc. | Stabilizowane preparaty zawierające przeciwciała przeciwko receptorowi interleukiny-4 (IL-4R) |
-
2013
- 2013-10-23 BR BR112015008186A patent/BR112015008186A2/pt not_active IP Right Cessation
- 2013-10-23 AU AU2013334740A patent/AU2013334740A1/en not_active Abandoned
- 2013-10-23 EP EP13848584.2A patent/EP2911693A4/en not_active Withdrawn
- 2013-10-23 CA CA2885862A patent/CA2885862A1/en not_active Abandoned
- 2013-10-23 RU RU2015119547A patent/RU2015119547A/ru not_active Application Discontinuation
- 2013-10-23 KR KR1020157013150A patent/KR20150070384A/ko not_active Application Discontinuation
- 2013-10-23 SG SG11201502659YA patent/SG11201502659YA/en unknown
- 2013-10-23 WO PCT/US2013/066313 patent/WO2014066468A1/en active Application Filing
- 2013-10-23 JP JP2015539744A patent/JP2015536934A/ja active Pending
- 2013-10-23 MX MX2015004668A patent/MX2015004668A/es unknown
- 2013-10-23 CN CN201610854508.7A patent/CN106421782A/zh not_active Withdrawn
- 2013-10-23 US US14/437,585 patent/US20150239970A1/en not_active Abandoned
- 2013-10-23 CN CN201380055029.3A patent/CN104768578A/zh active Pending
-
2015
- 2015-12-24 HK HK15112690.1A patent/HK1211840A1/xx unknown
-
2016
- 2016-03-01 HK HK16102332.5A patent/HK1214499A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014066468A8 (en) | 2015-04-09 |
| CA2885862A1 (en) | 2014-05-01 |
| EP2911693A4 (en) | 2016-04-27 |
| KR20150070384A (ko) | 2015-06-24 |
| HK1214499A1 (zh) | 2016-07-29 |
| RU2015119547A (ru) | 2016-12-20 |
| AU2013334740A8 (en) | 2015-04-09 |
| HK1211840A1 (en) | 2016-06-03 |
| WO2014066468A1 (en) | 2014-05-01 |
| US20150239970A1 (en) | 2015-08-27 |
| AU2013334740A1 (en) | 2015-04-02 |
| SG11201502659YA (en) | 2015-05-28 |
| JP2015536934A (ja) | 2015-12-24 |
| MX2015004668A (es) | 2015-07-23 |
| CN106421782A (zh) | 2017-02-22 |
| CN104768578A (zh) | 2015-07-08 |
| EP2911693A1 (en) | 2015-09-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B08F | Application fees: dismissal - article 86 of industrial property law | ||
| B08K | Lapse as no evidence of payment of the annual fee has been furnished to inpi (acc. art. 87) |