JP2010513522A5 - - Google Patents
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- Publication number
- JP2010513522A5 JP2010513522A5 JP2009542922A JP2009542922A JP2010513522A5 JP 2010513522 A5 JP2010513522 A5 JP 2010513522A5 JP 2009542922 A JP2009542922 A JP 2009542922A JP 2009542922 A JP2009542922 A JP 2009542922A JP 2010513522 A5 JP2010513522 A5 JP 2010513522A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- antibody
- antigen
- binding fragment
- concentration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 claims 42
- 238000009472 formulation Methods 0.000 claims 41
- 239000000427 antigen Substances 0.000 claims 29
- 102000036639 antigens Human genes 0.000 claims 29
- 108091007433 antigens Proteins 0.000 claims 29
- 239000012634 fragment Substances 0.000 claims 29
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 claims 15
- 108010025020 Nerve Growth Factor Proteins 0.000 claims 13
- 102000015336 Nerve Growth Factor Human genes 0.000 claims 13
- 229940053128 nerve growth factor Drugs 0.000 claims 13
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 9
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 8
- 239000008351 acetate buffer Substances 0.000 claims 8
- 239000000872 buffer Substances 0.000 claims 8
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 5
- 235000013922 glutamic acid Nutrition 0.000 claims 5
- 239000004220 glutamic acid Substances 0.000 claims 5
- 229940009098 aspartate Drugs 0.000 claims 4
- 235000003704 aspartic acid Nutrition 0.000 claims 4
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims 4
- 229940049906 glutamate Drugs 0.000 claims 4
- 229930195712 glutamate Natural products 0.000 claims 4
- 239000003102 growth factor Substances 0.000 claims 4
- 229920005862 polyol Polymers 0.000 claims 4
- 150000003077 polyols Chemical class 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- 208000002193 Pain Diseases 0.000 claims 3
- 239000007864 aqueous solution Substances 0.000 claims 3
- 208000004296 neuralgia Diseases 0.000 claims 3
- 208000021722 neuropathic pain Diseases 0.000 claims 3
- 230000035945 sensitivity Effects 0.000 claims 3
- 208000024891 symptom Diseases 0.000 claims 3
- 239000007853 buffer solution Substances 0.000 claims 2
- 229940071643 prefilled syringe Drugs 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 1
- 150000001510 aspartic acids Chemical class 0.000 claims 1
- PXEDJBXQKAGXNJ-QTNFYWBSSA-L disodium L-glutamate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](N)CCC([O-])=O PXEDJBXQKAGXNJ-QTNFYWBSSA-L 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 235000013923 monosodium glutamate Nutrition 0.000 claims 1
- 229920001184 polypeptide Polymers 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 239000001632 sodium acetate Substances 0.000 claims 1
- 235000017281 sodium acetate Nutrition 0.000 claims 1
- 229940073490 sodium glutamate Drugs 0.000 claims 1
- WTWSHHITWMVLBX-DKWTVANSSA-M sodium;(2s)-2-aminobutanedioate;hydron Chemical compound [Na+].[O-]C(=O)[C@@H](N)CC(O)=O WTWSHHITWMVLBX-DKWTVANSSA-M 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US87680106P | 2006-12-21 | 2006-12-21 | |
| US60/876,801 | 2006-12-21 | ||
| PCT/US2007/026060 WO2008079290A2 (en) | 2006-12-21 | 2007-12-19 | Stable buffered formulations containing polypeptides |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013109920A Division JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2010513522A JP2010513522A (ja) | 2010-04-30 |
| JP2010513522A5 true JP2010513522A5 (https=) | 2011-02-10 |
| JP5577098B2 JP5577098B2 (ja) | 2014-08-20 |
Family
ID=39563088
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2009542922A Active JP5577098B2 (ja) | 2006-12-21 | 2007-12-19 | ポリペプチドを含有する安定な緩衝化された製剤 |
| JP2013109920A Pending JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013109920A Pending JP2013216659A (ja) | 2006-12-21 | 2013-05-24 | ポリペプチドを含有する安定な緩衝化された製剤 |
Country Status (8)
| Country | Link |
|---|---|
| US (3) | US20080213282A1 (https=) |
| EP (1) | EP2129401B8 (https=) |
| JP (2) | JP5577098B2 (https=) |
| AU (1) | AU2007338791B2 (https=) |
| CA (2) | CA2790018C (https=) |
| ES (1) | ES2748526T3 (https=) |
| MX (1) | MX2009006594A (https=) |
| WO (1) | WO2008079290A2 (https=) |
Families Citing this family (54)
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| ITRM20030601A1 (it) * | 2003-12-24 | 2005-06-25 | Lay Line Genomics Spa | Metodo per l'umanizzazione di anticorpi e anticorpi umanizzati con esso ottenuti. |
| ITRM20050290A1 (it) | 2005-06-07 | 2006-12-08 | Lay Line Genomics Spa | Uso di molecole in grado di inibire il legame tra ngf e il suo recettore trka come analgesici ad effetto prolungato. |
| BRPI0611901A2 (pt) | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| US7767206B2 (en) | 2006-10-02 | 2010-08-03 | Amgen Inc. | Neutralizing determinants of IL-17 Receptor A and antibodies that bind thereto |
| CA2738243C (en) * | 2008-10-29 | 2020-09-29 | Wyeth Llc | Formulations of single domain antigen binding molecules |
| US9265834B2 (en) | 2009-03-05 | 2016-02-23 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| US10005830B2 (en) | 2009-03-05 | 2018-06-26 | Ablynx N.V. | Antigen binding dimer-complexes, methods of making/avoiding and uses thereof |
| SG175436A1 (en) | 2009-05-04 | 2011-12-29 | Abbott Res Bv | Antibodies against nerve growth factor (ngf) with enhanced in vivo stability |
| EP3167875A1 (en) | 2009-05-27 | 2017-05-17 | Alkermes Pharma Ireland Limited | Reduction of flake-like aggregation in nanoparticulate meloxicam compositions |
| PE20121064A1 (es) * | 2009-06-12 | 2012-09-03 | Helsinn Therapeutics Us Inc | Solucion de inyeccion o infusion de diacetato de ipamorelin |
| LT2805731T (lt) | 2009-09-03 | 2019-02-11 | Ablynx N.V. | Stabilios polipeptidų kompozicijos ir jų panaudojimas |
| PH12012501364A1 (en) * | 2010-01-15 | 2012-10-22 | Amgen K A Inc | Antibody formulation and therapeutic regimens |
| AR080428A1 (es) * | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| SG193963A1 (en) * | 2011-04-07 | 2013-11-29 | Glaxosmithkline Llc | Formulations with reduced viscosity |
| BR112014009146A8 (pt) * | 2011-10-18 | 2017-06-20 | Coherus Biosciences Inc | formulações de etanercepte estabilizadas com aminoácidos |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| WO2013063277A1 (en) | 2011-10-25 | 2013-05-02 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| CN108771655A (zh) | 2011-10-28 | 2018-11-09 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
| HK1209343A1 (en) | 2012-07-09 | 2016-04-01 | Coherus Biosciences, Inc. | Etanercept formulations exhibiting marked reduction in sub-visible particles |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| SI2895188T1 (en) | 2012-09-11 | 2018-05-31 | Coherus Biosciences, Inc. | CORRECTED QUALITY ETHANERCEPT WITH HIGH QUALITY AND EXCELLENT EXPERIENCE |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| US9849066B2 (en) | 2013-04-24 | 2017-12-26 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9717648B2 (en) | 2013-04-24 | 2017-08-01 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707155B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9839579B2 (en) | 2013-04-24 | 2017-12-12 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9717649B2 (en) * | 2013-04-24 | 2017-08-01 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9713572B2 (en) | 2013-04-24 | 2017-07-25 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707154B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9700486B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9700485B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9707153B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| US9603775B2 (en) | 2013-04-24 | 2017-03-28 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| GB2516808A (en) | 2013-05-31 | 2015-02-11 | Innova Biosciences Ltd | Antibody composition and buffer system therefor |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| US20170189548A1 (en) * | 2015-11-25 | 2017-07-06 | Immunogen, Inc. | Pharmaceutical formulations and methods of use thereof |
| MX2018011675A (es) * | 2016-03-25 | 2019-01-10 | Astellas Pharma Inc | Composicion farmaceutica que comprende un fragmento fab' pegilado de anticuerpo anti-ngf humano. |
| EP3443346B1 (en) * | 2016-04-13 | 2023-08-30 | Medimmune, LLC | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
| WO2017214452A1 (en) * | 2016-06-08 | 2017-12-14 | Xencor, Inc. | Treatment of igg4-related diseases with anti-cd19 antibodies crossbinding to cd32b |
| PT3528787T (pt) | 2016-10-21 | 2026-03-11 | Amgen Inc | Formulações farmacêuticas e métodos para produzir as mesmas |
| SI4190355T1 (sl) * | 2017-04-28 | 2025-02-28 | Amgen Inc. | Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe |
| EP3615065A1 (en) | 2017-04-28 | 2020-03-04 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| JP7382232B2 (ja) | 2017-05-02 | 2023-11-16 | メルク・シャープ・アンド・ドーム・エルエルシー | 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤 |
| MA51747A (fr) * | 2018-02-08 | 2020-12-16 | Amgen Inc | Formulation d'anticorps pharmaceutique à ph faible |
| WO2020081408A1 (en) | 2018-10-18 | 2020-04-23 | Merck Sharp & Dohme Corp. | Formulations of anti-rsv antibodies and methods of use thereof |
| MX2021004928A (es) | 2018-10-31 | 2021-06-08 | Merck Sharp & Dohme Llc | Cristales de anticuerpo anti-pd-1 humano y metodos de uso de los mismos. |
| EP3876990A4 (en) | 2018-11-07 | 2023-09-06 | Merck Sharp & Dohme LLC | CO-FORMULATIONS OF ANTI-LAG3 ANTIBODIES AND ANTI-PD-1 ANTIBODIES |
| AU2019378544A1 (en) * | 2018-11-16 | 2021-06-10 | Samsung Bioepis Co., Ltd. | Stable liquid composition comprising protein |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| BR112021021099A2 (pt) * | 2019-04-23 | 2021-12-14 | Sanofi Sa | Formulações de anticorpos estáveis, de baixa viscosidade, e usos das mesmas |
| US11806320B2 (en) * | 2020-02-19 | 2023-11-07 | Endo Ventures Limited | Isoproterenol compositions and methods |
| EP4159236A4 (en) | 2020-05-29 | 2024-08-21 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing formulation |
| US20220031812A1 (en) * | 2020-07-30 | 2022-02-03 | Silver Creek Pharmaceuticals, Inc. | Chimeric Proteins and Methods of Use for Treatment of Central Nervous System Disorders |
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| EP1543735B1 (en) * | 2003-12-20 | 2015-10-07 | Nestec S.A. | Nutritional composition for wound healing |
| EP1712240B1 (en) * | 2003-12-25 | 2015-09-09 | Kyowa Hakko Kirin Co., Ltd. | Stable water-based medicinal preparation containing antibody |
| JP2006001912A (ja) * | 2004-06-21 | 2006-01-05 | Chugai Pharmaceut Co Ltd | タンパク質製剤の安定化方法 |
| ITRM20050290A1 (it) * | 2005-06-07 | 2006-12-08 | Lay Line Genomics Spa | Uso di molecole in grado di inibire il legame tra ngf e il suo recettore trka come analgesici ad effetto prolungato. |
| BRPI0611901A2 (pt) * | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
-
2007
- 2007-12-19 CA CA2790018A patent/CA2790018C/en active Active
- 2007-12-19 JP JP2009542922A patent/JP5577098B2/ja active Active
- 2007-12-19 ES ES07863175T patent/ES2748526T3/es active Active
- 2007-12-19 MX MX2009006594A patent/MX2009006594A/es active IP Right Grant
- 2007-12-19 US US12/004,114 patent/US20080213282A1/en not_active Abandoned
- 2007-12-19 WO PCT/US2007/026060 patent/WO2008079290A2/en not_active Ceased
- 2007-12-19 EP EP07863175.1A patent/EP2129401B8/en active Active
- 2007-12-19 CA CA2672902A patent/CA2672902C/en active Active
- 2007-12-19 AU AU2007338791A patent/AU2007338791B2/en active Active
-
2013
- 2013-05-24 JP JP2013109920A patent/JP2013216659A/ja active Pending
-
2015
- 2015-05-05 US US14/704,853 patent/US20150315271A1/en not_active Abandoned
-
2019
- 2019-05-22 US US16/419,527 patent/US20190345238A1/en not_active Abandoned
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