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 (OSRAM) | 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 (OSRAM) |
| EP (1) | EP2129401B8 (OSRAM) |
| JP (2) | JP5577098B2 (OSRAM) |
| AU (1) | AU2007338791B2 (OSRAM) |
| CA (2) | CA2790018C (OSRAM) |
| ES (1) | ES2748526T3 (OSRAM) |
| MX (1) | MX2009006594A (OSRAM) |
| WO (1) | WO2008079290A2 (OSRAM) |
Families Citing this family (50)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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. |
| AU2006259664A1 (en) | 2005-06-14 | 2006-12-28 | Amgen Inc. | Self-buffering protein formulations |
| US7833527B2 (en) | 2006-10-02 | 2010-11-16 | Amgen Inc. | Methods of treating psoriasis using IL-17 Receptor A antibodies |
| EP4104821A1 (en) * | 2008-10-29 | 2022-12-21 | Ablynx N.V. | 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 |
| WO2010100135A1 (en) | 2009-03-05 | 2010-09-10 | Ablynx N.V. | Novel antigen binding dimer-complexes, methods of making/avoiding and uses thereof |
| SI2448970T1 (sl) | 2009-05-04 | 2014-11-28 | Abbvie Research B.V. | Protitelesa proti živčnemu rastnemu faktorju (NGF) s povečano stabilnostjo in vivo |
| EP2435027B1 (en) | 2009-05-27 | 2016-10-05 | Alkermes Pharma Ireland Limited | Reduction of flake-like aggregation in nanoparticulate meloxicam compositions |
| UA104762C2 (ru) * | 2009-06-12 | 2014-03-11 | ХЕЛСИНН ТЕРАПЬЮТИКС (Ю.Эс.), ИНК. | Раствор для инъекции или инфузии ипаморелина диацетата |
| WO2011026945A1 (en) | 2009-09-03 | 2011-03-10 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| DK2523688T3 (en) | 2010-01-15 | 2017-12-04 | Kirin-Amgen Inc | ANTIBODY FORMULATION AND THERAPEUTIC REGIMENS |
| TWI505838B (zh) * | 2010-01-20 | 2015-11-01 | Chugai Pharmaceutical Co Ltd | Stabilized antibody solution containing |
| JP2014516924A (ja) * | 2011-04-07 | 2014-07-17 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | 粘度が低減された処方物 |
| US10493151B2 (en) | 2011-10-18 | 2019-12-03 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with sodium chloride |
| RS59179B1 (sr) | 2011-10-18 | 2019-10-31 | Coherus Biosciences Inc | Formulacije etanercepta stabilizovane jonima magnezijuma |
| EP2771295B1 (en) | 2011-10-25 | 2017-11-22 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| MX352823B (es) | 2011-10-28 | 2017-12-04 | Integritybio Inc | Formulaciones de proteinas que contienen aminoacidos. |
| BR112015000229A2 (pt) | 2012-07-09 | 2017-06-27 | Coherus Biosciences Inc | formulações aquosas estáveis de etanercept |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| RS57013B1 (sr) | 2012-09-11 | 2018-05-31 | Coherus Biosciences Inc | Korektno savijeni etanercept sa visokom čistoćom i odličnim prinosom |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| US9707153B2 (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 |
| US9839579B2 (en) | 2013-04-24 | 2017-12-12 | 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 |
| US9700485B2 (en) | 2013-04-24 | 2017-07-11 | 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 |
| US9717649B2 (en) * | 2013-04-24 | 2017-08-01 | 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 |
| US9849066B2 (en) | 2013-04-24 | 2017-12-26 | 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 |
| US9713572B2 (en) | 2013-04-24 | 2017-07-25 | 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 |
| DK3380525T3 (da) * | 2015-11-25 | 2024-01-29 | Immunogen Inc | Farmaceutiske formuleringer og fremgangsmåder til anvendelse deraf |
| 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 |
| PT3468997T (pt) * | 2016-06-08 | 2023-12-07 | Debra Zack | Tratamento de doenças relacionadas com igg4 com anticorpos anti-cd19 com ligação cruzada a cd32b |
| CN109982685B (zh) | 2016-10-21 | 2022-03-11 | 美国安进公司 | 药物配制品及其制备方法 |
| WO2018200533A1 (en) | 2017-04-28 | 2018-11-01 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| JOP20190255A1 (ar) * | 2017-04-28 | 2019-10-27 | Amgen Inc | صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| AU2018263868A1 (en) | 2017-05-02 | 2019-12-12 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
| JP7407118B2 (ja) * | 2018-02-08 | 2023-12-28 | アムジェン インコーポレイテッド | 低ｐＨ医薬抗体製剤 |
| CA3118144A1 (en) | 2018-11-07 | 2020-05-14 | Merck Sharp & Dohme Corp. | Co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies |
| TWI851622B (zh) * | 2018-11-16 | 2024-08-11 | 南韓商三星Ｂｉｏｅｐｉｓ股份有限公司 | 包含蛋白質的穩定液體組成物 |
| PE20212185A1 (es) | 2019-02-18 | 2021-11-11 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos |
| US20220218607A1 (en) * | 2019-04-23 | 2022-07-14 | Sanofi | Stable, low-viscosity antibody formulations and uses thereof |
| AU2021319203A1 (en) * | 2020-07-30 | 2023-03-02 | Silver Creek Pharmaceuticals, Inc. | Chimeric proteins and methods of use for treatment of central nervous system disorders |
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| US4447233A (en) * | 1981-04-10 | 1984-05-08 | Parker-Hannifin Corporation | Medication infusion pump |
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| JP5290489B2 (ja) * | 2001-11-08 | 2013-09-18 | アッヴィ・バイオセラピューティクス・インコーポレイテッド | Ｉｇｇ抗体の安定な液体医薬製剤 |
| UA80447C2 (en) * | 2002-10-08 | 2007-09-25 | Methods for treating pain by administering nerve growth factor antagonist and opioid analgesic | |
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| DK1543735T3 (en) * | 2003-12-20 | 2015-11-02 | Nestec Sa | FOOD COMPOSITION FOR HEALTH CARE |
| JPWO2005063291A1 (ja) * | 2003-12-25 | 2007-07-19 | 麒麟麦酒株式会社 | 抗体を含有する安定な水性医薬製剤 |
| 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. |
| AU2006259664A1 (en) * | 2005-06-14 | 2006-12-28 | Amgen Inc. | Self-buffering protein formulations |
-
2007
- 2007-12-19 EP EP07863175.1A patent/EP2129401B8/en active Active
- 2007-12-19 MX MX2009006594A patent/MX2009006594A/es active IP Right Grant
- 2007-12-19 ES ES07863175T patent/ES2748526T3/es active Active
- 2007-12-19 CA CA2790018A patent/CA2790018C/en active Active
- 2007-12-19 JP JP2009542922A patent/JP5577098B2/ja active Active
- 2007-12-19 AU AU2007338791A patent/AU2007338791B2/en active Active
- 2007-12-19 US US12/004,114 patent/US20080213282A1/en not_active Abandoned
- 2007-12-19 CA CA2672902A patent/CA2672902C/en active Active
- 2007-12-19 WO PCT/US2007/026060 patent/WO2008079290A2/en not_active Ceased
-
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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