JP2016512218A5 - - Google Patents
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- Publication number
- JP2016512218A5 JP2016512218A5 JP2015562255A JP2015562255A JP2016512218A5 JP 2016512218 A5 JP2016512218 A5 JP 2016512218A5 JP 2015562255 A JP2015562255 A JP 2015562255A JP 2015562255 A JP2015562255 A JP 2015562255A JP 2016512218 A5 JP2016512218 A5 JP 2016512218A5
- Authority
- JP
- Japan
- Prior art keywords
- optionally
- formulation
- antibody
- lymphoma
- lyophilized formulation
- 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
- 239000012931 lyophilized formulation Substances 0.000 claims 15
- 238000000034 method Methods 0.000 claims 15
- 238000009472 formulation Methods 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 12
- 238000001035 drying Methods 0.000 claims 9
- 206010025323 Lymphomas Diseases 0.000 claims 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 230000003204 osmotic effect Effects 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 3
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 2
- 208000024659 Hemostatic disease Diseases 0.000 claims 2
- 206010021245 Idiopathic thrombocytopenic purpura Diseases 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 2
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 2
- 229910019142 PO4 Inorganic materials 0.000 claims 2
- 241000721454 Pemphigus Species 0.000 claims 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
- 208000031981 Thrombocytopenic Idiopathic Purpura Diseases 0.000 claims 2
- 201000003710 autoimmune thrombocytopenic purpura Diseases 0.000 claims 2
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 230000008014 freezing Effects 0.000 claims 2
- 238000007710 freezing Methods 0.000 claims 2
- 239000012669 liquid formulation Substances 0.000 claims 2
- 208000003747 lymphoid leukemia Diseases 0.000 claims 2
- 239000002736 nonionic surfactant Substances 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 2
- 239000010452 phosphate Substances 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- 201000006845 reticulosarcoma Diseases 0.000 claims 2
- 208000029922 reticulum cell sarcoma Diseases 0.000 claims 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
- 208000012908 vascular hemostatic disease Diseases 0.000 claims 2
- 229950000815 veltuzumab Drugs 0.000 claims 2
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 1
- 206010059245 Angiopathy Diseases 0.000 claims 1
- 208000004736 B-Cell Leukemia Diseases 0.000 claims 1
- 208000036170 B-Cell Marginal Zone Lymphoma Diseases 0.000 claims 1
- 208000003950 B-cell lymphoma Diseases 0.000 claims 1
- 208000011691 Burkitt lymphomas Diseases 0.000 claims 1
- 208000004449 DNA Virus Infections Diseases 0.000 claims 1
- 206010015108 Epstein-Barr virus infection Diseases 0.000 claims 1
- 206010018691 Granuloma Diseases 0.000 claims 1
- 208000029433 Herpesviridae infectious disease Diseases 0.000 claims 1
- 208000018501 Lymphatic disease Diseases 0.000 claims 1
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 1
- 208000028018 Lymphocytic leukaemia Diseases 0.000 claims 1
- 208000030289 Lymphoproliferative disease Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 1
- 208000002774 Paraproteinemias Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 208000033014 Plasma cell tumor Diseases 0.000 claims 1
- 208000007452 Plasmacytoma Diseases 0.000 claims 1
- 208000013544 Platelet disease Diseases 0.000 claims 1
- 208000033766 Prolymphocytic Leukemia Diseases 0.000 claims 1
- 206010037549 Purpura Diseases 0.000 claims 1
- 241001672981 Purpura Species 0.000 claims 1
- 208000025747 Rheumatic disease Diseases 0.000 claims 1
- 206010043561 Thrombocytopenic purpura Diseases 0.000 claims 1
- 208000034841 Thrombotic Microangiopathies Diseases 0.000 claims 1
- 208000004062 Tumor Virus Infections Diseases 0.000 claims 1
- 208000016025 Waldenstroem macroglobulinemia Diseases 0.000 claims 1
- 208000033559 Waldenström macroglobulinemia Diseases 0.000 claims 1
- 208000015294 blood coagulation disease Diseases 0.000 claims 1
- 208000016363 blood protein disease Diseases 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 208000037615 chronic lymphocytic susceptibility to 2 leukemia Diseases 0.000 claims 1
- 208000018631 connective tissue disease Diseases 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 201000009277 hairy cell leukemia Diseases 0.000 claims 1
- 208000014951 hematologic disease Diseases 0.000 claims 1
- 208000031169 hemorrhagic disease Diseases 0.000 claims 1
- 208000025095 immunoproliferative disease Diseases 0.000 claims 1
- 208000018555 lymphatic system disease Diseases 0.000 claims 1
- 201000001268 lymphoproliferative syndrome Diseases 0.000 claims 1
- 230000003211 malignant effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 201000007924 marginal zone B-cell lymphoma Diseases 0.000 claims 1
- 208000021937 marginal zone lymphoma Diseases 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 208000010626 plasma cell neoplasm Diseases 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 206010043554 thrombocytopenia Diseases 0.000 claims 1
- 210000004881 tumor cell Anatomy 0.000 claims 1
- 208000019553 vascular disease Diseases 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361787225P | 2013-03-15 | 2013-03-15 | |
| US61/787,225 | 2013-03-15 | ||
| EP13159325.3 | 2013-03-15 | ||
| EP13159325 | 2013-03-15 | ||
| PCT/EP2014/055279 WO2014140361A1 (en) | 2013-03-15 | 2014-03-17 | Formulation of an antibody and use thereof |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2016512218A JP2016512218A (ja) | 2016-04-25 |
| JP2016512218A5 true JP2016512218A5 (cg-RX-API-DMAC10.html) | 2017-04-20 |
| JP6407174B2 JP6407174B2 (ja) | 2018-10-17 |
Family
ID=47900830
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015562255A Active JP6407174B2 (ja) | 2013-03-15 | 2014-03-17 | 抗体の配合物および該配合物の使用 |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US11576863B2 (cg-RX-API-DMAC10.html) |
| EP (1) | EP2970465B1 (cg-RX-API-DMAC10.html) |
| JP (1) | JP6407174B2 (cg-RX-API-DMAC10.html) |
| CN (1) | CN105189559B (cg-RX-API-DMAC10.html) |
| CA (1) | CA2903611C (cg-RX-API-DMAC10.html) |
| WO (1) | WO2014140361A1 (cg-RX-API-DMAC10.html) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6594272B2 (ja) * | 2016-09-02 | 2019-10-23 | 株式会社東芝 | 半導体装置及びその製造方法 |
| CN110022855B (zh) | 2016-10-07 | 2024-07-16 | 瑞泽恩制药公司 | 室温稳定的冻干蛋白质 |
| WO2020013126A1 (ja) * | 2018-07-09 | 2020-01-16 | 国立大学法人 熊本大学 | 環状一本鎖抗体 |
| MX2021007047A (es) * | 2018-12-14 | 2021-10-26 | Morphosys Ag | Formulaciones de anticuerpos. |
| PE20212185A1 (es) | 2019-02-18 | 2021-11-11 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos |
| RU2754760C2 (ru) * | 2019-04-02 | 2021-09-07 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция анти-il17a антитела и ее применение |
| CN114555117A (zh) * | 2019-10-12 | 2022-05-27 | 百奥泰生物制药股份有限公司 | 抗cd20抗体制剂及抗cd20抗体在治疗cd20阳性疾病中的应用 |
| CN112675126A (zh) * | 2019-10-18 | 2021-04-20 | 百奥泰生物制药股份有限公司 | 抗cd20抗体制剂及其应用 |
| CN113082203B (zh) * | 2020-01-09 | 2023-10-20 | 鲁南制药集团股份有限公司 | 一种免疫抑制剂单克隆抗体的液体制剂 |
| CN116782889A (zh) * | 2020-11-16 | 2023-09-19 | 生物技术欧洲股份公司 | 增强的制剂稳定性和改善的冻干工艺 |
| US20230414516A1 (en) * | 2020-11-16 | 2023-12-28 | BioNTech SE | Enhanced formulation stabilization and improved lyophilization processes |
| CN113855798A (zh) * | 2021-09-30 | 2021-12-31 | 佛山汉腾生物科技有限公司 | 抗cd20的抗体制剂 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| CA2226575C (en) * | 1995-07-27 | 2011-10-18 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| ATE454137T1 (de) | 2001-07-25 | 2010-01-15 | Facet Biotech Corp | Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| EP2377554A1 (en) | 2005-07-22 | 2011-10-19 | Amgen, Inc | Concentrated protein lyophilates, methods and uses |
| US20090208492A1 (en) | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| JP2010531340A (ja) * | 2007-07-10 | 2010-09-24 | エフ．ホフマン−ラ ロシュ アーゲー | 新規処方物 |
| WO2009080541A1 (en) * | 2007-12-21 | 2009-07-02 | F. Hoffmann-La Roche Ag | Antibody formulation |
| CN102159243B (zh) * | 2008-07-21 | 2015-08-19 | 免疫医疗公司 | 用于改良的治疗特征的抗体的结构变体 |
| JP5785077B2 (ja) | 2008-08-05 | 2015-09-24 | ワイス・エルエルシー | 崩壊温度より高温での凍結乾燥 |
| MX2011013722A (es) | 2009-06-18 | 2012-05-08 | Wyeth Llc | Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños. |
| WO2010148321A1 (en) * | 2009-06-18 | 2010-12-23 | Wyeth Llc | Slow dissolution method for reconstitution of lyophilized material |
| WO2011017070A1 (en) | 2009-07-28 | 2011-02-10 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
| AR078161A1 (es) * | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
| AU2012250924B2 (en) * | 2011-05-02 | 2017-05-25 | Immunomedics, Inc. | Ultrafiltration concentration of allotype selected antibodies for small-volume administration |
| EP2727602A1 (en) * | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
-
2014
- 2014-03-17 US US14/215,816 patent/US11576863B2/en active Active
- 2014-03-17 EP EP14710314.7A patent/EP2970465B1/en active Active
- 2014-03-17 US US14/773,478 patent/US11433029B2/en active Active
- 2014-03-17 CN CN201480025774.8A patent/CN105189559B/zh active Active
- 2014-03-17 JP JP2015562255A patent/JP6407174B2/ja active Active
- 2014-03-17 WO PCT/EP2014/055279 patent/WO2014140361A1/en not_active Ceased
- 2014-03-17 CA CA2903611A patent/CA2903611C/en active Active
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