RU2731737C2 - Стабильный состав на основе антитела к ifnar1 - Google Patents
Стабильный состав на основе антитела к ifnar1 Download PDFInfo
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- RU2731737C2 RU2731737C2 RU2018107725A RU2018107725A RU2731737C2 RU 2731737 C2 RU2731737 C2 RU 2731737C2 RU 2018107725 A RU2018107725 A RU 2018107725A RU 2018107725 A RU2018107725 A RU 2018107725A RU 2731737 C2 RU2731737 C2 RU 2731737C2
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| CN113521276B (zh) * | 2021-07-13 | 2022-04-12 | 江苏荃信生物医药股份有限公司 | 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂 |
| CN113527490B (zh) * | 2021-07-13 | 2022-03-01 | 江苏荃信生物医药股份有限公司 | 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法 |
| WO2023284073A1 (zh) * | 2021-07-13 | 2023-01-19 | 江苏荃信生物医药股份有限公司 | 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法、抗人ifnar1单克隆抗体浓缩溶液的制备方法以及液体制剂 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2007118648A (ru) * | 2004-10-20 | 2008-11-27 | Дженентек, Инк. (Us) | Композиции антител |
| WO2009070642A1 (en) * | 2007-11-28 | 2009-06-04 | Medimmune, Llc | Protein formulation |
| WO2010056804A1 (en) * | 2008-11-12 | 2010-05-20 | Medimmune, Llc | Antibody formulation |
| WO2014186350A1 (en) * | 2013-05-15 | 2014-11-20 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| WO2015063180A1 (en) * | 2013-10-29 | 2015-05-07 | Novozymes Biopharma Dk A/S | Antibody composition |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US6713609B1 (en) * | 1996-07-16 | 2004-03-30 | Genentech, Inc. | Monoclonal antibodies to type I interferon receptor |
| EP1781705B1 (en) * | 2004-06-21 | 2014-10-08 | Medarex, L.L.C. | Interferon alpha receptor i antibodies and their uses |
| CN101553504A (zh) | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
| CA2692165A1 (en) | 2007-06-25 | 2008-12-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| HUE028958T2 (en) * | 2008-02-08 | 2017-01-30 | Medimmune Llc | Anti-ifnar1 antibodies with reduced fc ligand affinity |
| US20110152188A1 (en) * | 2009-12-23 | 2011-06-23 | Hanns-Christian Mahler | Pharmaceutical compositions of igf/i proteins |
| US20110223208A1 (en) * | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| KR20140103099A (ko) | 2011-10-12 | 2014-08-25 | 아센디스 파마 옵탈몰로지 디비젼 에이/에스 | 안구 병태의 예방 및 치료 |
| CA2951856A1 (en) | 2011-10-28 | 2013-05-02 | Integritybio Inc. | Protein formulations containing amino acids |
| US8883979B2 (en) * | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| BR112015008186A2 (pt) * | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| IL312865B2 (en) * | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| AU2015310879A1 (en) | 2014-09-03 | 2017-03-02 | Medimmune Limited | Stable anti-IL-4R-alpha antibody formulation |
| WO2016109822A1 (en) | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| RS64263B1 (sr) | 2015-08-19 | 2023-07-31 | Astrazeneca Ab | Stabilna anti-ifnar1 formulacija |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2007118648A (ru) * | 2004-10-20 | 2008-11-27 | Дженентек, Инк. (Us) | Композиции антител |
| WO2009070642A1 (en) * | 2007-11-28 | 2009-06-04 | Medimmune, Llc | Protein formulation |
| WO2010056804A1 (en) * | 2008-11-12 | 2010-05-20 | Medimmune, Llc | Antibody formulation |
| WO2014186350A1 (en) * | 2013-05-15 | 2014-11-20 | Medimmune Limited | Purification of recombinantly produced polypeptides |
| WO2015063180A1 (en) * | 2013-10-29 | 2015-05-07 | Novozymes Biopharma Dk A/S | Antibody composition |
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