JP2017095440A5 - - Google Patents
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- Publication number
- JP2017095440A5 JP2017095440A5 JP2016181594A JP2016181594A JP2017095440A5 JP 2017095440 A5 JP2017095440 A5 JP 2017095440A5 JP 2016181594 A JP2016181594 A JP 2016181594A JP 2016181594 A JP2016181594 A JP 2016181594A JP 2017095440 A5 JP2017095440 A5 JP 2017095440A5
- Authority
- JP
- Japan
- Prior art keywords
- protein
- excipient
- concentration
- formulation
- antibody
- 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
- 238000000034 method Methods 0.000 claims 34
- 239000000546 pharmaceutical excipient Substances 0.000 claims 27
- 102000004169 proteins and genes Human genes 0.000 claims 27
- 108090000623 proteins and genes Proteins 0.000 claims 27
- 239000000243 solution Substances 0.000 claims 18
- 238000009472 formulation Methods 0.000 claims 15
- 239000000203 mixture Substances 0.000 claims 15
- 239000000654 additive Substances 0.000 claims 13
- 230000000996 additive effect Effects 0.000 claims 13
- 238000000108 ultra-filtration Methods 0.000 claims 8
- 239000012465 retentate Substances 0.000 claims 7
- 239000012538 diafiltration buffer Substances 0.000 claims 6
- 239000004475 Arginine Substances 0.000 claims 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 3
- 229930006000 Sucrose Natural products 0.000 claims 3
- 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 3
- 150000001413 amino acids Chemical group 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- 238000011026 diafiltration Methods 0.000 claims 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 229940068968 polysorbate 80 Drugs 0.000 claims 3
- 239000005720 sucrose Substances 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 2
- 239000012895 dilution Substances 0.000 claims 2
- 238000010790 dilution Methods 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 239000002738 chelating agent Substances 0.000 claims 1
- 125000000600 disaccharide group Chemical group 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- -1 preferably Substances 0.000 claims 1
- 230000001737 promoting effect Effects 0.000 claims 1
- 238000011084 recovery Methods 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562222067P | 2015-09-22 | 2015-09-22 | |
| US62/222067 | 2015-09-22 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017095440A JP2017095440A (ja) | 2017-06-01 |
| JP2017095440A5 true JP2017095440A5 (enExample) | 2019-10-24 |
| JP6925111B2 JP6925111B2 (ja) | 2021-08-25 |
Family
ID=57045234
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016181594A Active JP6925111B2 (ja) | 2015-09-22 | 2016-09-16 | 治療用タンパク質製剤を調製する方法、およびそのような方法により生成される抗体製剤 |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20230134160A1 (enExample) |
| EP (1) | EP3352790A1 (enExample) |
| JP (1) | JP6925111B2 (enExample) |
| KR (2) | KR20200035496A (enExample) |
| CN (1) | CN108025072A (enExample) |
| AU (1) | AU2016329034B2 (enExample) |
| CA (1) | CA2999118C (enExample) |
| HK (1) | HK1255006A1 (enExample) |
| IL (1) | IL258311B (enExample) |
| MX (1) | MX2018003298A (enExample) |
| WO (1) | WO2017051273A1 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019517473A (ja) | 2016-05-27 | 2019-06-24 | アレクシオン ファーマシューティカルズ インコーポレイテッドＡｌｅｘｉｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 難治性全身型重症筋無力症の処置のための方法 |
| KR20200070355A (ko) | 2017-10-26 | 2020-06-17 | 알렉시온 파마슈티칼스, 인코포레이티드 | 발작성 야간 혈색소뇨 (pnh) 및 비정형 용혈성 요독 증후군 (ahus)의 치료를 위한 항-c5 항체의 투여량 및 투여 |
| CN112088013B (zh) * | 2018-03-26 | 2024-12-06 | 勃林格殷格翰动物保健美国有限公司 | 制备免疫原性组合物的方法 |
| NZ770284A (en) | 2018-05-10 | 2025-11-28 | Regeneron Pharma | High concentration vegf receptor fusion protein containing formulations |
| WO2020006266A1 (en) * | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| EP3837273B1 (en) * | 2018-08-14 | 2025-09-24 | Bristol-Myers Squibb Company | Improved protein recovery |
| CN111110841A (zh) * | 2018-10-31 | 2020-05-08 | 上海君实生物医药科技股份有限公司 | 含有抗pcsk9抗体的稳定制剂 |
| EP3782666B1 (en) | 2019-01-24 | 2021-08-11 | Magenta Medical Ltd. | Manufacturing an impeller |
| TWI871300B (zh) * | 2019-01-28 | 2025-02-01 | 美商安進公司 | 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程 |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| WO2021171310A1 (en) * | 2020-02-24 | 2021-09-02 | Indian Institute Of Technology Delhi | A system for real-time monitoring of protein and excipients |
| CN111944046B (zh) * | 2020-08-28 | 2021-04-09 | 江苏荃信生物医药有限公司 | 高浓度、低粘度抗人il-23单克隆抗体溶液的制备方法 |
| WO2022041390A1 (zh) * | 2020-08-28 | 2022-03-03 | 江苏荃信生物医药股份有限公司 | 包含高浓度抗人白介素23单克隆抗体的低粘度液体制剂及其制备方法 |
| KR20230127292A (ko) * | 2020-12-30 | 2023-08-31 | 아이-맵 바이오파마 컴파니 리미티드 | 항-cd73 항체의 제제 |
| CN114014929B (zh) * | 2021-11-04 | 2022-07-19 | 江苏荃信生物医药股份有限公司 | 一种抗人白介素-33单克隆抗体浓缩溶液的制备方法 |
| JP2025530825A (ja) | 2022-09-14 | 2025-09-17 | マジェンタ・メディカル・リミテッド | 心室補助デバイスの湾曲 |
| WO2024165043A1 (en) * | 2023-02-08 | 2024-08-15 | Beigene Switzerland Gmbh | Preparation methods for a highly concentrated pd1 antibody solution by applying single-pass tangential flow filtration (sptff) |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9415102B2 (en) * | 2002-09-06 | 2016-08-16 | Alexion Pharmaceuticals, Inc. | High concentration formulations of anti-C5 antibodies |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| DK1865986T3 (en) * | 2005-03-08 | 2016-04-11 | Pfizer Prod Inc | The anti-CTLA-4 antibody compositions |
| 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 |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| WO2010042705A1 (en) * | 2008-10-09 | 2010-04-15 | Medimmune, Llc | Antibody formulation |
| US8298535B2 (en) * | 2010-02-24 | 2012-10-30 | Rinat Neuroscience Corp. | Anti-IL-7 receptor antibodies |
| EA022220B1 (ru) * | 2010-02-24 | 2015-11-30 | Сюменекс А/С | Способ получения и очистки рекомбинантной лизосомальной альфа-маннозидазы |
| WO2012168491A1 (en) * | 2011-06-10 | 2012-12-13 | Novartis Ag | Pharmaceutical formulations of pcsk9 antagonists |
| EP2583980A1 (en) * | 2011-10-19 | 2013-04-24 | Effimune | Antibodies directed against the alpha chain of IL7 receptor - their use for the preparation of drug candidates |
| BR112014028129A2 (pt) * | 2012-05-14 | 2017-06-27 | Novo Nordisk As | soluções de proteína estabilizadas |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| EP2727602A1 (en) * | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
-
2016
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en active Active
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en not_active Ceased
- 2016-09-08 HK HK18114122.2A patent/HK1255006A1/zh unknown
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-08 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko not_active Ceased
- 2016-09-08 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-16 JP JP2016181594A patent/JP6925111B2/ja active Active
-
2018
- 2018-03-22 IL IL258311A patent/IL258311B/en active IP Right Grant
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