JP2017531682A5 - - Google Patents
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- JP2017531682A5 JP2017531682A5 JP2017522169A JP2017522169A JP2017531682A5 JP 2017531682 A5 JP2017531682 A5 JP 2017531682A5 JP 2017522169 A JP2017522169 A JP 2017522169A JP 2017522169 A JP2017522169 A JP 2017522169A JP 2017531682 A5 JP2017531682 A5 JP 2017531682A5
- Authority
- JP
- Japan
- Prior art keywords
- excipient
- pharmaceutical composition
- composition according
- therapeutic protein
- 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.)
- Pending
Links
- 239000000546 pharmaceutical excipient Substances 0.000 claims 14
- 239000008194 pharmaceutical composition Substances 0.000 claims 12
- 238000000034 method Methods 0.000 claims 11
- 102000004169 proteins and genes Human genes 0.000 claims 11
- 108090000623 proteins and genes Proteins 0.000 claims 11
- 230000001225 therapeutic effect Effects 0.000 claims 11
- 239000008176 lyophilized powder Substances 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 6
- VEYYWZRYIYDQJM-ZETCQYMHSA-N N(2)-acetyl-L-lysine Chemical compound CC(=O)N[C@H](C([O-])=O)CCCC[NH3+] VEYYWZRYIYDQJM-ZETCQYMHSA-N 0.000 claims 5
- SNEIUMQYRCDYCH-LURJTMIESA-N N(alpha)-acetyl-L-arginine Chemical compound CC(=O)N[C@H](C(O)=O)CCCNC(N)=N SNEIUMQYRCDYCH-LURJTMIESA-N 0.000 claims 5
- KBOJOGQFRVVWBH-ZETCQYMHSA-N N-acetyl-L-histidine Chemical compound CC(=O)N[C@H](C(O)=O)CC1=CN=CN1 KBOJOGQFRVVWBH-ZETCQYMHSA-N 0.000 claims 5
- GNMSLDIYJOSUSW-LURJTMIESA-N N-acetyl-L-proline Chemical compound CC(=O)N1CCC[C@H]1C(O)=O GNMSLDIYJOSUSW-LURJTMIESA-N 0.000 claims 5
- 238000009472 formulation Methods 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019191701A JP6965321B2 (ja) | 2014-10-23 | 2019-10-21 | 医薬製剤の粘度低下 |
| JP2021170676A JP7411615B2 (ja) | 2014-10-23 | 2021-10-19 | 医薬製剤の粘度低下 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462067637P | 2014-10-23 | 2014-10-23 | |
| US62/067,637 | 2014-10-23 | ||
| PCT/US2015/056972 WO2016065181A1 (en) | 2014-10-23 | 2015-10-22 | Reducing viscosity of pharmaceutical formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019191701A Division JP6965321B2 (ja) | 2014-10-23 | 2019-10-21 | 医薬製剤の粘度低下 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2017531682A JP2017531682A (ja) | 2017-10-26 |
| JP2017531682A5 true JP2017531682A5 (enExample) | 2018-09-27 |
Family
ID=54427875
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017522169A Pending JP2017531682A (ja) | 2014-10-23 | 2015-10-22 | 医薬製剤の粘度低下 |
| JP2019191701A Active JP6965321B2 (ja) | 2014-10-23 | 2019-10-21 | 医薬製剤の粘度低下 |
| JP2021170676A Active JP7411615B2 (ja) | 2014-10-23 | 2021-10-19 | 医薬製剤の粘度低下 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019191701A Active JP6965321B2 (ja) | 2014-10-23 | 2019-10-21 | 医薬製剤の粘度低下 |
| JP2021170676A Active JP7411615B2 (ja) | 2014-10-23 | 2021-10-19 | 医薬製剤の粘度低下 |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11813328B2 (enExample) |
| EP (2) | EP3209332B1 (enExample) |
| JP (3) | JP2017531682A (enExample) |
| KR (1) | KR102534017B1 (enExample) |
| CN (2) | CN107206070B (enExample) |
| AU (2) | AU2015335743B2 (enExample) |
| BR (1) | BR112017008125B1 (enExample) |
| CA (1) | CA2964786C (enExample) |
| CL (2) | CL2017000984A1 (enExample) |
| EA (3) | EA038462B1 (enExample) |
| ES (1) | ES2964713T3 (enExample) |
| IL (2) | IL287947B2 (enExample) |
| MA (1) | MA54716A (enExample) |
| MX (2) | MX388858B (enExample) |
| SG (1) | SG11201703152RA (enExample) |
| WO (1) | WO2016065181A1 (enExample) |
| ZA (1) | ZA201702762B (enExample) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2964713T3 (es) | 2014-10-23 | 2024-04-09 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| JP7275027B2 (ja) * | 2016-10-06 | 2023-05-17 | アムジェン インコーポレイテッド | 粘度低下タンパク質医薬製剤 |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
| US12103979B2 (en) * | 2017-04-28 | 2024-10-01 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| MA48461A (fr) | 2017-04-28 | 2020-03-04 | Amgen Inc | Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation |
| US10646569B2 (en) | 2017-05-16 | 2020-05-12 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| IL271245B2 (en) | 2017-06-16 | 2023-10-01 | Zealand Pharma As | Dosing regimen for administration of glucagon-like peptide analog (GLP-2) 2 |
| US20200289621A1 (en) * | 2017-09-22 | 2020-09-17 | Asahi Kasei Pharma Corporation | Teriparatide-containing liquid pharmaceutical composition having excellent stability |
| WO2019106206A1 (en) | 2017-12-01 | 2019-06-06 | Fyb 202 Project Gmbh | Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody |
| WO2020008022A1 (en) | 2018-07-05 | 2020-01-09 | Bayer Aktiengesellschaft | METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY |
| MY204234A (en) | 2018-08-27 | 2024-08-16 | Regeneron Pharma | Use of raman spectroscopy in downstream purification |
| EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| CN113660927A (zh) | 2019-04-23 | 2021-11-16 | 安进公司 | 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度 |
| CR20220457A (es) * | 2020-02-13 | 2023-01-09 | Amgen Inc | Formulaciones de anticuerpos anti-tslp humanos y métodos de tratamiento de una enfermedad inflamatoria |
| KR102746418B1 (ko) * | 2020-12-03 | 2024-12-26 | 동국대학교 산학협력단 | N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물 |
| EP4674865A3 (en) * | 2021-03-09 | 2026-03-25 | GI Innovation, Inc. | Formulation of fusion protein including extracellular domain of alpha subunit of ige fc receptor |
| CA3214867A1 (en) * | 2021-04-09 | 2022-10-13 | Courtney O'DELL | Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations |
| TW202600593A (zh) * | 2024-02-16 | 2026-01-01 | 美商再生元醫藥公司 | 製造濃縮配製包括蛋白質之藥品物質之方法，以及該方法製造之濃縮配製之藥品物質 |
Family Cites Families (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5078997A (en) | 1988-07-13 | 1992-01-07 | Cetus Corporation | Pharmaceutical composition for interleukin-2 containing physiologically compatible stabilizers |
| US5955448A (en) | 1994-08-19 | 1999-09-21 | Quadrant Holdings Cambridge Limited | Method for stabilization of biological substances during drying and subsequent storage and compositions thereof |
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| EP1028748B1 (en) * | 1997-11-07 | 2003-05-02 | Chiron Corporation | Compositions providing for increased igf-i solubility |
| US6660843B1 (en) | 1998-10-23 | 2003-12-09 | Amgen Inc. | Modified peptides as therapeutic agents |
| US6159485A (en) * | 1999-01-08 | 2000-12-12 | Yugenic Limited Partnership | N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use |
| WO2001074397A1 (fr) | 2000-03-31 | 2001-10-11 | Kirin Beer Kabushiki Kaisha | Preparation en poudre destinee a etre administree par les muqueuses comprenant un medicament de forme polymere et presentant une stabilite de conservation amelioree |
| PT1343518E (pt) | 2000-11-07 | 2009-08-03 | Novartis Vaccines & Diagnostic | Composições de interferão estabilizadas |
| KR100911951B1 (ko) | 2001-08-23 | 2009-08-13 | 젠맵 에이/에스 | 인터루킨 15 (ｉｌ-15)에 대하여 특이적인 인간 항체 |
| CA2476934C (en) | 2002-02-27 | 2009-06-16 | Immunex Corporation | Stabilized tnfr-fc composition comprising arginine |
| AU2003293543A1 (en) | 2002-12-13 | 2004-07-09 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| JP2006516636A (ja) | 2003-01-30 | 2006-07-06 | メディミューン，インコーポレーテッド | 抗インテグリンαｖβ３抗体製剤及びその用途 |
| PT1610820E (pt) * | 2003-04-04 | 2010-12-16 | Novartis Ag | Formulações de elevada concentração de anticorpos e proteínas |
| US8084032B2 (en) | 2004-01-21 | 2011-12-27 | Ajinomoto Co., Inc. | Purification method which prevents denaturation of an antibody |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| WO2006081171A1 (en) | 2005-01-24 | 2006-08-03 | Amgen Inc. | Humanized anti-amyloid antibody |
| US8003108B2 (en) | 2005-05-03 | 2011-08-23 | Amgen Inc. | Sclerostin epitopes |
| US7592429B2 (en) | 2005-05-03 | 2009-09-22 | Ucb Sa | Sclerostin-binding antibody |
| JP5231810B2 (ja) | 2005-12-28 | 2013-07-10 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| CN101426527A (zh) * | 2006-02-03 | 2009-05-06 | 米迪缪尼有限公司 | 蛋白质制剂 |
| GB0603683D0 (en) | 2006-02-23 | 2006-04-05 | Novartis Ag | Organic compounds |
| CA2651453C (en) | 2006-05-11 | 2014-10-14 | Isis Pharmaceuticals, Inc. | 5'-modified bicyclic nucleic acid analogs |
| AR064333A1 (es) | 2006-12-14 | 2009-04-01 | Schering Corp | Anticuerpo anti-tslp de diseno |
| KR20100034015A (ko) | 2007-06-20 | 2010-03-31 | 아이알엠 엘엘씨 | 알레르기 질환 치료를 위한 방법 및 조성물 |
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| US7982016B2 (en) | 2007-09-10 | 2011-07-19 | Amgen Inc. | Antigen binding proteins capable of binding thymic stromal lymphopoietin |
| US8420081B2 (en) * | 2007-11-30 | 2013-04-16 | Abbvie, Inc. | Antibody formulations and methods of making same |
| SG2013054218A (en) * | 2008-01-15 | 2014-10-30 | Abbott Gmbh & Co Kg | Powdered protein compositions and methods of making same |
| TWI445716B (zh) | 2008-09-12 | 2014-07-21 | Rinat Neuroscience Corp | Ｐｃｓｋ９拮抗劑類 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| JP2011067202A (ja) | 2009-08-31 | 2011-04-07 | Sanyo Chem Ind Ltd | タンパク質水溶液の安定化剤、この安定化剤を含有するタンパク質水溶液及びタンパク質の安定化方法 |
| RU2558821C2 (ru) * | 2009-11-17 | 2015-08-10 | Ипсен Фарма С.А.С. | ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1 |
| DK2531218T3 (en) | 2010-02-04 | 2019-04-01 | Csl Behring Ag | immunoglobulin |
| SI3409289T1 (sl) * | 2010-02-26 | 2020-12-31 | Novo Nordisk A/S | Stabilni sestavki, ki vsebujejo protitelo |
| US20130171128A1 (en) * | 2010-03-02 | 2013-07-04 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| BR112012027828A2 (pt) | 2010-05-03 | 2016-08-09 | Genentech Inc | composição de matéria, artigo de fabricação e método de redução da viscosidade de uma formulação contendo proteína e de preparação de uma formulação aquosa contendo proteína |
| UY33679A (es) | 2010-10-22 | 2012-03-30 | Esbatech | Anticuerpos estables y solubles |
| JOP20200043A1 (ar) | 2011-05-10 | 2017-06-16 | Amgen Inc | طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول |
| JP6176849B2 (ja) | 2011-07-19 | 2017-08-09 | 中外製薬株式会社 | アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤 |
| AU2012328524B2 (en) * | 2011-10-28 | 2017-05-18 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| EA039663B1 (ru) | 2012-05-03 | 2022-02-24 | Амген Инк. | Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств |
| EP2863951A1 (en) | 2012-06-12 | 2015-04-29 | Boehringer Ingelheim International GmbH | Pharmaceutical formulation for a therapeutic antibody |
| US20150004174A1 (en) | 2013-06-28 | 2015-01-01 | Amgen Inc. | Methods for treating homozygous familial hypercholesterolemia |
| TWI694836B (zh) | 2014-05-16 | 2020-06-01 | 英商葛蘭素史克智慧財產管理有限公司 | 抗體調配物 |
| ES2964713T3 (es) | 2014-10-23 | 2024-04-09 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| CN121371151A (zh) | 2014-12-03 | 2026-01-23 | 瑞士杰特贝林生物制品有限公司 | 具有增加的稳定性的包含免疫球蛋白的药物产品 |
| IL307684B2 (en) | 2016-09-29 | 2025-04-01 | Amgen Inc | Low viscosity antigen binding proteins and methods for preparing them |
| JP7275027B2 (ja) | 2016-10-06 | 2023-05-17 | アムジェン インコーポレイテッド | 粘度低下タンパク質医薬製剤 |
| JP7377596B2 (ja) | 2017-02-22 | 2023-11-10 | アムジエン・インコーポレーテツド | 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法 |
-
2015
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
-
2017
- 2017-04-13 IL IL251726A patent/IL251726B/en unknown
- 2017-04-19 ZA ZA2017/02762A patent/ZA201702762B/en unknown
- 2017-04-20 CL CL2017000984A patent/CL2017000984A1/es unknown
- 2017-04-21 MX MX2021015789A patent/MX2021015789A/es unknown
-
2019
- 2019-08-02 CL CL2019002190A patent/CL2019002190A1/es unknown
- 2019-10-21 JP JP2019191701A patent/JP6965321B2/ja active Active
-
2021
- 2021-02-15 AU AU2021200990A patent/AU2021200990B2/en active Active
- 2021-10-19 JP JP2021170676A patent/JP7411615B2/ja active Active
-
2023
- 2023-10-24 US US18/383,121 patent/US12318447B2/en active Active
-
2025
- 2025-05-30 US US19/223,578 patent/US20250345421A1/en active Pending
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