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) | CN114569716A (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 |
|---|---|---|---|---|
| MX388858B (es) | 2014-10-23 | 2025-03-20 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| WO2018067987A1 (en) * | 2016-10-06 | 2018-04-12 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| 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 |
| ES3036143T3 (en) * | 2017-04-28 | 2025-09-15 | Amgen Inc | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| WO2018200533A1 (en) | 2017-04-28 | 2018-11-01 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| CA3063324A1 (en) | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| DK3881861T3 (da) | 2017-06-16 | 2024-09-09 | Zealand Pharma As | Doseringsregimer for indgivelse af glukagonlignende peptid-2- (GLP-2)-analoger |
| JP6577683B2 (ja) * | 2017-09-22 | 2019-09-18 | 旭化成ファーマ株式会社 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| 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 |
| US20210292434A1 (en) | 2018-07-05 | 2021-09-23 | Bayer Aktiengesellschaft | NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES |
| CN112218877B (zh) | 2018-08-27 | 2025-07-25 | 瑞泽恩制药公司 | 拉曼光谱在下游纯化中的应用 |
| EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| US20220226477A1 (en) * | 2019-04-23 | 2022-07-21 | Amgen Inc. | The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations |
| KR20220140772A (ko) * | 2020-02-13 | 2022-10-18 | 암젠 인크 | 인간 항-tslp 항체 제형 및 염증성 질환의 치료 방법 |
| KR102746418B1 (ko) * | 2020-12-03 | 2024-12-26 | 동국대학교 산학협력단 | N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물 |
| EP4306103B1 (en) * | 2021-03-09 | 2025-12-24 | GI Innovation, Inc. | Formulation of fusion protein including extracellular domain of alpha subunit of ige fc receptor |
| EP4319795A4 (en) * | 2021-04-09 | 2025-03-05 | Avantor Performance Materials, LLC | Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations |
| WO2025175164A1 (en) * | 2024-02-16 | 2025-08-21 | Regeneron Pharmaceuticals, Inc. | Methods of producing concentrated formulated drug substances comprising proteins, and concentrated formulated drug substance made by the methods |
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| 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 |
| JP2001522814A (ja) * | 1997-11-07 | 2001-11-20 | カイロン コーポレイション | 増大されたｉｇｆ−ｉ溶解性を提供する組成物 |
| US6767892B1 (en) | 1997-11-07 | 2004-07-27 | Chrion 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 |
| EP1273306A4 (en) * | 2000-03-31 | 2005-06-22 | Kirin Brewery | POWDER PREPARATION FOR TRANSMUCOSAL ADMINISTRATION CONTAINING A POLYMERIC FORM OF AN ACTIVE SUBSTANCE AND HAVING AN IMPROVED STORAGE STABILITY |
| WO2002038170A2 (en) | 2000-11-07 | 2002-05-16 | Chiron Corporation | Stabilized inteferon compositions |
| PL217752B1 (pl) | 2001-08-23 | 2014-08-29 | Genmab As | Izolowane ludzkie przeciwciało monoklonalne wobec IL-15 lub jego fragment wiążący antygen i związane z nimi hybrydoma, kompozycja farmaceutyczna oraz zastosowania medyczne |
| PL215168B1 (pl) | 2002-02-27 | 2013-10-31 | Immunex Corp | Formulacja polipeptydowa |
| 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 |
| HRP20050934B1 (hr) | 2003-04-04 | 2014-09-26 | Genentech, Inc. | Formulacije s visokom koncentracijom antitijela i proteina |
| 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 |
| CA2589860A1 (en) | 2005-01-24 | 2006-08-03 | Amgen Inc. | Humanized anti-amyloid antibody |
| US7592429B2 (en) | 2005-05-03 | 2009-09-22 | Ucb Sa | Sclerostin-binding antibody |
| US8003108B2 (en) | 2005-05-03 | 2011-08-23 | Amgen Inc. | Sclerostin epitopes |
| EP1977763A4 (en) * | 2005-12-28 | 2010-06-02 | Chugai Pharmaceutical Co Ltd | ANTIBODY-CONTAINING STABILIZING PREPARATION |
| 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 |
| JP5441688B2 (ja) | 2006-05-11 | 2014-03-12 | アイシス ファーマシューティカルズ， インコーポレーテッド | ５’修飾二環式核酸類似体 |
| MX2009006471A (es) | 2006-12-14 | 2009-06-26 | Schering Corp | Anticuerpo anti especifico de linfopoyetina estromal timica de diseño. |
| AR067045A1 (es) | 2007-06-20 | 2009-09-30 | Irm Llc | Metodos y composiciones para el tratamiento de enfermedades alergicas |
| 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 |
| NZ622583A (en) * | 2007-11-30 | 2015-08-28 | Abbvie Biotechnology Ltd | Protein formulations and methods of making same |
| BRPI0907186A2 (pt) * | 2008-01-15 | 2015-07-14 | Abbott Gmbh & Co Kg | Composições proteicas pulverizadas e métodos para sua produção |
| TWI516501B (zh) | 2008-09-12 | 2016-01-11 | 禮納特神經系統科學公司 | 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 |
| KR101614983B1 (ko) * | 2009-11-17 | 2016-04-22 | 입센 파마 에스.에이.에스 | Ｈｇｈ 및 ｒｈｉｇｆ―１의 조합물을 위한 제제 |
| CA2788863C (en) | 2010-02-04 | 2020-07-07 | Csl Behring Ag | Immunoglobulin preparation |
| CN107496917B (zh) * | 2010-02-26 | 2021-06-11 | 诺沃—诺迪斯克有限公司 | 包含稳定抗体的组合物 |
| WO2011109415A2 (en) | 2010-03-02 | 2011-09-09 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| RU2012151500A (ru) * | 2010-05-03 | 2014-06-10 | Дженентек, Инк. | Композиции и способы, пригодные для снижения вязкости белковосодержащих составов |
| AR083495A1 (es) | 2010-10-22 | 2013-02-27 | Esbatech Alcon Biomed Res Unit | Anticuerpos estables y solubles |
| JOP20200043A1 (ar) | 2011-05-10 | 2017-06-16 | Amgen Inc | طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول |
| WO2013012022A1 (ja) | 2011-07-19 | 2013-01-24 | 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 |
| CN104023748B (zh) * | 2011-10-28 | 2018-03-02 | 诚信生物公司 | 含有氨基酸的蛋白质制剂 |
| 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 |
| WO2013186230A1 (en) | 2012-06-12 | 2013-12-19 | 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 |
| MX388858B (es) | 2014-10-23 | 2025-03-20 | Amgen Inc | Reducción de la viscosidad de formulaciones farmacéuticas |
| MX388043B (es) | 2014-12-03 | 2025-03-19 | Csl Behring Ag | Producto farmacéutico con estabilidad incrementada que comprende inmunoglobulinas. |
| CA3038909A1 (en) | 2016-09-29 | 2018-04-05 | Amgen Inc. | Low-viscosity antigen binding proteins and methods of making them |
| WO2018067987A1 (en) | 2016-10-06 | 2018-04-12 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| 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 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 EA EA202191513A patent/EA202191513A1/ru unknown
- 2015-10-22 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 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
-
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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