JP2017531682A5 - - Google Patents
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- Publication number
- 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) | EP3909611B1 (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) | EA033444B1 (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 |
| MA46466A (fr) | 2016-10-06 | 2019-08-14 | Amgen Inc | Formulations pharmaceutiques de protéines à viscosité réduite |
| 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 |
| WO2018200533A1 (en) | 2017-04-28 | 2018-11-01 | Amgen Inc. | Excipients to reduce the viscosity of antibody formulations and formulation compositions |
| AU2018258676B2 (en) * | 2017-04-28 | 2024-09-19 | Amgen Inc. | N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides |
| SG11202003754YA (en) | 2017-05-16 | 2020-05-28 | Bhamis Research Laboratory Pvt Ltd | High concentration protein formulations with reduced viscosity |
| PE20200678A1 (es) | 2017-06-16 | 2020-06-11 | Zealand Pharma As | Posologias para la administracion de analogos de peptido de tipo glucagon-2 (glp-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 |
| BR112020026492A2 (pt) | 2018-07-05 | 2021-04-06 | Bayer Aktiengesellschaft | Método para a produção de péletes liofilizados compreendendo um anticorpo antifator de coagulação xia (fxia) |
| KR20210052389A (ko) | 2018-08-27 | 2021-05-10 | 리제너론 파마슈티칼스 인코포레이티드 | 다운스트림 정제에서의 라만 분광법의 사용 |
| EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| WO2020219550A1 (en) * | 2019-04-23 | 2020-10-29 | Amgen Inc. | The use of low molecular weight polyvinylpyrrolidone (pvp) to reduce viscosity of high concentration protein formulations |
| IL295042A (en) * | 2020-02-13 | 2022-09-01 | Amgen Inc | Formulations of human anti-tslp antibodies and methods of treating inflammatory disease |
| KR102746418B1 (ko) * | 2020-12-03 | 2024-12-26 | 동국대학교 산학협력단 | N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물 |
| WO2022191550A1 (ko) * | 2021-03-09 | 2022-09-15 | (주)지아이이노베이션 | ＩｇＥ Ｆｃ 수용체의 알파 서브유닛의 세포외 도메인을 포함하는 융합단백질의 제형 |
| CN117355321A (zh) * | 2021-04-09 | 2024-01-05 | 安万托特性材料股份有限公司 | 增强性能的赋形剂以及降低生物制剂的粘度和提高生物制剂的稳定性的方法 |
| 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 |
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 |
| WO1999024063A1 (en) | 1997-11-07 | 1999-05-20 | Chiron Corporation | Compositions providing for increased igf-i solubility |
| 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 |
| AU4458401A (en) | 2000-03-31 | 2001-10-15 | Kirin Brewery | Powdery preparation for transmucosal administration containing a polymeric form of drug and exhibiting improved storage stability |
| US6994847B2 (en) | 2000-11-07 | 2006-02-07 | Chiron Corporation | Stabilized interferon compositions |
| AU2002332628B2 (en) | 2001-08-23 | 2007-07-26 | Genmab A/S | Human antibodies specific for interleukin 15 (IL-15) |
| MXPA04008215A (es) | 2002-02-27 | 2004-11-26 | Immunex Corp | Formulacion polipeptidica. |
| WO2004055164A2 (en) | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| CA2512174A1 (en) | 2003-01-30 | 2004-08-12 | Christian B. Allan | Anti-integrin .alpha..nu..beta.3 antibody formulations and uses thereof |
| 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 |
| US7906625B2 (en) | 2005-01-24 | 2011-03-15 | 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 |
| EP2170957A1 (en) | 2007-06-20 | 2010-04-07 | Irm, Llc | Methods and compositions for treating allergic diseases |
| 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 |
| JP5840364B2 (ja) * | 2007-11-30 | 2016-01-06 | アッヴィ バイオテクノロジー リミテッド | タンパク質製剤及びその製造方法 |
| CA2711984A1 (en) * | 2008-01-15 | 2009-07-23 | Abbott Gmbh & Co. Kg | Powdered protein compositions and methods of making same |
| 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 |
| BR112012011539A8 (pt) * | 2009-11-17 | 2017-12-26 | Ipsen Pharma Sas | formulação para a combinação de hgh e rhigf-1 |
| CA2788863C (en) * | 2010-02-04 | 2020-07-07 | Reinhard Franz Bolli | Immunoglobulin preparation |
| EP3409289B1 (en) * | 2010-02-26 | 2020-09-30 | Novo Nordisk A/S | Stable antibody containing compositions |
| WO2011109415A2 (en) | 2010-03-02 | 2011-09-09 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
| MX2012012743A (es) | 2010-05-03 | 2012-11-23 | Genentech Inc | Composiciones y metodos utiles para reducir la viscosidad de formulaciones que contienen proteina. |
| 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 |
| EP2735315B1 (en) | 2011-07-19 | 2019-10-02 | Chugai Seiyaku Kabushiki Kaisha | Stable protein-containing preparation containing argininamide or valinamide |
| WO2013063510A1 (en) * | 2011-10-28 | 2013-05-02 | Integritybio 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 |
| US20150150982A1 (en) | 2012-06-12 | 2015-06-04 | 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 |
| AU2015357068B2 (en) | 2014-12-03 | 2021-07-29 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| SG10201912565QA (en) | 2016-09-29 | 2020-02-27 | Amgen Inc | Low-viscosity antigen binding proteins and methods of making them |
| MA46466A (fr) | 2016-10-06 | 2019-08-14 | Amgen Inc | Formulations pharmaceutiques de protéines à viscosité réduite |
| 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 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 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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