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) | 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) | 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 |
|---|---|---|---|---|
| BR112017008125B1 (pt) | 2014-10-23 | 2023-11-21 | Amgen Inc. | Método para a redução da viscosidade de formulações farmacêuticas, formulações farmacêuticas, método de preparação de um pó liofilizado, pó liofilizado e método para reconstituição de um pó liofilizado |
| 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 |
| MA48461A (fr) | 2017-04-28 | 2020-03-04 | Amgen Inc | Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation |
| 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 |
| SG11202003754YA (en) | 2017-05-16 | 2020-05-28 | Bhamis Research Laboratory Pvt Ltd | High concentration protein formulations with reduced viscosity |
| IL299864B2 (en) | 2017-06-16 | 2024-06-01 | Zealand Pharma As | Dosage regimes for the administration of glucagon-like-peptide-2 (glp-2) analogues |
| EP3685849A4 (en) * | 2017-09-22 | 2021-12-22 | Asahi Kasei Pharma Corporation | LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH 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 |
| CN112543627A (zh) | 2018-07-05 | 2021-03-23 | 拜耳公司 | 新型稳定的高浓度抗FXIa抗体制剂 |
| JP2021535739A (ja) | 2018-08-27 | 2021-12-23 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 下流精製でのラマン分光法の使用 |
| EP3628683A1 (en) * | 2018-09-28 | 2020-04-01 | Zealand Pharma A/S | Formulations of glucagon-like-peptide-2 (glp-2) analogues |
| JP7739182B2 (ja) * | 2019-04-23 | 2025-09-16 | アムジエン・インコーポレーテツド | 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用 |
| 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 |
| CN116963721A (zh) * | 2021-03-09 | 2023-10-27 | Gi 医诺微新 | 包含IgE Fc受体的α亚基的胞外结构域的融合蛋白的制剂 |
| KR20230167123A (ko) * | 2021-04-09 | 2023-12-07 | 아반토 퍼포먼스 머티리얼즈, 엘엘씨 | 성능-강화 부형제 및 생물학적 제형의 점성을 낮추고 안정성을 높이는 방법 |
| 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 |
| US6767892B1 (en) * | 1997-11-07 | 2004-07-27 | Chrion Corporation | Compositions providing for increased IGF-I solubility |
| DE69814133T2 (de) * | 1997-11-07 | 2004-04-01 | Chiron Corp. (N.D.Ges.D. Staates Delaware), Emeryville | Zusammensetzung um die löslichkeit von igf-i zu erhöhen |
| 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 |
| PL209928B1 (pl) | 2000-11-07 | 2011-11-30 | Novartis Vaccines & Diagnostic | Kompozycja farmaceutyczna zawierająca biologicznie aktywny IFN-β i mannitol, wstępnie napełniona strzykawka zawierająca tę kompozycję oraz sposób wytwarzania preparatu IFN-β |
| MXPA04001486A (es) | 2001-08-23 | 2004-10-27 | Genmab As | Anticuerpos humanos especificos para interleucina 15 (il-15). |
| 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 |
| EP1589996A4 (en) | 2003-01-30 | 2009-01-21 | Medimmune Inc | ANTI-INTEGRIN ALPHA BETA 3 ANTIBODY FORMULATIONS AND ITS USES |
| 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 |
| 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 | STABILIZER PREPARATION CONTAINING ANTIBODIES |
| 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 |
| KR20090088950A (ko) | 2006-12-14 | 2009-08-20 | 쉐링 코포레이션 | 가공된 항-ｔｓｌｐ 항체 |
| US8101182B2 (en) | 2007-06-20 | 2012-01-24 | Novartis Ag | 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 |
| TWI629064B (zh) * | 2007-11-30 | 2018-07-11 | 艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
| EP2249809A1 (en) * | 2008-01-15 | 2010-11-17 | 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 |
| US20120270782A1 (en) * | 2009-11-17 | 2012-10-25 | Ipsen Pharma S.A.S. | Formulation for hgh and rhigf-1 combination |
| CA2788863C (en) | 2010-02-04 | 2020-07-07 | Reinhard Franz Bolli | Immunoglobulin preparation |
| CA2789061A1 (en) * | 2010-02-26 | 2011-09-01 | Henrik Parshad | Stable antibody containing compositions |
| 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 |
| EP2735315B1 (en) | 2011-07-19 | 2019-10-02 | Chugai Seiyaku Kabushiki Kaisha | Stable protein-containing preparation containing argininamide or valinamide |
| BR112014010186A2 (pt) * | 2011-10-28 | 2017-05-02 | Integritybio Inc | formulação farmacêutica estável, kit, composição farmacêutica, método para preparar uma formulação farmacêutica, e, método para tratar um humano ou animal |
| 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 |
| BR112017008125B1 (pt) | 2014-10-23 | 2023-11-21 | Amgen Inc. | Método para a redução da viscosidade de formulações farmacêuticas, formulações farmacêuticas, método de preparação de um pó liofilizado, pó liofilizado e método para reconstituição de um pó liofilizado |
| EP3763384B1 (en) | 2014-12-03 | 2024-08-28 | CSL Behring AG | Pharmaceutical product with increased stability comprising immunoglobulins |
| US11059908B2 (en) | 2016-09-29 | 2021-07-13 | 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 BR BR112017008125-3A patent/BR112017008125B1/pt active IP Right Grant
- 2015-10-22 WO PCT/US2015/056972 patent/WO2016065181A1/en not_active Ceased
- 2015-10-22 EA EA201991447A patent/EA038462B1/ru unknown
- 2015-10-22 KR KR1020177011706A patent/KR102534017B1/ko active Active
- 2015-10-22 MA MA054716A patent/MA54716A/fr unknown
- 2015-10-22 CA CA2964786A patent/CA2964786C/en active Active
- 2015-10-22 CN CN201580057461.5A patent/CN107206070B/zh active Active
- 2015-10-22 US US15/521,057 patent/US11813328B2/en active Active
- 2015-10-22 EA EA201790787A patent/EA033444B1/ru not_active IP Right Cessation
- 2015-10-22 EP EP21175309.0A patent/EP3909611B1/en active Active
- 2015-10-22 JP JP2017522169A patent/JP2017531682A/ja active Pending
- 2015-10-22 CN CN202210048275.7A patent/CN114569716A/zh active Pending
- 2015-10-22 MX MX2017005243A patent/MX388858B/es unknown
- 2015-10-22 EP EP15790759.3A patent/EP3209332B1/en active Active
- 2015-10-22 IL IL287947A patent/IL287947B2/en unknown
- 2015-10-22 SG SG11201703152RA patent/SG11201703152RA/en unknown
- 2015-10-22 ES ES21175309T patent/ES2964713T3/es active Active
- 2015-10-22 AU AU2015335743A patent/AU2015335743B2/en active Active
- 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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