JP2020511443A5 - - Google Patents
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- Publication number
- JP2020511443A5 JP2020511443A5 JP2019548458A JP2019548458A JP2020511443A5 JP 2020511443 A5 JP2020511443 A5 JP 2020511443A5 JP 2019548458 A JP2019548458 A JP 2019548458A JP 2019548458 A JP2019548458 A JP 2019548458A JP 2020511443 A5 JP2020511443 A5 JP 2020511443A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid pharmaceutical
- pharmaceutical composition
- adalimumab
- composition
- glycerol
- 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
- 239000000203 mixture Substances 0.000 claims description 60
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 45
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 39
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 36
- 239000007788 liquid Substances 0.000 claims description 33
- 239000008194 pharmaceutical composition Substances 0.000 claims description 33
- 229960002964 adalimumab Drugs 0.000 claims description 25
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 24
- FFEARJCKVFRZRR-SCSAIBSYSA-N D-methionine Chemical compound CSCC[C@@H](N)C(O)=O FFEARJCKVFRZRR-SCSAIBSYSA-N 0.000 claims description 16
- 239000007853 buffer solution Substances 0.000 claims description 14
- 239000011780 sodium chloride Substances 0.000 claims description 12
- 239000004475 Arginine Substances 0.000 claims description 10
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 10
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 10
- 235000009697 arginine Nutrition 0.000 claims description 10
- 229930182817 methionine Natural products 0.000 claims description 10
- 229960004452 methionine Drugs 0.000 claims description 10
- 229920005862 polyol Polymers 0.000 claims description 10
- 150000003077 polyols Chemical class 0.000 claims description 10
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims description 8
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 8
- 229930064664 L-arginine Natural products 0.000 claims description 8
- 235000014852 L-arginine Nutrition 0.000 claims description 8
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 8
- 239000008351 acetate buffer Substances 0.000 claims description 8
- 229920001993 poloxamer 188 Polymers 0.000 claims description 8
- 229940044519 poloxamer 188 Drugs 0.000 claims description 8
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 8
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 8
- 229940068977 polysorbate 20 Drugs 0.000 claims description 8
- 239000007974 sodium acetate buffer Substances 0.000 claims description 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 4
- 239000002736 nonionic surfactant Substances 0.000 claims description 4
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims description 2
- 206010009900 Colitis ulcerative Diseases 0.000 claims description 2
- 208000011231 Crohn disease Diseases 0.000 claims description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 2
- 208000003456 Juvenile Arthritis Diseases 0.000 claims description 2
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims description 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 2
- 201000004681 Psoriasis Diseases 0.000 claims description 2
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims description 2
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims description 2
- 201000006704 Ulcerative Colitis Diseases 0.000 claims description 2
- 206010046851 Uveitis Diseases 0.000 claims description 2
- 229960003121 arginine Drugs 0.000 claims description 2
- 201000010099 disease Diseases 0.000 claims description 2
- 208000035475 disorder Diseases 0.000 claims description 2
- 238000012377 drug delivery Methods 0.000 claims description 2
- 238000004108 freeze drying Methods 0.000 claims description 2
- 208000002557 hidradenitis Diseases 0.000 claims description 2
- 201000007162 hidradenitis suppurativa Diseases 0.000 claims description 2
- 239000007951 isotonicity adjuster Substances 0.000 claims description 2
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims description 2
- 229910052708 sodium Inorganic materials 0.000 claims description 2
- 239000011734 sodium Substances 0.000 claims description 2
- 239000008247 solid mixture Substances 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 238000009472 formulation Methods 0.000 description 26
- 239000013628 high molecular weight specie Substances 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 4
- 238000004255 ion exchange chromatography Methods 0.000 description 4
- 229940048921 humira Drugs 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 230000009615 deamination Effects 0.000 description 2
- 238000006481 deamination reaction Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000009295 crossflow filtration Methods 0.000 description 1
- 239000013627 low molecular weight specie Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 238000001542 size-exclusion chromatography Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000005199 ultracentrifugation Methods 0.000 description 1
- 239000012905 visible particle Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17159458.3 | 2017-03-06 | ||
| EP17159458.3A EP3372241A1 (en) | 2017-03-06 | 2017-03-06 | Liquid pharmaceutical composition |
| PCT/EP2018/055509 WO2018162503A1 (en) | 2017-03-06 | 2018-03-06 | Liquid pharmaceutical composition |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020511443A JP2020511443A (ja) | 2020-04-16 |
| JP2020511443A5 true JP2020511443A5 (enExample) | 2021-04-08 |
| JP7220664B2 JP7220664B2 (ja) | 2023-02-10 |
Family
ID=58261542
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019548458A Active JP7220664B2 (ja) | 2017-03-06 | 2018-03-06 | 液体医薬組成物 |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US11534403B2 (enExample) |
| EP (2) | EP3372241A1 (enExample) |
| JP (1) | JP7220664B2 (enExample) |
| WO (1) | WO2018162503A1 (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| GB201703063D0 (en) * | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| EP3372242A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3372241A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2020187760A1 (en) * | 2019-03-18 | 2020-09-24 | Alvotech Hf | Aqueous formulations of tnf-alpha antibodies in high concentrations |
| CN117120070B (zh) * | 2021-03-11 | 2024-11-15 | 89生物公司 | 包含突变型fgf-21肽peg化缀合物的液体制剂 |
| CA3211539A1 (en) | 2021-03-11 | 2022-09-15 | Boris Schwartsburd | Liquid formulations comprising mutant fgf-21 peptide pegylated conjugates |
| WO2023043232A1 (ko) * | 2021-09-16 | 2023-03-23 | 주식회사 에이프로젠 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
Family Cites Families (37)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BRPI9707379C8 (pt) | 1996-02-09 | 2017-12-12 | Abbott Biotech Ltd | composições farmacêuticas compreendendo anticorpo humano recombinante geneticamente engenheirado, e anticorpo humano recombinante geneticamente engenheirado. |
| EP1525889A1 (en) | 2000-05-15 | 2005-04-27 | F. Hoffmann-La Roche Ag | Liquid pharmaceutical composition containing an erythropoietin derivative |
| EP1441589B1 (en) | 2001-11-08 | 2012-05-09 | Abbott Biotherapeutics Corp. | Stable liquid pharmaceutical formulation of igg antibodies |
| PL215168B1 (pl) | 2002-02-27 | 2013-10-31 | Immunex Corp | Formulacja polipeptydowa |
| EP1539212A4 (en) | 2002-07-12 | 2007-05-02 | Medarex Inc | METHOD AND COMPOSITIONS FOR PREVENTING OXIDATIVE DEGRADATION OF PROTEINS |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| BRPI0606867A2 (pt) | 2005-01-28 | 2009-07-21 | Wyeth Corp | formulação lìquida; forma de dosagem unitária farmacêutica; kit; recipiente; método para aumentar a estabilidade de um polipeptìdeo de ligação a antìgeno numa formulação; método para preparar uma forma de dosagem unitária farmacêutica; formulação estável; formulação; e produto terapêutico |
| NZ560844A (en) | 2005-03-08 | 2008-08-29 | Pharmacia & Upjohn Co Llc | Anti-MAdCAM antibody compositions |
| TW200806317A (en) | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| ES2827180T3 (es) | 2006-10-06 | 2021-05-20 | Amgen Inc | Formulaciones de anticuerpos estables |
| US7705132B2 (en) | 2006-10-20 | 2010-04-27 | Amgen Inc. | Stable polypeptide formulations |
| GB0700523D0 (en) | 2007-01-11 | 2007-02-21 | Insense Ltd | The Stabilisation Of Proteins |
| TR201820837T4 (tr) | 2007-06-14 | 2019-01-21 | Biogen Ma Inc | Natalizumab antikor formülasyonları. |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| JP2012510468A (ja) | 2008-11-28 | 2012-05-10 | アボット・ラボラトリーズ | 安定な抗体組成物およびこれを安定させるための方法 |
| WO2010129469A1 (en) * | 2009-05-04 | 2010-11-11 | Abbott Biotechnology Ltd. | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| US20130209465A1 (en) | 2010-07-30 | 2013-08-15 | Arecor Ltd. | Stabilized Aqueous Antibody Compositions |
| CN104998254A (zh) | 2010-11-08 | 2015-10-28 | 基因技术公司 | 皮下施用的抗-il-6受体抗体 |
| GB201112429D0 (en) | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| JP2015506369A (ja) | 2012-01-30 | 2015-03-02 | アレコー リミテッド | 安定化された水性抗体組成物 |
| KR101730694B1 (ko) * | 2012-03-07 | 2017-04-27 | 카딜라 핼쓰캐어 리미티드 | TNF-α 항체의 약제학적 제형 |
| TWI698253B (zh) | 2012-09-07 | 2020-07-11 | 美商柯赫勒斯生物科學有限公司 | 阿達木單抗（ａｄａｌｉｍｕｍａｂ）之穩定水性調配物 |
| CN105051064A (zh) * | 2013-01-24 | 2015-11-11 | 葛兰素史克知识产权开发有限公司 | 抗TNF-α抗原结合蛋白 |
| HUP1400510A1 (hu) * | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
| US20170360929A1 (en) | 2014-12-23 | 2017-12-21 | Pfizer Inc. | Stable aqueous antibody formulation for anti tnf alpha antibodies |
| WO2016109822A1 (en) | 2014-12-31 | 2016-07-07 | Novelmed Therapeutics, Inc. | Formulation of aglycosylated therapeutic antibodies |
| TW201636047A (zh) * | 2015-01-28 | 2016-10-16 | 麥博賽恩斯有限公司 | 抗－ＴＮＦ－α抗體之醫藥調配物 |
| WO2016162819A1 (en) | 2015-04-07 | 2016-10-13 | Lupin Limited | Stable aqueous pharmaceutical composition of anti-tnf alpha antibody |
| GB201612317D0 (en) | 2016-07-15 | 2016-08-31 | Philogen Spa | Antibody compositions |
| US20200069799A1 (en) | 2018-08-28 | 2020-03-05 | Arecor Limited | Stabilized antibody protein solutions |
| GB201703062D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| GB201703063D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| EP3372241A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3372242A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2018184692A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
| WO2018184693A1 (en) | 2017-04-07 | 2018-10-11 | Ares Trading S.A. | Liquid pharmaceutical composition |
-
2017
- 2017-03-06 EP EP17159458.3A patent/EP3372241A1/en not_active Withdrawn
-
2018
- 2018-03-06 JP JP2019548458A patent/JP7220664B2/ja active Active
- 2018-03-06 EP EP18714446.4A patent/EP3592385B1/en active Active
- 2018-03-06 US US16/491,506 patent/US11534403B2/en active Active
- 2018-03-06 WO PCT/EP2018/055509 patent/WO2018162503A1/en not_active Ceased
-
2022
- 2022-12-01 US US18/072,852 patent/US20230233463A1/en not_active Abandoned
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