JP2020511440A5 - - Google Patents
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- Publication number
- JP2020511440A5 JP2020511440A5 JP2019548380A JP2019548380A JP2020511440A5 JP 2020511440 A5 JP2020511440 A5 JP 2020511440A5 JP 2019548380 A JP2019548380 A JP 2019548380A JP 2019548380 A JP2019548380 A JP 2019548380A JP 2020511440 A5 JP2020511440 A5 JP 2020511440A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid pharmaceutical
- pharmaceutical composition
- adalimumab
- glycerol
- edta
- 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
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 66
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 60
- 239000000203 mixture Substances 0.000 claims description 58
- 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 36
- 239000008194 pharmaceutical composition Substances 0.000 claims description 36
- 229960002964 adalimumab Drugs 0.000 claims description 31
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 24
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 24
- 229920005862 polyol Polymers 0.000 claims description 19
- 150000003077 polyols Chemical class 0.000 claims description 19
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims description 14
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 14
- 239000008351 acetate buffer Substances 0.000 claims description 14
- 239000007853 buffer solution Substances 0.000 claims description 14
- 229920001993 poloxamer 188 Polymers 0.000 claims description 14
- 229940044519 poloxamer 188 Drugs 0.000 claims description 14
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 14
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 14
- 229940068977 polysorbate 20 Drugs 0.000 claims description 14
- 239000007974 sodium acetate buffer Substances 0.000 claims description 14
- 239000011780 sodium chloride Substances 0.000 claims description 12
- 239000004475 Arginine Substances 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
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 4
- 239000002736 nonionic surfactant Substances 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 3
- 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
- 208000003456 Juvenile Arthritis Diseases 0.000 claims description 2
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims description 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 2
- 229930064664 L-arginine Natural products 0.000 claims description 2
- 235000014852 L-arginine Nutrition 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
- 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
- 239000007951 isotonicity adjuster Substances 0.000 claims description 2
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims description 2
- 239000008247 solid mixture Substances 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 206010000269 abscess Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 210000000106 sweat gland Anatomy 0.000 claims 1
- 238000009472 formulation Methods 0.000 description 28
- 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
- 239000013627 low molecular weight specie Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- 238000009295 crossflow filtration Methods 0.000 description 1
- 208000002557 hidradenitis Diseases 0.000 description 1
- 201000007162 hidradenitis suppurativa Diseases 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction 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
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023018934A JP2023058632A (ja) | 2017-03-06 | 2023-02-10 | 液体医薬組成物 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17159460.9 | 2017-03-06 | ||
| EP17159460.9A EP3372242A1 (en) | 2017-03-06 | 2017-03-06 | Liquid pharmaceutical composition |
| PCT/EP2018/055505 WO2018162500A1 (en) | 2017-03-06 | 2018-03-06 | Liquid pharmaceutical composition |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023018934A Division JP2023058632A (ja) | 2017-03-06 | 2023-02-10 | 液体医薬組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020511440A JP2020511440A (ja) | 2020-04-16 |
| JP2020511440A5 true JP2020511440A5 (https=) | 2021-04-08 |
| JP7357540B2 JP7357540B2 (ja) | 2023-10-06 |
Family
ID=58261543
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019548380A Active JP7357540B2 (ja) | 2017-03-06 | 2018-03-06 | 液体医薬組成物 |
| JP2023018934A Pending JP2023058632A (ja) | 2017-03-06 | 2023-02-10 | 液体医薬組成物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023018934A Pending JP2023058632A (ja) | 2017-03-06 | 2023-02-10 | 液体医薬組成物 |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US11534402B2 (https=) |
| EP (2) | EP3372242A1 (https=) |
| JP (2) | JP7357540B2 (https=) |
| WO (1) | WO2018162500A1 (https=) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| 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 |
| KR102735988B1 (ko) * | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| CN113727730A (zh) * | 2019-03-18 | 2021-11-30 | 阿尔沃科技Hf公司 | 高浓度TNFα抗体的含水制剂 |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK0929578T3 (da) | 1996-02-09 | 2003-08-25 | Abbott Lab Bermuda Ltd | Humane antistoffer, der binder human TNFalfa |
| PL219131B1 (pl) | 2000-05-15 | 2015-03-31 | Hoffmann La Roche | Ciekła kompozycja farmaceutyczna, sposób jej wytwarzania oraz jej zastosowanie |
| JP5290489B2 (ja) | 2001-11-08 | 2013-09-18 | アッヴィ・バイオセラピューティクス・インコーポレイテッド | Ｉｇｇ抗体の安定な液体医薬製剤 |
| PT1946776T (pt) | 2002-02-27 | 2017-03-17 | Immunex Corp | Composição de tnfr-fc estabilizada compreendendo arginina |
| CA2492143A1 (en) | 2002-07-12 | 2004-01-22 | Medarex, Inc. | Methods 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 |
| EP1871806A2 (en) | 2005-03-08 | 2008-01-02 | Pharmacia & Upjohn Company LLC | ANTI-MAdCAM ANTIBODY COMPOSITIONS |
| TW200806317A (en) | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| EP2081553B1 (en) | 2006-10-06 | 2020-08-12 | Amgen Inc. | Stable antibody formulations |
| 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 |
| EP2170390B1 (en) | 2007-06-14 | 2018-11-07 | Biogen MA Inc. | Natalizumab antibody formulations |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| WO2010062896A1 (en) | 2008-11-28 | 2010-06-03 | Abbott Laboratories | Stable antibody compositions and methods for stabilizing same |
| MX2011011772A (es) * | 2009-05-04 | 2012-02-08 | Abbott Biotech Ltd | Formulaicones estables de anticuerpos humanos anti-tnf-alfa con alta concentracion de proteina. |
| EP2598167B1 (en) | 2010-07-30 | 2015-04-01 | Arecor Limited | Stabilized aqueous antibody compositions |
| TWI603738B (zh) | 2010-11-08 | 2017-11-01 | 建南德克公司 | 皮下投予抗－ｉｌ－６受體抗體 |
| GB201112429D0 (en) * | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| CN104203282A (zh) | 2012-01-30 | 2014-12-10 | 艾瑞克有限公司 | 稳定的水性抗体组合物 |
| WO2013164837A1 (en) | 2012-03-07 | 2013-11-07 | Cadila Healthcare Limited | Pharmaceutical formulations of tnf-alpha antibodies |
| WO2014039903A2 (en) * | 2012-09-07 | 2014-03-13 | Coherus Biosciences, Inc. | Stable aqueous formulations of adalimumab |
| CA2898262A1 (en) | 2013-01-24 | 2014-07-31 | Glaxosmithkline Intellectual Property Development Limited | Tnf-alpha antigen-binding proteins |
| HUP1400510A1 (hu) * | 2014-10-28 | 2016-05-30 | Richter Gedeon Nyrt | Gyógyászati TNFalfa ellenes antitest készítmény |
| EP3237000A1 (en) * | 2014-12-23 | 2017-11-01 | Pfizer Inc | Stable aqueous antibody formulation for anti tnf alpha antibodies |
| JP2018500380A (ja) | 2014-12-31 | 2018-01-11 | ノベルメド セラピューティクス，インコーポレーテッド | アグリコシル化治療用抗体の製剤 |
| 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 |
| GB201703062D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| GB201703063D0 (en) | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
| US20200069799A1 (en) | 2018-08-28 | 2020-03-05 | 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 |
| 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 EP17159460.9A patent/EP3372242A1/en not_active Withdrawn
-
2018
- 2018-03-06 WO PCT/EP2018/055505 patent/WO2018162500A1/en not_active Ceased
- 2018-03-06 US US16/491,500 patent/US11534402B2/en active Active
- 2018-03-06 JP JP2019548380A patent/JP7357540B2/ja active Active
- 2018-03-06 EP EP18710815.4A patent/EP3592383B1/en active Active
-
2022
- 2022-12-01 US US18/072,841 patent/US20230330014A1/en not_active Abandoned
-
2023
- 2023-02-10 JP JP2023018934A patent/JP2023058632A/ja active Pending
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