DK3721904T3 - Formuleringer af t1h-antistof - Google Patents
Formuleringer af t1h-antistof Download PDFInfo
- Publication number
- DK3721904T3 DK3721904T3 DK20174783.9T DK20174783T DK3721904T3 DK 3721904 T3 DK3721904 T3 DK 3721904T3 DK 20174783 T DK20174783 T DK 20174783T DK 3721904 T3 DK3721904 T3 DK 3721904T3
- Authority
- DK
- Denmark
- Prior art keywords
- antibody
- formulations
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2859CH2009 | 2009-11-20 | ||
| EP10831248.9A EP2501408B1 (en) | 2009-11-20 | 2010-11-19 | Formulations of antibody |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3721904T3 true DK3721904T3 (da) | 2021-11-15 |
Family
ID=44059267
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK20174783.9T DK3721904T3 (da) | 2009-11-20 | 2010-11-19 | Formuleringer af t1h-antistof |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US20120231009A1 (da) |
| EP (2) | EP2501408B1 (da) |
| JP (2) | JP5896471B2 (da) |
| KR (1) | KR101333276B1 (da) |
| CN (1) | CN102770157B (da) |
| AU (1) | AU2010320515B2 (da) |
| BR (1) | BR112012012080B1 (da) |
| CA (1) | CA2781467C (da) |
| CU (1) | CU20120080A7 (da) |
| DK (1) | DK3721904T3 (da) |
| ES (1) | ES2897500T3 (da) |
| IL (1) | IL219884A (da) |
| MX (1) | MX2012005863A (da) |
| MY (1) | MY165614A (da) |
| NZ (1) | NZ600096A (da) |
| PL (1) | PL3721904T3 (da) |
| PT (1) | PT3721904T (da) |
| RU (1) | RU2548772C2 (da) |
| WO (1) | WO2011061712A1 (da) |
| ZA (1) | ZA201204459B (da) |
Families Citing this family (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| CA2716919C (en) | 2008-03-14 | 2015-01-20 | Biocon Limited | An anti-cd6 monoclonal antibody and use thereof |
| 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). |
| US20130064834A1 (en) | 2008-12-15 | 2013-03-14 | Regeneron Pharmaceuticals, Inc. | Methods for treating hypercholesterolemia using antibodies to pcsk9 |
| BR112013018740A2 (pt) | 2011-01-28 | 2019-01-08 | Sanofi Sa | anticorpos humanos para pcsk9 para uso em métodos de tratamento de grupos específicos de indivíduos |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| WO2013039969A1 (en) | 2011-09-16 | 2013-03-21 | Regeneron Pharmaceuticals, Inc. | METHODS FOR REDUCING LIPOPROTEIN(a) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9) |
| BR112014017882A2 (pt) | 2012-01-23 | 2017-06-27 | Regeneron Pharma | formulações estabilizadas contendo anticorpos anti-ang-2 |
| AR092325A1 (es) | 2012-05-31 | 2015-04-15 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit |
| ES2784861T3 (es) | 2012-09-07 | 2020-10-01 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| CN102961745B (zh) * | 2012-09-27 | 2015-02-18 | 苏州康聚生物科技有限公司 | 抗体组合物制剂及其应用 |
| RU2679124C2 (ru) | 2012-11-06 | 2019-02-06 | Байер Фарма Акциенгезельшафт | Препарат для биспецифических активаторов т-клеток (bite) |
| US10111953B2 (en) | 2013-05-30 | 2018-10-30 | Regeneron Pharmaceuticals, Inc. | Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9) |
| EP3738613A1 (en) | 2013-07-23 | 2020-11-18 | Biocon Limited | Use of a cd6 binding partner and method based thereon |
| CN105722500B (zh) | 2013-09-11 | 2019-08-30 | 伊戈尔生物药品股份有限公司 | 包含离子性液体的液体蛋白质制剂 |
| AU2014348765A1 (en) | 2013-11-12 | 2016-06-09 | Regeneron Pharmaceuticals, Inc. | Dosing regimens for use with PCSK9 inhibitors |
| US10206878B2 (en) * | 2014-05-28 | 2019-02-19 | Nono Inc. | Lyophilized formulation of TAT-NR2B9C with acetylation scavenger |
| KR20170029613A (ko) | 2014-07-16 | 2017-03-15 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
| MX2017004306A (es) | 2014-10-01 | 2017-12-20 | Eagle Biologics Inc | Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad. |
| CN104922668B (zh) * | 2014-12-10 | 2019-08-23 | 信达生物制药(苏州)有限公司 | 一种稳定的抗vegf抗体制剂及其用途 |
| KR101776879B1 (ko) * | 2015-01-19 | 2017-09-08 | 주식회사 녹십자 | 항-egfr 항체를 포함하는 약학 제제 |
| CA2995645A1 (en) | 2015-08-18 | 2017-02-23 | Regeneron Pharmaceuticals, Inc. | Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
| US10961314B2 (en) * | 2016-09-27 | 2021-03-30 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody |
| US11242401B2 (en) | 2016-10-21 | 2022-02-08 | Biocon Limited | Monoclonal antibody and a method of use for the treatment of lupus |
| CN106800598B (zh) * | 2017-02-09 | 2020-08-07 | 广州桂雨生物科技有限公司 | 一种抗体保存液及其制备方法 |
| CN111110841A (zh) * | 2018-10-31 | 2020-05-08 | 上海君实生物医药科技股份有限公司 | 含有抗pcsk9抗体的稳定制剂 |
| AU2020225202B2 (en) | 2019-02-18 | 2023-10-26 | Eli Lilly And Company | Therapeutic antibody formulation |
| CN113116812A (zh) * | 2019-12-30 | 2021-07-16 | 百奥泰生物制药股份有限公司 | 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用 |
| US11498626B2 (en) * | 2020-11-11 | 2022-11-15 | Rivian Ip Holdings, Llc | Vehicle tailgate assembly |
| CN113289027B (zh) * | 2021-05-18 | 2022-07-01 | 中国兽医药品监察所 | 一种通用型单克隆抗体耐热保护剂 |
| WO2024083074A1 (en) * | 2022-10-17 | 2024-04-25 | Beigene, Ltd. | Formulations containing anti-tigit antibody and methods of use thereof |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0845997A1 (en) * | 1995-07-27 | 1998-06-10 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| US5810597A (en) * | 1996-06-21 | 1998-09-22 | Robert H. Allen, Jr. | Touch activated audio sign |
| JP5485489B2 (ja) | 2000-08-11 | 2014-05-07 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| DE60235013D1 (de) * | 2001-07-25 | 2010-02-25 | Facet Biotech Corp | Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab |
| PL2335725T3 (pl) * | 2003-04-04 | 2017-04-28 | Genentech, Inc. | Preparaty zawierające wysokoskoncentrowane przeciwciała i białka |
| EA015860B1 (ru) * | 2005-10-13 | 2011-12-30 | Хьюман Дженом Сайенсиз, Инк. | Способы лечения аутоиммунных заболеваний при использовании антагониста нейтрокина-альфа |
| WO2007147001A2 (en) * | 2006-06-14 | 2007-12-21 | Imclone Systems Incorporated | Lyophilized formulations of anti-egfr antibodies |
| JP2010512356A (ja) * | 2006-12-11 | 2010-04-22 | エフ．ホフマン−ラ ロシュ アーゲー | 非経口ａベータ抗体製剤 |
| CN101199483B (zh) * | 2006-12-14 | 2011-01-26 | 上海中信国健药业股份有限公司 | 一种稳定的抗her2人源化抗体制剂 |
| CA2676188C (en) * | 2006-12-26 | 2013-02-05 | Centro De Inmunologia Molecular | Pharmaceutical compositions capable of inducing apoptosis in tumour cells, useful for diagnosis and treatment of the b-chronic lymphocytic leukemia |
| PE20081610A1 (es) * | 2007-01-09 | 2008-12-09 | Wyeth Corp | Formulaciones de anticuerpos anti-il-13 y usos de los mismos |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| AU2008269086B2 (en) * | 2007-06-25 | 2014-06-12 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| WO2009037190A2 (en) * | 2007-09-21 | 2009-03-26 | F. Hoffmann-La Roche Ag | Pharmaceutical formulation for il-ir antibody |
-
2010
- 2010-11-19 MY MYPI2012002248A patent/MY165614A/en unknown
- 2010-11-19 US US13/510,929 patent/US20120231009A1/en not_active Abandoned
- 2010-11-19 KR KR1020127015910A patent/KR101333276B1/ko active IP Right Grant
- 2010-11-19 EP EP10831248.9A patent/EP2501408B1/en active Active
- 2010-11-19 ES ES20174783T patent/ES2897500T3/es active Active
- 2010-11-19 CN CN201080060508.0A patent/CN102770157B/zh active Active
- 2010-11-19 PL PL20174783T patent/PL3721904T3/pl unknown
- 2010-11-19 MX MX2012005863A patent/MX2012005863A/es active IP Right Grant
- 2010-11-19 WO PCT/IB2010/055296 patent/WO2011061712A1/en active Application Filing
- 2010-11-19 RU RU2012125254/15A patent/RU2548772C2/ru active
- 2010-11-19 EP EP20174783.9A patent/EP3721904B1/en active Active
- 2010-11-19 BR BR112012012080-8A patent/BR112012012080B1/pt active IP Right Grant
- 2010-11-19 CA CA2781467A patent/CA2781467C/en active Active
- 2010-11-19 NZ NZ600096A patent/NZ600096A/xx unknown
- 2010-11-19 DK DK20174783.9T patent/DK3721904T3/da active
- 2010-11-19 PT PT201747839T patent/PT3721904T/pt unknown
- 2010-11-19 JP JP2012539465A patent/JP5896471B2/ja active Active
- 2010-11-19 AU AU2010320515A patent/AU2010320515B2/en active Active
-
2012
- 2012-05-20 IL IL219884A patent/IL219884A/en active IP Right Grant
- 2012-05-21 CU CU2012000080A patent/CU20120080A7/es unknown
- 2012-06-18 ZA ZA2012/04459A patent/ZA201204459B/en unknown
-
2015
- 2015-12-28 JP JP2015256586A patent/JP2016104780A/ja active Pending
-
2018
- 2018-11-20 US US16/197,228 patent/US20190321285A1/en not_active Abandoned
-
2020
- 2020-10-30 US US17/085,316 patent/US20210290525A1/en not_active Abandoned
-
2023
- 2023-05-19 US US18/199,675 patent/US20240058263A1/en active Pending
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