ES2897500T3 - Formulaciones de anticuerpos T1h - Google Patents
Formulaciones de anticuerpos T1h Download PDFInfo
- Publication number
- ES2897500T3 ES2897500T3 ES20174783T ES20174783T ES2897500T3 ES 2897500 T3 ES2897500 T3 ES 2897500T3 ES 20174783 T ES20174783 T ES 20174783T ES 20174783 T ES20174783 T ES 20174783T ES 2897500 T3 ES2897500 T3 ES 2897500T3
- Authority
- ES
- Spain
- Prior art keywords
- histidine
- formulation
- antibody
- formulations
- buffer
- 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.)
- Active
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 [IG], e.g. monoclonal or polyclonal antibodies
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2859CH2009 | 2009-11-20 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| ES2897500T3 true ES2897500T3 (es) | 2022-03-01 |
| ES2897500T8 ES2897500T8 (es) | 2022-03-10 |
Family
ID=44059267
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES20174783T Active ES2897500T3 (es) | 2009-11-20 | 2010-11-19 | Formulaciones de anticuerpos T1h |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US20120231009A1 (https=) |
| EP (2) | EP2501408B1 (https=) |
| JP (2) | JP5896471B2 (https=) |
| KR (1) | KR101333276B1 (https=) |
| CN (1) | CN102770157B (https=) |
| AU (1) | AU2010320515B2 (https=) |
| BR (1) | BR112012012080B1 (https=) |
| CA (1) | CA2781467C (https=) |
| CU (1) | CU20120080A7 (https=) |
| DK (1) | DK3721904T3 (https=) |
| ES (1) | ES2897500T3 (https=) |
| IL (1) | IL219884A (https=) |
| MX (1) | MX2012005863A (https=) |
| MY (1) | MY165614A (https=) |
| NZ (1) | NZ600096A (https=) |
| PL (1) | PL3721904T3 (https=) |
| PT (1) | PT3721904T (https=) |
| RU (1) | RU2548772C2 (https=) |
| WO (1) | WO2011061712A1 (https=) |
| ZA (1) | ZA201204459B (https=) |
Families Citing this family (37)
| 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) |
| WO2009113083A1 (en) | 2008-03-14 | 2009-09-17 | Biocon Limited | A monoclonal antibody and a method 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 |
| SG192117A1 (en) | 2011-01-28 | 2013-08-30 | Sanofi Sa | Human antibodies to pcsk9 for use in methods of treating particular groups of subjects |
| JOP20200043A1 (ar) | 2011-05-10 | 2017-06-16 | Amgen Inc | طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| HUE069234T2 (hu) | 2011-09-16 | 2025-02-28 | Regeneron Pharma | Eljárások lipoprotein(a)-szint csökkentésére proprotein-konvertáz szubtilizin/kexin 9 (PCSK9) inhibitorának beadásával |
| KR102063028B1 (ko) | 2012-01-23 | 2020-01-07 | 리제너론 파아마슈티컬스, 인크. | 항-ａｎｇ2 항체를 함유하는 안정화된 제형 |
| 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 |
| AR092325A1 (es) | 2012-05-31 | 2015-04-15 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit |
| PE20150964A1 (es) | 2012-09-07 | 2015-07-25 | 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 |
| CN104780940B (zh) | 2012-11-06 | 2017-11-07 | 拜耳制药股份公司 | 用于双特异性t细胞衔接体(bites)的制剂 |
| 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) |
| EP3024485B1 (en) | 2013-07-23 | 2020-11-18 | Biocon Limited | Use of a cd6 binding partner and method based thereon |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| CN118105480A (zh) | 2013-11-12 | 2024-05-31 | 赛诺菲生物技术公司 | 用于与pcsk9抑制剂一起使用的给药方案 |
| WO2015181757A1 (en) * | 2014-05-28 | 2015-12-03 | Nono Inc. | Lyophilized formulation of tat-nr2b9c with acetylation scavenger |
| KR20230074283A (ko) | 2014-07-16 | 2023-05-26 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
| AU2015325055B2 (en) | 2014-10-01 | 2021-02-25 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| 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 |
| JP2018523684A (ja) | 2015-08-18 | 2018-08-23 | 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Ｒｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | リポタンパク質アフェレーシスを受けている高脂血症の患者を治療するための抗ｐｃｓｋ９阻害抗体 |
| 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 |
| KR102546471B1 (ko) * | 2016-09-27 | 2023-06-21 | 프레제니우스 카비 도이치란트 게엠베하 | 액상의 약학 조성물 |
| ES2991182T3 (es) | 2016-10-21 | 2024-12-02 | Biocon Ltd | Un anticuerpo monoclonal y un método de uso para el tratamiento del 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 |
| WO2019180261A1 (en) * | 2018-03-23 | 2019-09-26 | AbbVie Deutschland GmbH & Co. KG | Stable aqueous anti-tau antibody formulations |
| 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 |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| 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 |
| CN117214426A (zh) * | 2023-09-20 | 2023-12-12 | 暨南大学 | 一种用于免疫组织化学检测的抗体稀释液及其制备方法 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2434840T3 (es) * | 1995-07-27 | 2013-12-17 | Genentech, Inc. | Formulación de proteína liofilizada isotónica estable |
| 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 |
| MXPA04000747A (es) * | 2001-07-25 | 2004-07-08 | Protein Desing Labs Inc | Formulacion farmaceutica liofilizada estable de anticuerpos igg. |
| MXPA05010555A (es) * | 2003-04-04 | 2006-03-09 | Genentech Inc | Formulaciones de proteina y anticuerpo de alta concentracion. |
| WO2007142667A2 (en) * | 2005-10-13 | 2007-12-13 | Human Genome Sciences, Inc. | Treatment of patients with autoantibody positive disease |
| CA2654794A1 (en) * | 2006-06-14 | 2007-12-21 | Imclone Systems Incorporated | Lyophilized formulations of anti-egfr antibodies |
| CL2007003583A1 (es) * | 2006-12-11 | 2008-07-18 | Hoffmann La Roche | Formulacion farmaceutica estable, parenteral, del anticuerpo contra el peptido beta amiloide (abeta); y uso de la formulacion para el tratamiento de la enfermedad de alzheimer. |
| 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 |
| KR101482959B1 (ko) * | 2006-12-26 | 2015-01-15 | 센트로 데 인뮤놀러지아 모레큘러 | Ｂ-세포 만성 림프구성 백혈병의 진단 및 치료에 유용한 종양 세포에서 세포사멸을 유도할 수 있는 약학 조성물 |
| CA2674608A1 (en) * | 2007-01-09 | 2008-07-17 | Wyeth | Anti-il-13 antibody formulations and uses thereof |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| EP2170268A2 (en) * | 2007-06-25 | 2010-04-07 | 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 |
| AU2021400284A1 (en) * | 2020-12-15 | 2023-06-22 | Bicara Therapeutics Inc. | Pharmaceutical formulations for fusion proteins |
-
2010
- 2010-11-19 EP EP10831248.9A patent/EP2501408B1/en active Active
- 2010-11-19 NZ NZ600096A patent/NZ600096A/xx unknown
- 2010-11-19 MY MYPI2012002248A patent/MY165614A/en unknown
- 2010-11-19 CA CA2781467A patent/CA2781467C/en active Active
- 2010-11-19 PT PT201747839T patent/PT3721904T/pt unknown
- 2010-11-19 DK DK20174783.9T patent/DK3721904T3/da active
- 2010-11-19 AU AU2010320515A patent/AU2010320515B2/en active Active
- 2010-11-19 RU RU2012125254/15A patent/RU2548772C2/ru active
- 2010-11-19 KR KR1020127015910A patent/KR101333276B1/ko active Active
- 2010-11-19 MX MX2012005863A patent/MX2012005863A/es active IP Right Grant
- 2010-11-19 BR BR112012012080-8A patent/BR112012012080B1/pt active IP Right Grant
- 2010-11-19 PL PL20174783T patent/PL3721904T3/pl unknown
- 2010-11-19 EP EP20174783.9A patent/EP3721904B1/en active Active
- 2010-11-19 WO PCT/IB2010/055296 patent/WO2011061712A1/en not_active Ceased
- 2010-11-19 JP JP2012539465A patent/JP5896471B2/ja active Active
- 2010-11-19 US US13/510,929 patent/US20120231009A1/en not_active Abandoned
- 2010-11-19 ES ES20174783T patent/ES2897500T3/es active Active
- 2010-11-19 CN CN201080060508.0A patent/CN102770157B/zh 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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