ES2897500T8 - Formulaciones de anticuerpos T1h - Google Patents

Formulaciones de anticuerpos T1h

Info

Publication number
ES2897500T8
ES2897500T8 ES20174783T ES20174783T ES2897500T8 ES 2897500 T8 ES2897500 T8 ES 2897500T8 ES 20174783 T ES20174783 T ES 20174783T ES 20174783 T ES20174783 T ES 20174783T ES 2897500 T8 ES2897500 T8 ES 2897500T8
Authority
ES
Spain
Prior art keywords
antibody formulations
antibody
formulations
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
Application number
ES20174783T
Other languages
English (en)
Other versions
ES2897500T3 (es
Inventor
Karthik Ramani
Sucharitha Jayakar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biocon Ltd
Original Assignee
Biocon Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biocon Ltd filed Critical Biocon Ltd
Application granted granted Critical
Publication of ES2897500T3 publication Critical patent/ES2897500T3/es
Publication of ES2897500T8 publication Critical patent/ES2897500T8/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
ES20174783T 2009-11-20 2010-11-19 Formulaciones de anticuerpos T1h Active ES2897500T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20

Publications (2)

Publication Number Publication Date
ES2897500T3 ES2897500T3 (es) 2022-03-01
ES2897500T8 true 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 (es)
EP (2) EP3721904B1 (es)
JP (2) JP5896471B2 (es)
KR (1) KR101333276B1 (es)
CN (1) CN102770157B (es)
AU (1) AU2010320515B2 (es)
BR (1) BR112012012080B1 (es)
CA (1) CA2781467C (es)
CU (1) CU20120080A7 (es)
DK (1) DK3721904T3 (es)
ES (1) ES2897500T3 (es)
IL (1) IL219884A (es)
MX (1) MX2012005863A (es)
MY (1) MY165614A (es)
NZ (1) NZ600096A (es)
PL (1) PL3721904T3 (es)
PT (1) PT3721904T (es)
RU (1) RU2548772C2 (es)
WO (1) WO2011061712A1 (es)
ZA (1) ZA201204459B (es)

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BRPI0822447A2 (pt) 2008-03-14 2015-06-16 Biocon Ltd Anticorpo monoclonal e método do mesmo
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
SI2668212T1 (en) 2011-01-28 2018-08-31 Sanofi Biotechnology, Human antibodies against PCSK9 for use in the treatment processes of certain groups of subjects
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
ES2773111T3 (es) 2011-09-16 2020-07-09 Regeneron Pharma Inhibidor de la proproteína convertasa subtilisina/kexina 9 (PCSK9) para su uso en la reducción de los niveles de lipoproteína (a)
JP6113756B2 (ja) 2012-01-23 2017-04-12 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. 抗ang2抗体を含有する安定化製剤
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
PE20191815A1 (es) 2012-09-07 2019-12-27 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
KR20150082328A (ko) 2012-11-06 2015-07-15 바이엘 파마 악티엔게젤샤프트 이중특이성 t-세포 연계체(bites)의 제제
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)
WO2015011658A1 (en) 2013-07-23 2015-01-29 Biocon Limited Use of a cd6 binding partner and method based thereon
EP3808338A1 (en) 2013-09-11 2021-04-21 Eagle Biologics, Inc. Liquid protein formulations containing ionic liquids
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
JP6707469B2 (ja) * 2014-05-28 2020-06-10 ノノ インコーポレイテッド アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤
KR20230074283A (ko) 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
WO2016054259A1 (en) 2014-10-01 2016-04-07 Arsia Therapeutics, 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
CN107922507B (zh) 2015-08-18 2022-04-05 瑞泽恩制药公司 抗pcsk9抑制性抗体用来治疗接受脂蛋白单采的高脂血症患者
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
RU2019112680A (ru) * 2016-09-27 2020-10-29 Фрезениус Каби Дойчланд Гмбх Жидкая фармацевтическая композиция
EP3529274B1 (en) 2016-10-21 2024-04-17 Biocon Limited A 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
UA128098C2 (uk) 2019-02-18 2024-04-03 Елі Ліллі Енд Компані Водна фармацевтична композиція антитіла проти il-17a
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

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AU716785B2 (en) * 1995-07-27 2000-03-09 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
WO2002013860A1 (fr) 2000-08-11 2002-02-21 Chugai Seiyaku Kabushiki Kaisha Preparations stabilisees contenant un anticorps
JP4317010B2 (ja) * 2001-07-25 2009-08-19 ピーディーエル バイオファーマ,インコーポレイティド IgG抗体の安定な凍結乾燥医薬製剤
PT1610820E (pt) * 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
EP3037544A1 (en) * 2005-10-13 2016-06-29 Human Genome Sciences, Inc. Methods and compositions for use in treatment of systemic lupus erythematosus (sle) patients with autoantibody positive diseases
EP2029163A4 (en) * 2006-06-14 2010-08-11 Imclone Llc LYOPHILIZED FORMULATIONS OF ANTI-EGFR ANTIBODIES
EP2094729A1 (en) * 2006-12-11 2009-09-02 F.Hoffmann-La Roche Ag Abeta antibody parenteral formulation
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
US8435521B2 (en) * 2006-12-26 2013-05-07 Centro De Immunolgia Molecular Pharmaceutical compositions capable of inducing apoptosis in tumour cells, useful for diagnosis and treatment of B-chronic lymphocytic leukaemia
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
CA2692165A1 (en) * 2007-06-25 2008-12-31 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

Also Published As

Publication number Publication date
EP2501408A1 (en) 2012-09-26
CA2781467C (en) 2015-10-13
US20210290525A1 (en) 2021-09-23
EP3721904B1 (en) 2021-10-13
US20240058263A1 (en) 2024-02-22
PT3721904T (pt) 2021-11-15
KR20130028894A (ko) 2013-03-20
RU2012125254A (ru) 2013-12-27
US20120231009A1 (en) 2012-09-13
KR101333276B1 (ko) 2013-11-27
PL3721904T3 (pl) 2022-01-31
BR112012012080B1 (pt) 2022-11-29
MX2012005863A (es) 2013-01-18
CN102770157A (zh) 2012-11-07
EP2501408B1 (en) 2020-05-27
CN102770157B (zh) 2017-05-17
CU20120080A7 (es) 2012-10-15
AU2010320515A1 (en) 2012-06-14
ES2897500T3 (es) 2022-03-01
IL219884A0 (en) 2012-07-31
DK3721904T3 (da) 2021-11-15
ZA201204459B (en) 2013-02-27
US20190321285A1 (en) 2019-10-24
IL219884A (en) 2015-11-30
AU2010320515B2 (en) 2013-05-02
RU2548772C2 (ru) 2015-04-20
JP2013511510A (ja) 2013-04-04
NZ600096A (en) 2013-08-30
BR112012012080A2 (es) 2021-11-03
CA2781467A1 (en) 2011-05-26
EP3721904A1 (en) 2020-10-14
JP5896471B2 (ja) 2016-03-30
WO2011061712A1 (en) 2011-05-26
JP2016104780A (ja) 2016-06-09
MY165614A (en) 2018-04-18
EP2501408A4 (en) 2014-10-08

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