JP5896471B2 - 抗体製剤 - Google Patents

抗体製剤 Download PDF

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Publication number
JP5896471B2
JP5896471B2 JP2012539465A JP2012539465A JP5896471B2 JP 5896471 B2 JP5896471 B2 JP 5896471B2 JP 2012539465 A JP2012539465 A JP 2012539465A JP 2012539465 A JP2012539465 A JP 2012539465A JP 5896471 B2 JP5896471 B2 JP 5896471B2
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JP
Japan
Prior art keywords
histidine
trehalose
antibody
formulation
preparation
Prior art date
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Active
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JP2012539465A
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English (en)
Japanese (ja)
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JP2013511510A (ja
Inventor
ラマーニ カルシーク
ラマーニ カルシーク
ジャヤカール スチャリーサ
ジャヤカール スチャリーサ
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Biocon Ltd
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Biocon Ltd
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Classifications

    • 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
    • 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
    • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (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)
JP2012539465A 2009-11-20 2010-11-19 抗体製剤 Active JP5896471B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20
IN2859/CHE/2009 2009-11-20
PCT/IB2010/055296 WO2011061712A1 (en) 2009-11-20 2010-11-19 Formulations of antibody

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015256586A Division JP2016104780A (ja) 2009-11-20 2015-12-28 抗体製剤

Publications (2)

Publication Number Publication Date
JP2013511510A JP2013511510A (ja) 2013-04-04
JP5896471B2 true JP5896471B2 (ja) 2016-03-30

Family

ID=44059267

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2012539465A Active JP5896471B2 (ja) 2009-11-20 2010-11-19 抗体製剤
JP2015256586A Pending JP2016104780A (ja) 2009-11-20 2015-12-28 抗体製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2015256586A Pending JP2016104780A (ja) 2009-11-20 2015-12-28 抗体製剤

Country Status (20)

Country Link
US (4) US20120231009A1 (enExample)
EP (2) EP3721904B1 (enExample)
JP (2) JP5896471B2 (enExample)
KR (1) KR101333276B1 (enExample)
CN (1) CN102770157B (enExample)
AU (1) AU2010320515B2 (enExample)
BR (1) BR112012012080B1 (enExample)
CA (1) CA2781467C (enExample)
CU (1) CU20120080A7 (enExample)
DK (1) DK3721904T3 (enExample)
ES (1) ES2897500T3 (enExample)
IL (1) IL219884A (enExample)
MX (1) MX2012005863A (enExample)
MY (1) MY165614A (enExample)
NZ (1) NZ600096A (enExample)
PL (1) PL3721904T3 (enExample)
PT (1) PT3721904T (enExample)
RU (1) RU2548772C2 (enExample)
WO (1) WO2011061712A1 (enExample)
ZA (1) ZA201204459B (enExample)

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JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
PT2993186T (pt) 2008-03-14 2019-11-29 Biocon Ltd Anticorpo monoclonal e um método do mesmo
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
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).
CA2825778A1 (en) 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
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
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)
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
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
SMT201800335T1 (it) 2012-11-06 2018-09-13 Bayer Pharma AG Formulazione di attivatori bispecifici per linfociti t (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)
US10189899B2 (en) 2013-07-23 2019-01-29 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
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
CA2950392A1 (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
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog 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
EA201890519A1 (ru) 2015-08-18 2018-07-31 Ридженерон Фармасьютикалз, Инк. Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов
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
BR112019005328A2 (pt) * 2016-09-27 2019-06-18 Fresenius Kabi Deutschland Gmbh composição farmacêutica líquida
KR102514528B1 (ko) 2016-10-21 2023-03-27 바이오콘 리미티드 루푸스 치료를 위한 단일클론항체 및 이의 치료방법
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
BR112020019065A2 (pt) * 2018-03-23 2020-12-29 AbbVie Deutschland GmbH & Co. KG Formulações de anticorpo anti-tau aquosas estáveis
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
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
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
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TW202417512A (zh) * 2022-10-17 2024-05-01 英屬開曼群島商百濟神州有限公司 含有抗tigit抗體的配製物及其使用方法
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Also Published As

Publication number Publication date
AU2010320515A1 (en) 2012-06-14
IL219884A (en) 2015-11-30
US20190321285A1 (en) 2019-10-24
PT3721904T (pt) 2021-11-15
CU20120080A7 (es) 2012-10-15
AU2010320515B2 (en) 2013-05-02
WO2011061712A1 (en) 2011-05-26
EP2501408A1 (en) 2012-09-26
CA2781467C (en) 2015-10-13
RU2012125254A (ru) 2013-12-27
KR101333276B1 (ko) 2013-11-27
DK3721904T3 (da) 2021-11-15
CN102770157A (zh) 2012-11-07
NZ600096A (en) 2013-08-30
EP2501408B1 (en) 2020-05-27
MY165614A (en) 2018-04-18
KR20130028894A (ko) 2013-03-20
US20210290525A1 (en) 2021-09-23
EP3721904A1 (en) 2020-10-14
ZA201204459B (en) 2013-02-27
US20120231009A1 (en) 2012-09-13
JP2016104780A (ja) 2016-06-09
EP2501408A4 (en) 2014-10-08
PL3721904T3 (pl) 2022-01-31
US20240058263A1 (en) 2024-02-22
MX2012005863A (es) 2013-01-18
CA2781467A1 (en) 2011-05-26
ES2897500T3 (es) 2022-03-01
RU2548772C2 (ru) 2015-04-20
IL219884A0 (en) 2012-07-31
JP2013511510A (ja) 2013-04-04
BR112012012080A2 (enExample) 2021-11-03
BR112012012080B1 (pt) 2022-11-29
EP3721904B1 (en) 2021-10-13
ES2897500T8 (es) 2022-03-10
CN102770157B (zh) 2017-05-17

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