KR20080104160A - 항-ｉｇｆ-１ｒ 인간 단일클론 항체 제형 - Google Patents

항-ｉｇｆ-１ｒ 인간 단일클론 항체 제형 Download PDF

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Publication number
KR20080104160A
KR20080104160A KR1020087023673A KR20087023673A KR20080104160A KR 20080104160 A KR20080104160 A KR 20080104160A KR 1020087023673 A KR1020087023673 A KR 1020087023673A KR 20087023673 A KR20087023673 A KR 20087023673A KR 20080104160 A KR20080104160 A KR 20080104160A
Authority
KR
South Korea
Prior art keywords
igf
histidine
polysorbate
formulation
mlhumab
Prior art date
Application number
KR1020087023673A
Other languages
English (en)
Korean (ko)
Inventor
아델베르트 그로스만
한스 크리슈티안 마흘러
아스트리트 파펜베르거
올리버 보리스 스타우쓰
얀 올라프 슈트라케
Original Assignee
에프. 호프만-라 로슈 아게
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 에프. 호프만-라 로슈 아게 filed Critical 에프. 호프만-라 로슈 아게
Publication of KR20080104160A publication Critical patent/KR20080104160A/ko

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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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/0012—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
KR1020087023673A 2006-03-28 2007-03-19 항-ｉｇｆ-１ｒ 인간 단일클론 항체 제형 KR20080104160A (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06111848 2006-03-28
EP06111848.5 2006-03-28

Publications (1)

Publication Number Publication Date
KR20080104160A true KR20080104160A (ko) 2008-12-01

Family

ID=37025222

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020087023673A KR20080104160A (ko) 2006-03-28 2007-03-19 항-ｉｇｆ-１ｒ 인간 단일클론 항체 제형

Country Status (18)

Country Link
EP (1) EP1998806A1 (fr)
JP (1) JP2009531371A (fr)
KR (1) KR20080104160A (fr)
CN (1) CN101410137A (fr)
AR (1) AR060130A1 (fr)
AU (1) AU2007229554A1 (fr)
BR (1) BRPI0709229A2 (fr)
CA (1) CA2647111A1 (fr)
CL (1) CL2007000797A1 (fr)
CR (1) CR10295A (fr)
EC (1) ECSP088778A (fr)
IL (1) IL193904A0 (fr)
MA (1) MA30345B1 (fr)
MX (1) MX2008012295A (fr)
NO (1) NO20083895L (fr)
RU (1) RU2008142359A (fr)
TW (1) TW200815029A (fr)
WO (1) WO2007110339A1 (fr)

Families Citing this family (31)

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AU2007331712A1 (en) * 2006-12-11 2008-06-19 F. Hoffmann-La Roche Ag Abeta antibody parenteral formulation
GB0702888D0 (en) * 2007-02-14 2007-03-28 Glaxo Group Ltd Novel Antibodies
CA2681743A1 (fr) * 2007-03-22 2008-09-25 Imclone Llc Formulations d'anticorps stables
CA2693611A1 (fr) * 2007-07-10 2009-01-15 F. Hoffmann-La Roche Ag Nouvelle formulation
JP5205470B2 (ja) * 2007-11-29 2013-06-05 エフ．ホフマン−ラ ロシュ アーゲー 免疫グロブリン凝集物
UA101487C2 (en) * 2007-12-21 2013-04-10 Ф. Хоффманн-Ля Рош Аг Humanized b-ly1 antibody formulation
WO2010069858A1 (fr) * 2008-12-19 2010-06-24 F. Hoffmann-La Roche Ag Composition pharmaceutique
WO2010146059A2 (fr) 2009-06-16 2010-12-23 F. Hoffmann-La Roche Ag Biomarqueurs pour une thérapie par inhibiteur d'igf-1r
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
SG182304A1 (en) * 2009-12-29 2012-08-30 Hoffmann La Roche Antibody formulation
KR20130086144A (ko) * 2010-05-28 2013-07-31 노보 노르디스크 에이/에스 항체 및 보존제를 포함하는 안정한 다중-투여 조성물
LT2691112T (lt) 2011-03-31 2018-07-25 Merck Sharp & Dohme Corp. Stabilios antikūnų kompozicijos prieš žmogaus programuojamos mirties receptorių pd-1 ir susiję gydymo būdai
CN102363040B (zh) * 2011-10-21 2013-05-01 北京锐瑟科技有限公司 用于粘膜组织的抗微生物肽制剂
CA2904806C (fr) 2013-04-29 2021-11-23 F. Hoffmann-La Roche Ag Anticorps modifies se liant au fcrn humain et procedes d'utilisation
CN103505729B (zh) * 2013-05-24 2015-10-28 华北制药集团新药研究开发有限责任公司 一种稳定的狂犬病毒人源抗体组合制剂
CN104707146B (zh) * 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
RU2698969C2 (ru) 2014-01-15 2019-09-02 Ф.Хоффманн-Ля Рош Аг Варианты fc-области с улучшенной способностью связываться с белком а
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
TW201628649A (zh) * 2014-10-09 2016-08-16 再生元醫藥公司 減少醫藥調配物中微可見顆粒之方法
RU2020124105A (ru) 2015-06-24 2020-09-18 Ф. Хоффманн-Ля Рош Аг Антитела против трансферринового рецептора, обладающие индивидуализированной аффинностью
MX2018003306A (es) * 2015-09-28 2018-05-16 Suzhou Suncadia Biopharmaceuticals Co Ltd Preparacion farmaceutica de anticuerpo anti-pd-1 estable y aplicacion del mismo en medicina.
AR106189A1 (es) 2015-10-02 2017-12-20 Hoffmann La Roche ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO
CR20180149A (es) 2015-10-02 2018-04-05 Hoffmann La Roche Anticuerpos biespecíficos contra el cd20 humano y el receptor de transferrina humano y métodos de uso
CN106199007B (zh) * 2016-08-03 2017-04-05 烟台普罗吉生物科技发展有限公司 蛋白保护剂
MX2019000935A (es) 2016-08-16 2019-07-04 Regeneron Pharma Metodos para cuantificar anticuerpos individuales de una mezcla.
CN109923411B (zh) 2016-10-25 2022-05-31 里珍纳龙药品有限公司 用于色谱数据分析的方法和系统
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
TW202005694A (zh) 2018-07-02 2020-02-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
CN114324882B (zh) * 2020-10-12 2022-12-27 广东菲鹏生物有限公司 蛋白稳定剂及其应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3919235B2 (ja) * 1997-06-13 2007-05-23 ジェネンテク，インコーポレイテッド 抗体製剤
WO2002053596A2 (fr) * 2001-01-05 2002-07-11 Pfizer Inc. Anticorps anti-recepteur du facteur de croissance insulinoide i
DE60235013D1 (de) * 2001-07-25 2010-02-25 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
ES2383014T3 (es) * 2003-04-02 2012-06-15 F. Hoffmann-La Roche Ag Anticuerpos contra el factor I de crecimiento similar a insulina y usos de los mismos
ZA200507757B (en) * 2003-04-04 2007-01-31 Genentech Inc High concentration antibody and protein formulations
AR046071A1 (es) * 2003-07-10 2005-11-23 Hoffmann La Roche Anticuerpos contra el receptor i del factor de crecimiento de tipo insulinico y los usos de los mismos
UA85058C2 (ru) * 2003-08-13 2008-12-25 Пфайзер Продактс Инк. Модифицированное моноклональное антитело человека, которое специфически связывается с рецептором подобного к инсулину фактора роста i человека (igf-ir)

Also Published As

Publication number Publication date
TW200815029A (en) 2008-04-01
AU2007229554A1 (en) 2007-10-04
EP1998806A1 (fr) 2008-12-10
CR10295A (es) 2008-10-06
IL193904A0 (en) 2011-08-01
RU2008142359A (ru) 2010-05-10
MX2008012295A (es) 2008-10-09
ECSP088778A (es) 2008-10-31
CL2007000797A1 (es) 2008-01-25
CN101410137A (zh) 2009-04-15
CA2647111A1 (fr) 2007-10-04
JP2009531371A (ja) 2009-09-03
NO20083895L (no) 2008-10-24
BRPI0709229A2 (pt) 2011-06-28
MA30345B1 (fr) 2009-04-01
WO2007110339A1 (fr) 2007-10-04
AR060130A1 (es) 2008-05-28

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