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AU2007229554A1 - Anti-IGF-1R human monoclonal antibody formulation - Google Patents

Anti-IGF-1R human monoclonal antibody formulation Download PDF

Info

Publication number
AU2007229554A1
AU2007229554A1 AU2007229554A AU2007229554A AU2007229554A1 AU 2007229554 A1 AU2007229554 A1 AU 2007229554A1 AU 2007229554 A AU2007229554 A AU 2007229554A AU 2007229554 A AU2007229554 A AU 2007229554A AU 2007229554 A1 AU2007229554 A1 AU 2007229554A1
Authority
AU
Australia
Prior art keywords
igf
mlhumab
histidine
polysorbate
nac1
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.)
Abandoned
Application number
AU2007229554A
Other languages
English (en)
Inventor
Adelbert Grossmann
Hanns-Christian Mahler
Astrid Pappenberger
Oliver Boris Stauch
Jan Olaf Stracke
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.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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 F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Publication of AU2007229554A1 publication Critical patent/AU2007229554A1/en
Abandoned legal-status Critical Current

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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K9/0012Galenical 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins 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)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
AU2007229554A 2006-03-28 2007-03-19 Anti-IGF-1R human monoclonal antibody formulation Abandoned AU2007229554A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP06111848 2006-03-28
EP06111848.5 2006-03-28
PCT/EP2007/052569 WO2007110339A1 (fr) 2006-03-28 2007-03-19 Formulation d'anticorps monoclonal humain anti-igf-1r

Publications (1)

Publication Number Publication Date
AU2007229554A1 true AU2007229554A1 (en) 2007-10-04

Family

ID=37025222

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2007229554A Abandoned AU2007229554A1 (en) 2006-03-28 2007-03-19 Anti-IGF-1R human monoclonal antibody formulation

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 (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
BRPI0809112A2 (pt) * 2007-03-22 2014-08-26 Imclone Llc Formulações estáveis de anticorpos
WO2009007272A1 (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
AU2008340429C1 (en) * 2007-12-21 2016-09-08 F. Hoffmann-La Roche Ag 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.
CA2783715A1 (fr) * 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Nouvelle formation d'anticorps
US20130136733A1 (en) * 2010-05-28 2013-05-30 Novo Nordisk A/S Stable Multi-Dose Compositions Comprising an Antibody and a Preservative
AU2012236479B2 (en) 2011-03-31 2016-10-20 Merck Sharp & Dohme Llc Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments
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
JP2016528167A (ja) 2013-04-29 2016-09-15 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft ヒトFcRn結合改変抗体及び使用方法
CN105164157B (zh) 2013-04-29 2024-05-28 豪夫迈·罗氏有限公司 Fc-受体结合的修饰的非对称抗体及使用方法
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
WO2015107015A1 (fr) 2014-01-15 2015-07-23 F. Hoffmann-La Roche Ag Variants de région fc présentant une liaison améliorée à la protéine a
CA2950392A1 (fr) * 2014-05-28 2015-12-03 Nono Inc. Formulation lyophilisee de tat-nr2b9c avec capteur d'acetylation
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
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
UA123053C2 (uk) 2015-06-24 2021-02-10 Ф. Хоффманн-Ля Рош Аг Антитіло до рецептора трансферину зі спеціально підібраною афінністю
JP6921062B2 (ja) * 2015-09-28 2021-08-18 スーヂョウ サンケイディア バイオファーマスーティカルズ カンパニー リミテッド 安定な抗pd−1抗体医薬製剤および医薬におけるその適用
MA43023A (fr) 2015-10-02 2018-08-08 Hoffmann La Roche Anticorps de récepteur de la transferrine humaine/anti-humaine cd20 bispécifique et leurs procédés d'utilisation
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
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
US11020686B2 (en) 2016-08-16 2021-06-01 Regeneron Pharmaceuticals, Inc. Methods for quantitating individual antibodies from a mixture
BR112019006689A2 (pt) 2016-10-25 2019-06-25 Regeneron Pharma métodos e sistemas para análise de dados de cromatografia
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
US12042538B2 (en) 2017-09-19 2024-07-23 Regeneron Pharmaceuticals, Inc. Methods of reducing particle formation and compositions formed thereby
TWI853823B (zh) 2018-07-02 2024-09-01 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
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
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
EP0999853B1 (fr) * 1997-06-13 2003-01-02 Genentech, Inc. Formulation stabilisee renfermant un anticorps
MA26040A1 (fr) * 2001-01-05 2004-04-01 Pfizer Des anticorps pour recepteur i de facteur de croissance insulinique
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
US7378503B2 (en) * 2003-04-02 2008-05-27 Hoffmann-La Roche Inc. Antibodies against insulin-like growth factor 1 receptor and uses thereof
HRP20050934B1 (hr) * 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
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
JP4638870B2 (ja) * 2003-08-13 2011-02-23 ファイザー・プロダクツ・インク 修飾ヒトigf−1r抗体

Also Published As

Publication number Publication date
CL2007000797A1 (es) 2008-01-25
CA2647111A1 (fr) 2007-10-04
TW200815029A (en) 2008-04-01
NO20083895L (no) 2008-10-24
MX2008012295A (es) 2008-10-09
MA30345B1 (fr) 2009-04-01
CR10295A (es) 2008-10-06
IL193904A0 (en) 2011-08-01
KR20080104160A (ko) 2008-12-01
WO2007110339A1 (fr) 2007-10-04
JP2009531371A (ja) 2009-09-03
RU2008142359A (ru) 2010-05-10
AR060130A1 (es) 2008-05-28
ECSP088778A (es) 2008-10-31
EP1998806A1 (fr) 2008-12-10
BRPI0709229A2 (pt) 2011-06-28
CN101410137A (zh) 2009-04-15

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Legal Events

Date Code Title Description
MK3 Application lapsed section 142(2)(c) - examination deferred under section 46 no request for examination