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

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

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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 (en) 2006-03-28 2007-03-19 Anti-igf-1r human monoclonal antibody formulation

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

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110070225A1 (en) * 2006-11-12 2011-03-24 Pierre Goldbach Beta antibody parenteral formulation
GB0702888D0 (en) * 2007-02-14 2007-03-28 Glaxo Group Ltd Novel Antibodies
WO2008116103A2 (en) * 2007-03-22 2008-09-25 Imclone Llc Stable antibody formulations
WO2009007272A1 (en) * 2007-07-10 2009-01-15 F. Hoffmann-La Roche Ag Novel formulation
US20100249384A1 (en) * 2007-11-29 2010-09-30 Stefan Hepbildikler Immunoglobulin aggregates
CN105126099A (zh) * 2007-12-21 2015-12-09 弗·哈夫曼-拉罗切有限公司 抗体制剂
WO2010069858A1 (en) * 2008-12-19 2010-06-24 F. Hoffmann-La Roche Ag Pharmaceutical composition
US20100316639A1 (en) 2009-06-16 2010-12-16 Genentech, Inc. Biomarkers for igf-1r inhibitor therapy
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.
AU2010338305A1 (en) * 2009-12-29 2012-05-24 F. Hoffmann-La Roche Ag Antibody formulation
MX2012013586A (es) * 2010-05-28 2013-01-24 Novo Nordisk As Composiciones multi-dosis estables que comprenden un anticuerpo y un conservante.
JP6014116B2 (ja) 2011-03-31 2016-10-25 メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. ヒト・プログラム死受容体pd−1に対する抗体の安定製剤および関連治療
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
SG11201508911PA (en) 2013-04-29 2015-11-27 Hoffmann La Roche Human fcrn-binding modified antibodies and methods of use
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
MX2016008782A (es) 2014-01-15 2016-09-08 Hoffmann La Roche Variantes de region fc con union mejorada de la proteina a.
CA2950392A1 (en) * 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger
AR102198A1 (es) 2014-10-09 2017-02-08 Regeneron Pharma Proceso para reducir partículas subvisibles en una formulación farmacéutica
IL302486A (en) 2015-06-24 2023-06-01 Hoffmann La Roche Antibodies against the transnephrine receptor with adapted affinity
KR20180054791A (ko) * 2015-09-28 2018-05-24 쑤저우 선카디아 바이오파마수티컬즈 컴퍼니 리미티드 안정한 항-pd-1 항체 약학적 제조물 및 의료에서의 그의 적용
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
PE20231655A1 (es) 2015-10-02 2023-10-17 Hoffmann La Roche Anticuerpos biespecificos contra el cd20 humano y el receptor de transferrina humano y metodos 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
KR102369014B1 (ko) 2016-08-16 2022-03-02 리제너론 파아마슈티컬스, 인크. 혼합물로부터 개별 항체들을 정량하는 방법
KR20230119729A (ko) 2016-10-25 2023-08-16 리제너론 파아마슈티컬스, 인크. 크로마토그래피 데이터 분석을 위한 방법 및 시스템
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CA3060581A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
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
ATE230277T1 (de) * 1997-06-13 2003-01-15 Genentech Inc Stabilisierte antikörperformulierung
JP2004531217A (ja) * 2001-01-05 2004-10-14 ファイザー・インク インスリン様成長因子i受容体に対する抗体
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
ATE549359T1 (de) * 2003-04-02 2012-03-15 Hoffmann La Roche Antikörper gegen den insulinähnlichen wachstumsfaktor i-rezeptor und deren verwendungen
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
DE602004029581D1 (de) * 2003-08-13 2010-11-25 Pfizer Prod Inc Modifizierte humane igf-1r antikörper

Also Published As

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

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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